Acute AppendicitisNCT07822503
Laparoscopic vs Open Appendectomy in Obese Patients
A study testing Open Appendectomy and Laparoscopic Appendectomy in people with Acute Appendicitis and Appendicitis (Diagnosis), run by University of Health Sciences Lahore.
Trial summary
Acute appendicitis is one of the most common surgical emergencies globally. While surgical removal of the appendix (appendectomy) is the definitive treatment, the optimal surgical approach-laparoscopic versus open-remains widely debated, particularly in obese patients. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Acute Appendicitis, Appendicitis (Diagnosis), Obesity
- What is being tested?
- Open Appendectomy and Laparoscopic Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese patients with Body Mass Index (BMI) ≥ 30 kg/m².
- Clinical diagnosis of acute appendicitis based on Alvarado score (history of right lower quadrant or periumbilical pain shifting to RLQ, nausea and/or vomiting, fever > 38 °C, RLQ guarding and tenderness, and/or leukocytosis > 10,000 cells/mL).
- Age between 15 and 50 years.
- Both male and female patients.
Who cannot join
- Immunocompromised patients (e.g., HIV infection or current steroid therapy).
- History of prior chemotherapy, radiotherapy, or recurrent infections.
- History of drug or alcohol abuse.
- Severe hepatic, renal, or cardiovascular dysfunction.
- History of previous abdominal surgery.
- Appendicular malignancy.
- Pregnant women.
- Preoperative findings indicating appendiceal perforation.
About this study
Official title: Evaluation of Post Operative Outcomes of Laparoscopic and Open Appendectomy in Obese Patients
Acute appendicitis is one of the most common surgical emergencies globally. While surgical removal of the appendix (appendectomy) is the definitive treatment, the optimal surgical approach-laparoscopic versus open-remains widely debated, particularly in obese patients. Obese individuals present unique surgical challenges due to increased abdominal wall thickness, which often necessitates larger skin incisions during open procedures, potentially increasing postoperative pain, wound healing times, and wound complications.
This study aims to compare the postoperative outcomes of laparoscopic appendectomy versus standard open appendectomy in obese patients (BMI ≥ 30 kg/m²) presenting with acute appendicitis. Participants will be randomly assigned to undergo either open appendectomy or laparoscopic appendectomy. The primary outcomes evaluated will be the incidence of surgical site infections (including superficial wound infections and intra-abdominal abscesses) up to 30 days post-procedure and the total length of hospital stay (in days).
- Conditions
- Acute Appendicitis, Appendicitis (Diagnosis), Obesity
- Being tested
- Open Appendectomy, Laparoscopic Appendectomy
- Medical subject headings
- Appendicitis, Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open AppendectomyProcedure or surgery
Open surgical removal of the appendix performed via a standard grid-iron incision under general anesthesia with standard prophylactic antibiotics.
Laparoscopic AppendectomyProcedure or surgery
Laparoscopic surgical removal of the appendix using a standard 3-port configuration (umbilical, left iliac fossa, and lower midline ports) under general anesthesia with standard prophylactic antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Open Appendectomy | Active comparator | Participants undergo open appendectomy using a standard grid-iron incision under general anesthesia. Appendiceal base ligation and closure are performed in standard anatomical layers. Receives: Procedure: Open Appendectomy |
| Group 2: Laparoscopic Appendectomy | Experimental | Participants undergo laparoscopic appendectomy using a standard 3-port technique (umbilical, left iliac fossa, and lower midline ports) under general anesthesia. Receives: Procedure: Laparoscopic Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI)
Proportion of patients who develop a surgical site infection, defined as either superficial/deep wound infection (presence of purulent discharge, erythema, localized swelling, or requiring reopening) or intra-abdominal abscess (confirmed via ultrasound in patients presenting with abdominal pain, fever, or fullness)
Measured: Up to 30 days postoperatively
Length of Hospital Stay
The total number of days the patient remained in the hospital postoperatively until meeting discharge criteria (afebrile, tolerating a regular diet, and achieving good pain control).
