Acute AppendicitisNCT07841444
Laparoscopic vs Open Appendectomy
A study testing Laparoscopic appendectomy and Open Appendectomy in people with Acute Appendicitis and Superficial SSI, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial summary
his randomized controlled trial was conducted to compare the frequency of superficial surgical site infections (SSIs) following laparoscopic appendectomy and open appendectomy in patients undergoing surgical treatment for acute appendicitis. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Acute Appendicitis, Superficial SSI
- What is being tested?
- Laparoscopic appendectomy and Open Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jan 2026to 23 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 15-60 years of either sex.
- Patients diagnosed with acute appendicitis according to the predefined operational definition and undergoing appendectomy.
- Duration of symptoms less than 48 hours.
- Both elective and emergency appendectomy cases.
Who cannot join
- Patients with generalized peritonitis or perforated appendicitis.
- Patients with significant comorbidities, including uncontrolled diabetes mellitus or immunosuppression.
- Patients with a history of previous abdominal surgery.
- Patients with chronic renal failure, assessed on history and medical records, with serum creatinine >1.5 mg/dL.
- Patients with chronic liver disease, assessed on history and medical records, with serum bilirubin >2 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Frequency of Superficial Surgical Site Infections Between Laparoscopic Versus Open Appendectomy
his randomized controlled trial was conducted to compare the frequency of superficial surgical site infections (SSIs) following laparoscopic appendectomy and open appendectomy in patients undergoing surgical treatment for acute appendicitis. The study was carried out in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over a period of six months from 24 January 2026 to 23 July 2026. A total of 276 patients were included in the study, with 138 participants allocated to each treatment group. Patients enrolled in the trial were assigned to one of two study groups according to the study protocol. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. The purpose of the comparison was to determine whether the operative approach was associated with a difference in the occurrence of superficial surgical site infection after appendectomy. The study therefore evaluated two established surgical approaches for the same clinical condition while maintaining a randomized comparative design.
The primary outcome of the study was the frequency of superficial surgical site infection after appendectomy. Superficial surgical site infection refers to infection involving the skin and subcutaneous tissue at the surgical incision. The occurrence of this postoperative complication was assessed in participants in both groups using the same outcome definition and follow-up approach specified in the study protocol. The frequency of superficial SSI was then compared between the laparoscopic and open appendectomy groups.
Read more
The study was designed as an interventional randomized controlled trial. Participants were assigned to an intervention group on the basis of the study protocol rather than simply being observed according to the treatment they would otherwise have received. The intervention under investigation was the operative approach: laparoscopic appendectomy versus open appendectomy. No investigational drug or biologic product was evaluated, and the study was not conducted under a U.S. Food and Drug Administration Investigational New Drug application. Likewise, the study did not investigate a U.S. FDA-regulated device as the intervention and was not conducted under an Investigational Device Exemption.
The study population consisted of patients undergoing appendectomy at the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur. Eligible participants were enrolled according to the predefined inclusion and exclusion criteria of the study protocol. Participants in the laparoscopic group received appendectomy through the laparoscopic approach, whereas participants in the open group received appendectomy through the conventional open approach. Perioperative care and postoperative assessment were conducted according to the institutional surgical protocol and the requirements of the study. Data were collected prospectively during the study period and were used to assess the postoperative outcome of interest. The incidence of superficial surgical site infection was recorded for participants in each treatment group. The results were subsequently compared between the two groups to determine the observed difference in the frequency of superficial SSI following laparoscopic versus open appendectomy. The analysis was based on the predefined study outcome and the randomized allocation of participants.
The trial was conducted in a hospital surgical setting and included a total sample of 276 participants, providing 138 participants in each group. The study was intended to generate comparative clinical evidence regarding superficial wound infection after the two operative approaches. By directly comparing laparoscopic and open appendectomy within a randomized controlled trial, the study provides a structured assessment of the postoperative wound-related outcome in the enrolled patient population.
The study was undertaken after institutional ethical oversight and approval in accordance with the applicable requirements. Written informed consent was obtained from participants before enrollment, as specified in the study protocol. Participant information was handled confidentially, and study procedures were conducted in accordance with the approved protocol and institutional requirements.
