Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy

NCT07103707 — Not applicable, Recruiting, 122 participants, Lady Reading Hospital, Pakistan

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Registry	NCT07103707
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, other
Enrollment	122 (Estimated)
Sponsor	Lady Reading Hospital, Pakistan (Other gov)
Conditions	Wound Infection, Surgical
Interventions	open cholecystectomy, Laparoscopic cholecystectomy (Procedure)
Dates	start 2025-08-01 (estimated), primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-08-05, last updated 2025-08-05
Locations	1 site in Pakistan

-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

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+Arms and interventions

Arm	Type	Interventions	Description
open cholecystectomy	Active comparator	Procedure: open cholecystectomy	patient undergoing open cholecystectomy
laparoscopic cholecystectomy	Active comparator	Procedure: Laparoscopic cholecystectomy	patient undergoing laparoscopic cholecystectomy

open cholecystectomy (Procedure): standard open cholecystectomy performed under general anesthesia
Laparoscopic cholecystectomy (Procedure): Standard laparoscopic cholecystectomy using minimally invasive technique

+Outcome measures

Primary outcomes

comparison of frequency of wound infection between open and laparoscopic cholecystectomy [1 year]: to compare the frequency of wound infection in patients undergoing open and laparoscopic

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Moeez u din khan	Peshawar, Khyber Pakhtunkhwa	Pakistan	Recruiting

+Investigators

Ahmad faraz, AP GS(FCPS), Principal investigator, Lady reading hospital peshawar