Measured: From day of surgery up to discharge (up to 30 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start2 Oct 2026 (estimated)
- Primary completion2 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saira Khan, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822503
- Sponsor's protocol ID
- Exp134
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Outcomes of Laparoscopic and Open Appendectomy in Obese Patients
- ClinicalTrials.gov ID
- NCT07822503
- Acronym / sponsor ID
- Exp134
- Conditions
- Acute Appendicitis, Appendicitis (Diagnosis), Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 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.
Acute appendicitis is one of the most common surgical emergencies globally. While surgical removal of the appendix (appendectomy) is the definitive treatment, the optimal surgical approach-laparoscopic versus open-remains widely debated, particularly in obese patients. Obese individuals present unique surgical challenges due to increased abdominal wall thickness, which often necessitates larger skin incisions during open procedures, potentially increasing postoperative pain, wound healing times, and wound complications.
This study aims to compare the postoperative outcomes of laparoscopic appendectomy versus standard open appendectomy in obese patients (BMI ≥ 30 kg/m²) presenting with acute appendicitis. Participants will be randomly assigned to undergo either open appendectomy or laparoscopic appendectomy. The primary outcomes evaluated will be the incidence of surgical site infections (including superficial wound infections and intra-abdominal abscesses) up to 30 days post-procedure and the total length of hospital stay (in days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Appendectomy | Active comparator | Procedure: Open AppendectomyParticipants undergo open appendectomy using a standard grid-iron incision under general anesthesia. Appendiceal base ligation and closure are performed in standard anatomical layers. |
| Group 2: Laparoscopic Appendectomy | Experimental | Procedure: Laparoscopic AppendectomyParticipants undergo laparoscopic appendectomy using a standard 3-port technique (umbilical, left iliac fossa, and lower midline ports) under general anesthesia. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Obese patients with Body Mass Index (BMI) ≥ 30 kg/m².
- Clinical diagnosis of acute appendicitis based on Alvarado score (history of right lower quadrant or periumbilical pain shifting to RLQ, nausea and/or vomiting, fever > 38 °C, RLQ guarding and tenderness, and/or leukocytosis > 10,000 cells/mL).
- Age between 15 and 50 years.
- Both male and female patients.
Key exclusion criteria (8 listed)
- Immunocompromised patients (e.g., HIV infection or current steroid therapy).
- History of prior chemotherapy, radiotherapy, or recurrent infections.
- History of drug or alcohol abuse.
- Severe hepatic, renal, or cardiovascular dysfunction.
- History of previous abdominal surgery.
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 |
|---|---|---|
| Open AppendectomyOpen surgical removal of the appendix performed via a standard grid-iron incision under general anesthesia with standard prophylactic antibiotics. | Procedure or surgery | Open Appendectomy |
| Laparoscopic AppendectomyLaparoscopic surgical removal of the appendix using a standard 3-port configuration (umbilical, left iliac fossa, and lower midline ports) under general anesthesia with standard prophylactic antibiotics. | Procedure or surgery | Group 2: Laparoscopic Appendectomy |
Primary outcome
Incidence of Surgical Site Infection (SSI)
Time frame: Up to 30 days postoperatively
Proportion of patients who develop a surgical site infection, defined as either superficial/deep wound infection (presence of purulent discharge, erythema, localized swelling, or requiring reopening) or intra-abdominal abscess (confirmed via ultrasound in patients presenting with abdominal pain, fever, or fullness)
Length of Hospital Stay
Time frame: From day of surgery up to discharge (up to 30 days postoperatively)
The total number of days the patient remained in the hospital postoperatively until meeting discharge criteria (afebrile, tolerating a regular diet, and achieving good pain control).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Open Appendectomy and Laparoscopic Appendectomy in people with Acute Appendicitis and Appendicitis (Diagnosis), run by University of Health Sciences Lahore.
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 8 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Surgical Site Infection (SSI) (time frame: Up to 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.