Laparoscopic vs Open Appendectomy in Obese Patients

NCT07822503 | Not Yet Recruiting

• 1 other identifier: Exp134
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Appendicitis (Diagnosis); Obesity; Acute Appendicitis

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

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

Study Arms (2)

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.

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.

Procedure: Laparoscopic Appendectomy

Interventions

Open Appendectomy PROCEDURE

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

Open Appendectomy

Laparoscopic Appendectomy PROCEDURE

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.

Group 2: Laparoscopic Appendectomy

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Appendicitis; Disease; Obesity

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 16, 2026
• Study Start: October 2, 2026
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09