Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy

NCT07103707 | Recruiting DMC

• 1 other identifier: 253/LRH/MTI
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the frequency of wound infection between open and laparoscopic cholecystectomy in adult patient aged 18- 65 years with symptomatic cholelithiasis admitted through OPD the main question it aims to answer are

• Does there is difference in the frequency of wound infection in patients with open cholecystectomy as compared to laparoscopic cholecystectomy Researcher will compare the frequency of wound infection in participant undergoing open and laparoscopic cholecystectomy to see there is difference in frequency of wound infection between open and laparoscopic cholecystectomy Participants will be asked
• To Visit OPD after 1 week for follow up
• Keep record of symptoms like erythema, pain, cloudy drainage from the incision site

Conditions

Wound Infection, Surgical

Outcome Measures

Primary Outcomes (1)

• comparison of frequency of wound infection between open and laparoscopic cholecystectomy

  to compare the frequency of wound infection in patients undergoing open and laparoscopic

  1 year

Study Arms (2)

open cholecystectomy

ACTIVE COMPARATOR

patient undergoing open cholecystectomy

Procedure: open cholecystectomy

laparoscopic cholecystectomy

ACTIVE COMPARATOR

patient undergoing laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Interventions

open cholecystectomy PROCEDURE

standard open cholecystectomy performed under general anesthesia

open cholecystectomy

Laparoscopic cholecystectomy PROCEDURE

Standard laparoscopic cholecystectomy using minimally invasive technique

laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• Patients aged 18 to 65 years
• Symptomatic cholelithiasis as per operational definition
• Undergoing cholecystectomy (open/laparoscopic)
• ASA score I/II (Annexure-II)

You may not qualify if:

• ● H/o diabetes mellitus
• H/o immunocompromised state (e.g. HIV, steroid use)
• H/o acute cholecystitis
• H/o empyema gallbladder
• H/o gallbladder perforation ● H/o choledocholithiasis
• H/o portal hypertension
• H/o abnormal blood clotting profiles (PTT \>15 seconds, APTT \>20 seconds)
• H/o pregnancy on HCG

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead

Study Sites (1)

Moeez u din khan

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Ahmad faraz, AP GS(FCPS)

  Lady reading hospital peshawar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moeez u din khan, PGR GS

CONTACT

+923489548857; moeezk442@gmail.com

IJAZ UL HAQUE, PGR NS

CONTACT

+923499223911; drijazulhaque712237@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: surgical resident

Model Details: randomization will performed by blocked randomization (61 in each group) 61 patient will be in open cholecystectomy group( A )while 61 patient will be in laparoscopic cholecystectomy group (B)

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)