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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholelithiasis
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All healthy patients without cholecystitis

Exclusion Criteria:

• Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baqai Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Pain, Postoperative; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Muhammad Danish Muneeb

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No