Laparoscopic vs Open Appendectomy in Obese Patients

N/ANot Yet RecruitingNCT07822503

University of Health Sciences Lahore166 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

166

Conditions

Acute Appendicitis Appendicitis (Diagnosis)Obesity

Interventions

Open AppendectomyPROCEDURE

Open surgical removal of the appendix performed via a standard grid-iron incision under general anesthesia with standard prophylactic antibiotics.

Laparoscopic AppendectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Obese patients with Body Mass Index (BMI) ≥ 30 kg/m². 2. 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). 3. Age between 15 and 50 years. 4. Both male and female patients. Exclusion Criteria: 1. Immunocompromised patients (e.g., HIV infection or current steroid therapy). 2. History of prior chemotherapy, radiotherapy, or recurrent infections. 3. History of drug or alcohol abuse. 4. Severe hepatic, renal, or cardiovascular dysfunction. 5. History of previous abdominal surgery. 6. Appendicular malignancy. 7. Pregnant women. 8. Preoperative findings indicating appendiceal perforation.

Outcomes

Primary Outcomes

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 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).

Time frame: From day of surgery up to discharge (up to 30 days postoperatively)