The trial compares superficial surgical site infection between patients undergoing laparoscopic and open appendectomy at the study center. Its focus is the wound outcome associated with the two surgical approaches
Read the detailed description
Acute appendicitis is one of the most common surgical emergencies and appendectomy remains one of the most frequently performed emergency abdominal surgical procedures. Open appendectomy has traditionally been used as the standard operative approach, while laparoscopic appendectomy has increasingly been adopted because of its minimally invasive nature and potential postoperative advantages. Surgical site infection is an important postoperative complication of appendectomy because it can cause additional morbidity, delay wound healing and recovery, increase the need for postoperative treatment and follow-up, and potentially prolong healthcare utilization. The frequency of surgical site infection may vary according to the operative approach, patient characteristics, disease severity, operative technique, and perioperative management.
The present randomized controlled trial was conducted to compare the frequency of superficial surgical site infections following laparoscopic appendectomy and open appendectomy in patients presenting with acute appendicitis. The study was conducted in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over six months, from 24 January 2026 to 23 July 2026. A total of 276 patients were included, with 138 participants allocated to each group.
The study population consisted of patients aged 15 to 60 years of either sex who presented with acute appendicitis and fulfilled the predefined eligibility criteria. Acute appendicitis was diagnosed on the basis of right iliac fossa pain with a visual analogue scale score of 3-10, positive rebound tenderness on clinical examination, and a white blood cell count greater than 10,000/mm³. Patients were eligible if the duration of symptoms was 48 hours or less. Both elective and emergency appendectomies were included.
Patients were excluded if they had generalized peritonitis, perforated appendicitis, uncontrolled diabetes mellitus, immunosuppression, previous abdominal surgery, chronic renal failure with serum creatinine above 1.5 mg/dL, or chronic liver disease with serum bilirubin above 2 mg/dL.
After approval of the study synopsis and institutional ethical approval, eligible patients were enrolled after obtaining informed written consent. Baseline demographic and clinical information was recorded using a structured data collection proforma. Variables included age, sex, duration of symptoms, height, weight, body mass index, obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery.
A body mass index greater than 27 kg/m² was considered obese and 27 kg/m² or below was considered non-obese. Residence was categorized as urban or rural according to documented residential address. Socioeconomic status was categorized according to monthly household income into poor class (≤20,000 PKR), middle class (21,000-40,000 PKR), and upper class (≥41,000 PKR). Diabetes mellitus was recorded on the basis of a known history of diabetes with ongoing treatment and controlled fasting blood glucose below 126 mg/dL on two consecutive measurements.
Participants were randomly allocated in a 1:1 ratio using a lottery method. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All participants received prophylactic antibiotics according to the study protocol, and the duration of postoperative intravenous and outpatient antibiotic therapy was recorded. All operations were performed by the same consultant surgeon with at least five years of post-fellowship experience to maintain consistency in operative technique.
Patients were followed for seven postoperative days. During follow-up, the surgical wound was assessed for superficial surgical site infection and findings were recorded on the structured proforma. The primary outcome was the frequency of superficial surgical site infection within seven postoperative days. Superficial SSI was defined according to the predefined clinical criteria. A patient was considered to have superficial SSI if purulent wound discharge, redness around the wound or stitches, or postoperative fever exceeding 100°F was observed within seven days following surgery. The outcome was recorded as present or absent.
Demographic and clinical characteristics were recorded for comparison between groups. These included age, sex, duration of symptoms, BMI and obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. Stratified analysis of superficial SSI was planned according to these characteristics.
The sample size was calculated using a 5% level of significance and 80% power, based on an anticipated superficial surgical site infection rate of 20% following laparoscopic appendectomy and 35% following open appendectomy. A total of 276 participants were included, with 138 in each group. Consecutive sampling was used for participant enrollment, followed by random allocation using the lottery method.
Operative duration was recorded for each participant and categorized into short and long duration according to the predefined study categorization for stratified analysis.
Statistical analysis was performed using SPSS version 25.0. Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables were expressed as mean ± standard deviation, while non-normally distributed variables were presented as median with interquartile range. Categorical variables were summarized using frequencies and percentages. The independent-samples t-test was used for normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. Categorical variables were compared using the Chi-square test or Fisher's exact test, as appropriate.
The primary outcome was compared between the laparoscopic and open appendectomy groups using the Chi-square test. Stratified analyses were performed according to age group, sex, duration of symptoms, BMI category, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. A p-value of ≤0.05 was considered statistically significant.
