Port site problems in laparoscopic cholecystectomy

Not Applicable

Completed

• Conditions: Health Condition 1: K801- Calculus of gallbladder with othercholecystitisHealth Condition 2: K801- Calculus of gallbladder with othercholecystitisHealth Condition 3: K801- Calculus of gallbladder with othercholecystitisHealth Condition 4: K801- Calculus of gallbladder with othercholecystitisHealth Condition 5: K801- Calculus of gallbladder with othercholecystitis

• Registration Number: CTRI/2021/10/037123
• Lead Sponsor: All India Institute of Medical Sciences Patna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-31
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

Patients with symptomatic gallstone disease undergoing an elective standard 4-port laparoscopic cholecystectomy with: -

i)Age between 18-80 years

ii)American Society of Anesthesiologists (ASA) grade 1

and 2

iii)Consenting to participate

iv)Not a part of any other trial or research project

Exclusion Criteria

i)Patients in whom laparoscopic cholecystectomy will be converted into an open procedure

ii)Suspicion of gallbladder malignancy in pre-operative imaging modality

iii)BMI > 30kg/m2

iv)Immunocompromised and diabetic patients

v)Perforation of gallbladder â?? intra-abdominal or during its extraction

vi)Bile spillage

vii)Any stone > 2cm in size in pre-operative imaging

viii)Empyema of the gallbladder â?? pre-op imaging or intra-op

ix)Patients undergoing some other abdominal surgery in the follow-up period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the post-operative pain score by VAS (Visual analogue scale) after gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.Timepoint: To determine the post-operative pain score by VAS (Visual analogue scale) at 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, 7 days and 30 days after gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.

Secondary Outcome Measures

Name	Time	Method
To determine the incidence of Surgical site infection (SSI), incidence of port site herniation and time for gallbladder extraction via umbilical or epigastric ports in patients undergoing an elective standard 4-port laparoscopic cholecystectomy for symptomatic gallstone disease.Timepoint: SSI- 7days, 30 days <br/ ><br>Port site herniation- 1 month, 3 months <br/ ><br>Time for gallbladder extraction- in minutes from gallbladder dissected off the gallbladder fossa till its actual extraction out of the abdominal cavity