Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.

Study Overview
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Brief Summary
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To know the association of postoperative pain after gallbladder removal from umbilical port site versus epigastric portsite, after four ports laparoscopic cholecystectomy,and the epigastric port site was found to be friendly for the patients in terms of less pain after gallbladder removal from this site after surgery.

Detailed Description
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Objective: To know the association of postoperative pain after gallbladder removal from umbilical port site versus epigastric port site, after four ports laparoscopic cholecystectomy. Randomized controlled trial was performed during 1-year period from January 2017 till January 2018, at a private hospital setup. Both male and female patients, with age group 18 and above, in years, were considered, who were planned four ports laparoscopic cholecystectomy after typical cholelithiasis. Those patients with polyps , mucocele or empyema in gallbladder or perforated gallbladder requiring emergency surgery were omitted from the study. The patients were randomly selected, 65 in which gallbladder was removed from umbilical region (group A) and 65 from epigastric region (group B) respectively. Determination of postoperative pain was done on day one, at the time of release from the hospital and at follow-up time one-month post-surgery, with the help of Numerical Analogue Scale (NAS).

Official Title
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Gallbladder Counting on Epigastric Site;A Randomized Trial Comparing Postoperative Pain After Gallbladder Retrieval From Umblical and Epigastric Port Site in Laproscopic Cholecystectomy

Conditions
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Cholelithiasis

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All healthy patients without cholecystitis Exclusion Criteria: Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gallbladder retrieval from umbilical port<br>Gallbladder retrieved from 10 mm umbilical port. | Procedure: Laparoscopic cholecystectomy<br>* Four ports laparoscopic cholecystectomy under general anaesthesia<br>|
| Active Comparator: Gallbladder retrieval from epigastric port<br>Gallbladder retrieved from 10 mm epigastric port. | Procedure: Laparoscopic cholecystectomy<br>* Four ports laparoscopic cholecystectomy under general anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of postoperative pain after laparoscopic cholecystectomy between umbilical and epigastric port sites, using Numerical Analogue Scale (NAS). | Numerical Analogue Scale (NAS) was used to measure the pain score. | 1 year |