The study specifically focused on superficial SSI occurring during the first seven postoperative days and did not combine superficial infection with deep or organ/space surgical site infection. The study was conducted after institutional ethical approval and approval of the study synopsis. Written informed consent was obtained from all participants before enrollment. Participant demographic and clinical information was recorded using a structured proforma, and postoperative wound findings were documented during the seven-day follow-up period.
- Conditions
- Acute Appendicitis, Superficial SSI
- Being tested
- Laparoscopic appendectomy, Open Appendectomy
- Keywords
- Laparoscopic Appendectomy,, Open appendectomy,, Superficial Surgical Site Infection
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
Laparoscopic appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.
Open AppendectomyProcedure or surgery
Open appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Appendectomy | Experimental | Participants assigned to this arm underwent laparoscopic appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F. Receives: Procedure: Laparoscopic appendectomy |
| Open Appendectomy | Active comparator | Participants assigned to this arm underwent open appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F. Receives: Procedure: Open Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy
The primary outcome is the occurrence of superficial surgical site infection within 7 postoperative days after appendectomy. SSI will be recorded as present if the patient develops purulent wound discharge, redness around the wound or stitches, or postoperative fever greater than 100°F during the follow-up period. The frequency of superficial SSI will be compared between the laparoscopic appendectomy and open appendectomy groups.
Measured: Within 7 postoperative days after appendectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start24 Jan 2026
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial comparing laparoscopic appendectomy with open appendectomy in patients aged 15-60 years with acute appendicitis. A total of 276 eligible patients were randomly allocated in a 1:1 ratio using the lottery method, with 138 patients assigned to each group. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All procedures were performed by the same consultant surgeon. Patients were followed for 7 postoperative days to assess the occurrence of superficial surgical site infection. No participant crossed over between intervention groups.
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asad Shabbir, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841444
- Sponsor's protocol ID
- No.517/DME/QAMC Bahawalpur
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study data contain participant-level information and will be retained by the research team in accordance with institutional policies and ethical requirements. Only aggregated, anonymized results will be reported.
Publications
1. Ullah R, Shah M, Babar Y, Khan A. Comparison of laparoscopic and open appendectomy in terms of surgical site infection. Biol Clin Sci Res J. 2024;2024(1):696. doi:10.54112/bcsrj.v2024i1.696. 2. Khazaal AS. Laparoscopic vs open appendectomy: comparison on clinical outcome. World J Lap Surg. 2022;15(1):54-57. doi:10.5005/jp-journals-10033-1484. 3. Gu Q, Hua Y. Perforated appendicitis treated with laparoscopic appendicectomy or open appendicectomy: a meta-analysis. J Minim Access Surg. 2023;19(3):348-54. doi:10.4103/jmas.jmas_158_22. 4. Kumar M, Devkaran B, Verma DK, Mahajan P, Sharma VK, Galodha S. Comparative study of laparoscopic versus open appendicectomy for acute appendicitis: a prospective study. Ann Int Med Dent Res. 2021;7(2):4-8. doi:10.21276/aimdr.2021.7.2.SG2. 5. Niranjan AK, Kumar S. Prospective comparative study of laparoscopic appendectomy versus open appendectomy. Int J Pharm Clin Res. 2021;13(3):117-22. 6. Singh A, Sharma M, Abbas M. Laparoscopic versus open appendectomy: a comparative study. Int J Surg Sci. 2021;5(2):325-30. doi:10.33545/surgery.2021.v5.i2f.716. 7. Labricciosa FM, Sartelli M, Barbadoro P, Abbo LM, Ansaloni L, Coccolini F, et al. Epidemiology and risk factors for superficial surgical site infections after appendectomy for acute appendicitis: a secondary data analysis. Surg Infect (Larchmt). 2021;22(2):227-33. doi:10.1089/sur.2020.069. 8. Sayed AA, Abd El-Maksood IM, Mohammed RI. A comparative study of laparoscopic and open appendectomy. Med J Cairo Univ. 2021;89(1):155-61. doi:10.21608/mjcu.2021.153782. 9. Zeeshan M, Qayyum MS, Bashir R, Ahsan M, Saadi AR, Raza MA. Comparison of wound infection rate in open appendectomy (OA) vs laparoscopic appendectomy (LA). J Popul Ther Clin Pharmacol. 2024;31(6):688-93. doi:10.53555/jptcp.v31i6.6553. 10. Güler Y, Karabulut Z, Çaliş H, Şengül S. Comparison of laparoscopic and open appendectomy on wound infection and healing in complicated appendicitis. Int Wound J. 2020;17(4):957-65. doi:10.1111
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Frequency of Superficial Surgical Site Infections Between Laparoscopic Versus Open Appendectomy
- ClinicalTrials.gov ID
- NCT07841444
- Acronym / sponsor ID
- No.517/DME/QAMC Bahawalpur
- Conditions
- Acute Appendicitis, Superficial SSI
- Keywords
- Laparoscopic Appendectomy,, Open appendectomy,, Superficial Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
his randomized controlled trial was conducted to compare the frequency of superficial surgical site infections (SSIs) following laparoscopic appendectomy and open appendectomy in patients undergoing surgical treatment for acute appendicitis. The study was carried out in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over a period of six months from 24 January 2026 to 23 July 2026. A total of 276 patients were included in the study, with 138 participants allocated to each treatment group. Patients enrolled in the trial were assigned to one of two study groups according to the study protocol. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. The purpose of the comparison was to determine whether the operative approach was associated with a difference in the occurrence of superficial surgical site infection after appendectomy. The study therefore evaluated two established surgical approaches for the same clinical condition while maintaining a randomized comparative design.
