Comparison of Frequency of Wound Infection Between Open and Laparoscopic Cholecystectomy

Lady Reading Hospital, Pakistan

Status: Enrolling

Conditions: Wound Infection, Surgical

Treatments: Procedure: open cholecystectomy; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07103707

253/LRH/MTI

Details and patient eligibility

About

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

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

open cholecystectomy

Active Comparator group

Description:

patient undergoing open cholecystectomy

Treatment:

Procedure: open cholecystectomy

laparoscopic cholecystectomy

Active Comparator group

Description:

patient undergoing laparoscopic cholecystectomy

Treatment:

Procedure: Laparoscopic cholecystectomy