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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Department of Surgery

    Bahawalpur, Punjab Province, 63100

Other trials in Pakistan

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.

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 groups in NCT07841444
Study groupRoleWhat they receive
Laparoscopic AppendectomyExperimentalParticipants 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 AppendectomyActive comparatorParticipants 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.

  1. 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.

  1. First posted25 Sep 2026
  2. Study start24 Jan 2026
  3. Primary completion23 Jul 2026
  4. Study completion23 Jul 2026

Resources

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)
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

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.

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