The primary outcome of the study was the frequency of superficial surgical site infection after appendectomy. Superficial surgical site infection refers to infection involving the skin and subcutaneous tissue at the surgical incision. The occurrence of this postoperative complication was assessed in participants in both groups using the same outcome definition and follow-up approach specified in the study protocol. The frequency of superficial SSI was then compared between the laparoscopic and open appendectomy groups.
The study was designed as an interventional randomized controlled trial. Participants were assigned to an intervention group on the basis of the study protocol rather than simply being observed according to the treatment they would otherwise have received. The intervention under investigation was the operative approach: laparoscopic appendectomy versus open appendectomy. No investigational drug or biologic product was evaluated, and the study was not conducted under a U.S. Food and Drug Administration Investigational New Drug application. Likewise, the study did not investigate a U.S. FDA-regulated device as the intervention and was not conducted under an Investigational Device Exemption.
The study population consisted of patients undergoing appendectomy at the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur. Eligible participants were enrolled according to the predefined inclusion and exclusion criteria of the study protocol. Participants in the laparoscopic group received appendectomy through the laparoscopic approach, whereas participants in the open group received appendectomy through the conventional open approach. Perioperative care and postoperative assessment were conducted according to the institutional surgical protocol and the requirements of the study. Data were collected prospectively during the study period and were used to assess the postoperative outcome of interest. The incidence of superficial surgical site infection was recorded for participants in each treatment group. The results were subsequently compared between the two groups to determine the observed difference in the frequency of superficial SSI following laparoscopic versus open appendectomy. The analysis was based on the predefined study outcome and the randomized allocation of participants.
The trial was conducted in a hospital surgical setting and included a total sample of 276 participants, providing 138 participants in each group. The study was intended to generate comparative clinical evidence regarding superficial wound infection after the two operative approaches. By directly comparing laparoscopic and open appendectomy within a randomized controlled trial, the study provides a structured assessment of the postoperative wound-related outcome in the enrolled patient population.
The study was undertaken after institutional ethical oversight and approval in accordance with the applicable requirements. Written informed consent was obtained from participants before enrollment, as specified in the study protocol. Participant information was handled confidentially, and study procedures were conducted in accordance with the approved protocol and institutional requirements.
The trial compares superficial surgical site infection between patients undergoing laparoscopic and open appendectomy at the study center. Its focus is the wound outcome associated with the two surgical approaches
Detailed description
Acute appendicitis is one of the most common surgical emergencies and appendectomy remains one of the most frequently performed emergency abdominal surgical procedures. Open appendectomy has traditionally been used as the standard operative approach, while laparoscopic appendectomy has increasingly been adopted because of its minimally invasive nature and potential postoperative advantages. Surgical site infection is an important postoperative complication of appendectomy because it can cause additional morbidity, delay wound healing and recovery, increase the need for postoperative treatment and follow-up, and potentially prolong healthcare utilization. The frequency of surgical site infection may vary according to the operative approach, patient characteristics, disease severity, operative technique, and perioperative management.
The present randomized controlled trial was conducted to compare the frequency of superficial surgical site infections following laparoscopic appendectomy and open appendectomy in patients presenting with acute appendicitis. The study was conducted in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over six months, from 24 January 2026 to 23 July 2026. A total of 276 patients were included, with 138 participants allocated to each group.
