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NCT04208568 Clinical Trial

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

Cholelithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04208568
Other study ID # Muhammad Danish Muneeb
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 31, 2018

Study information
Verified date December 2019
Source Baqai Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- All healthy patients without cholecystitis

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic cholecystectomy
Four ports laparoscopic cholecystectomy under general anaesthesia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Baqai Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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