Laparoscopic vs Open Appendectomy in Obese Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-50
SponsorUniversity of Health Sciences Lahore
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Open Appendectomy
Procedure/SurgeryOpen surgical removal of the appendix performed via a standard grid-iron incision under general anesthesia with standard prophylactic antibiotics.
Laparoscopic Appendectomy
Procedure/SurgeryLaparoscopic 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.
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Open AppendectomyActive comparator 1 intervention
Group B: Group 2: Laparoscopic AppendectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Up to 30 days postoperatively2
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).
Time frame
From day of surgery up to discharge (up to 30 days postoperatively)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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