The study population consisted of patients aged 15 to 60 years of either sex who presented with acute appendicitis and fulfilled the predefined eligibility criteria. Acute appendicitis was diagnosed on the basis of right iliac fossa pain with a visual analogue scale score of 3-10, positive rebound tenderness on clinical examination, and a white blood cell count greater than 10,000/mm³. Patients were eligible if the duration of symptoms was 48 hours or less. Both elective and emergency appendectomies were included.
Patients were excluded if they had generalized peritonitis, perforated appendicitis, uncontrolled diabetes mellitus, immunosuppression, previous abdominal surgery, chronic renal failure with serum creatinine above 1.5 mg/dL, or chronic liver disease with serum bilirubin above 2 mg/dL.
After approval of the study synopsis and institutional ethical approval, eligible patients were enrolled after obtaining informed written consent. Baseline demographic and clinical information was recorded using a structured data collection proforma. Variables included age, sex, duration of symptoms, height, weight, body mass index, obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery.
A body mass index greater than 27 kg/m² was considered obese and 27 kg/m² or below was considered non-obese. Residence was categorized as urban or rural according to documented residential address. Socioeconomic status was categorized according to monthly household income into poor class (≤20,000 PKR), middle class (21,000-40,000 PKR), and upper class (≥41,000 PKR). Diabetes mellitus was recorded on the basis of a known history of diabetes with ongoing treatment and controlled fasting blood glucose below 126 mg/dL on two consecutive measurements.
Participants were randomly allocated in a 1:1 ratio using a lottery method. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All participants received prophylactic antibiotics according to the study protocol, and the duration of postoperative intravenous and outpatient antibiotic therapy was recorded. All operations were performed by the same consultant surgeon with at least five years of post-fellowship experience to maintain consistency in operative technique.
Patients were followed for seven postoperative days. During follow-up, the surgical wound was assessed for superficial surgical site infection and findings were recorded on the structured proforma. The primary outcome was the frequency of superficial surgical site infection within seven postoperative days. Superficial SSI was defined according to the predefined clinical criteria. A patient was considered to have superficial SSI if purulent wound discharge, redness around the wound or stitches, or postoperative fever exceeding 100°F was observed within seven days following surgery. The outcome was recorded as present or absent.
Demographic and clinical characteristics were recorded for comparison between groups. These included age, sex, duration of symptoms, BMI and obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. Stratified analysis of superficial SSI was planned according to these characteristics.
The sample size was calculated using a 5% level of significance and 80% power, based on an anticipated superficial surgical site infection rate of 20% following laparoscopic appendectomy and 35% following open appendectomy. A total of 276 participants were included, with 138 in each group. Consecutive sampling was used for participant enrollment, followed by random allocation using the lottery method.
Operative duration was recorded for each participant and categorized into short and long duration according to the predefined study categorization for stratified analysis.
Statistical analysis was performed using SPSS version 25.0. Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables were expressed as mean ± standard deviation, while non-normally distributed variables were presented as median with interquartile range. Categorical variables were summarized using frequencies and percentages. The independent-samples t-test was used for normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. Categorical variables were compared using the Chi-square test or Fisher's exact test, as appropriate.
The primary outcome was compared between the laparoscopic and open appendectomy groups using the Chi-square test. Stratified analyses were performed according to age group, sex, duration of symptoms, BMI category, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. A p-value of ≤0.05 was considered statistically significant.
The study specifically focused on superficial SSI occurring during the first seven postoperative days and did not combine superficial infection with deep or organ/space surgical site infection. The study was conducted after institutional ethical approval and approval of the study synopsis. Written informed consent was obtained from all participants before enrollment. Participant demographic and clinical information was recorded using a structured proforma, and postoperative wound findings were documented during the seven-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial comparing laparoscopic appendectomy with open appendectomy in patients aged 15-60 years with acute appendicitis. A total of 276 eligible patients were randomly allocated in a 1:1 ratio using the lottery method, with 138 patients assigned to each group. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All procedures were performed by the same consultant surgeon. Patients were followed for 7 postoperative days to assess the occurrence of superficial surgical site infection. No participant crossed over between intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Appendectomy | Experimental | Procedure: Laparoscopic appendectomyParticipants assigned to this arm underwent laparoscopic appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F. |
| Open Appendectomy | Active comparator | Procedure: Open AppendectomyParticipants assigned to this arm underwent open appendectomy for acute appendicitis. A total of 138 patients were allocated to this group by 1:1 randomization using the lottery method. The procedure was performed by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days, and the occurrence of superficial surgical site infection was assessed based on predefined criteria, including purulent wound discharge, redness around the wound or stitches, or postoperative fever above 100°F. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged 15-60 years of either sex.
