To compare the results of gall bladder retrieval from two different ports in laparoscopic cholecystectomy

Recruiting

Conditions: Calculus of gallbladder without cholecystitis,

Registration Number: CTRI/2019/02/017615

Lead Sponsor: Armed Forces Medical College

Brief Summary: Laparoscopic Cholecystectomy is one of the most common procedures performed by general surgeons. However, there have been no studies in our setting to evaluate the umbilical vs epigastric port site gall bladder extraction and its relation to post-operative pain as well as other complications related to port site. Despite a lot of literature available on laparoscopic cholecystectomy, still it is not clear which port site is best to extract gall bladder. This current study aims to explore a better port for gallbladder retrieval in laparoscopic cholecystectomy in terms of pain outcome, time taken for delivery of gall bladder out of abdomen and ease of extraction by randomized controlled trial study to be conducted at our tertiary care teaching hospital.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 50

Inclusion Criteria

16-80 years old patients undergoing elective laparoscopic cholecystectomy for benign GB diseases (symptomatic gallstones, GB polyps) Patients in whom informed consent could be obtained.

Exclusion Criteria

Acute cholecystitis Empyema GB Mucocele of GB, Suspected/proven malignancy of GB Patients in whom laparoscopic cholecystectomy has to be converted in open procedure Patients who are chronic users of analgesic medicines and steroids.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the post operative pain at the port site in both groups	Pain score will be graded by the patient with VAS score (0-10) at 6 hours, 12 hours, 24 hours and 48 hours following surgery

Secondary Outcome Measures

Name	Time	Method
To assess the ease of retrieval of gall bladder	The difficulty in GB retrieval will be graded by the operative surgeon by using VAS score (0- easy retrieval, 10- very difficult retrieval)
To assess the time taken for retrieval of gall bladder following dissection from liver bed	The time taken for removal of the gall bladder following dissection to retrieval in minutes
To assess the incidence of port site infection	Port site infection to be graded by South Hampton wound scoring system on day 7, 14 and 06 weeks following surgery

Trial Locations

Locations (1): Command Hosp, Southern Command
🇮🇳
Pune, MAHARASHTRA, India
Command Hosp, Southern Command
🇮🇳Pune, MAHARASHTRA, India
Dronacharya Routh
Principal investigator
9464667808
drona_routh@yahoo.co.in

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