Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy

NCT ID: NCT07103707

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Wound Infection, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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open cholecystectomy

patient undergoing open cholecystectomy

Group Type ACTIVE_COMPARATOR

open cholecystectomy

Intervention Type PROCEDURE

standard open cholecystectomy performed under general anesthesia

laparoscopic cholecystectomy

patient undergoing laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Standard laparoscopic cholecystectomy using minimally invasive technique

Interventions

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open cholecystectomy

standard open cholecystectomy performed under general anesthesia

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Standard laparoscopic cholecystectomy using minimally invasive technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Both genders

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

Exclusion Criteria

* ● 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lady Reading Hospital, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Moeez u din Khan

surgical resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad faraz, AP GS(FCPS)

Role: PRINCIPAL_INVESTIGATOR

Lady reading hospital peshawar

Locations

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Moeez u din khan

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Moeez u din khan, PGR GS

Role: CONTACT

+923489548857

IJAZ UL HAQUE, PGR NS

Role: CONTACT

+923499223911

Facility Contacts

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Moeez u din khan, PGR GS

Role: primary

03489548857

IJAZ UL HAQUE, PGR NSG

Role: backup

+923499223911

Other Identifiers

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253/LRH/MTI

Identifier Type: -

Identifier Source: org_study_id

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