- Patients diagnosed with acute appendicitis according to the predefined operational definition and undergoing appendectomy.
- Duration of symptoms less than 48 hours.
- Both elective and emergency appendectomy cases.
Key exclusion criteria (5 listed)
- Patients with generalized peritonitis or perforated appendicitis.
- Patients with significant comorbidities, including uncontrolled diabetes mellitus or immunosuppression.
- Patients with a history of previous abdominal surgery.
- Patients with chronic renal failure, assessed on history and medical records, with serum creatinine >1.5 mg/dL.
- Patients with chronic liver disease, assessed on history and medical records, with serum bilirubin >2 mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomyLaparoscopic appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection. | Procedure or surgery | Laparoscopic Appendectomy |
| Open AppendectomyOpen appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection. | Procedure or surgery | Open Appendectomy |
Primary outcome
Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy
Time frame: Within 7 postoperative days after appendectomy.
The primary outcome is the occurrence of superficial surgical site infection within 7 postoperative days after appendectomy. SSI will be recorded as present if the patient develops purulent wound discharge, redness around the wound or stitches, or postoperative fever greater than 100°F during the follow-up period. The frequency of superficial SSI will be compared between the laparoscopic appendectomy and open appendectomy groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Results publication1. Ullah R, Shah M, Babar Y, Khan A. Comparison of laparoscopic and open appendectomy in terms of surgical site infection. Biol Clin Sci Res J. 2024;2024(1):696. doi:10.54112/bcsrj.v2024i1.696. 2. Khazaal AS. Laparoscopic vs open appendectomy: comparison on clinical outcome. World J Lap Surg. 2022;15(1):54-57. doi:10.5005/jp-journals-10033-1484. 3. Gu Q, Hua Y. Perforated appendicitis treated with laparoscopic appendicectomy or open appendicectomy: a meta-analysis. J Minim Access Surg. 2023;19(3):348-54. doi:10.4103/jmas.jmas_158_22. 4. Kumar M, Devkaran B, Verma DK, Mahajan P, Sharma VK, Galodha S. Comparative study of laparoscopic versus open appendicectomy for acute appendicitis: a prospective study. Ann Int Med Dent Res. 2021;7(2):4-8. doi:10.21276/aimdr.2021.7.2.SG2. 5. Niranjan AK, Kumar S. Prospective comparative study of laparoscopic appendectomy versus open appendectomy. Int J Pharm Clin Res. 2021;13(3):117-22. 6. Singh A, Sharma M, Abbas M. Laparoscopic versus open appendectomy: a comparative study. Int J Surg Sci. 2021;5(2):325-30. doi:10.33545/surgery.2021.v5.i2f.716. 7. Labricciosa FM, Sartelli M, Barbadoro P, Abbo LM, Ansaloni L, Coccolini F, et al. Epidemiology and risk factors for superficial surgical site infections after appendectomy for acute appendicitis: a secondary data analysis. Surg Infect (Larchmt). 2021;22(2):227-33. doi:10.1089/sur.2020.069. 8. Sayed AA, Abd El-Maksood IM, Mohammed RI. A comparative study of laparoscopic and open appendectomy. Med J Cairo Univ. 2021;89(1):155-61. doi:10.21608/mjcu.2021.153782. 9. Zeeshan M, Qayyum MS, Bashir R, Ahsan M, Saadi AR, Raza MA. Comparison of wound infection rate in open appendectomy (OA) vs laparoscopic appendectomy (LA). J Popul Ther Clin Pharmacol. 2024;31(6):688-93. doi:10.53555/jptcp.v31i6.6553. 10. Güler Y, Karabulut Z, Çaliş H, Şengül S. Comparison of laparoscopic and open appendectomy on wound infection and healing in complicated appendicitis. Int Wound J. 2020;17(4):957-65. doi:10.1111
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study data contain participant-level information and will be retained by the research team in accordance with institutional policies and ethical requirements. Only aggregated, anonymized results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic appendectomy and Open Appendectomy in people with Acute Appendicitis and Superficial SSI, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy (time frame: Within 7 postoperative days after appendectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07841444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.