Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional prevention trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- All healthy patients without cholecystitis
Exclusion Criteria:
- Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gallbladder retrieval from umbilical port
Gallbladder retrieval from epigastric port
Arm Description
Gallbladder retrieved from 10 mm umbilical port.
Gallbladder retrieved from 10 mm epigastric port.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04208568
First Posted
December 16, 2019
Last Updated
December 20, 2019
Sponsor
Baqai Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04208568
Brief Title
Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baqai Medical University
4. Oversight
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
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gallbladder retrieval from umbilical port
Arm Type
Active Comparator
Arm Description
Gallbladder retrieved from 10 mm umbilical port.
Arm Title
Gallbladder retrieval from epigastric port
Arm Type
Active Comparator
Arm Description
Gallbladder retrieved from 10 mm epigastric port.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Four ports laparoscopic cholecystectomy under general anaesthesia
Primary Outcome Measure Information:
Title
comparison of postoperative pain after laparoscopic cholecystectomy between umbilical and epigastric port sites, using Numerical Analogue Scale (NAS).
Description
Numerical Analogue Scale (NAS) was used to measure the pain score.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All healthy patients without cholecystitis
Exclusion Criteria:
Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.
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