Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208568
Recruitment Status : Completed
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Baqai Medical University

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Laparoscopic cholecystectomy Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

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




Primary Outcome Measures :
  1. comparison of postoperative pain after laparoscopic cholecystectomy between umbilical and epigastric port sites, using Numerical Analogue Scale (NAS). [ Time Frame: 1 year ]
    Numerical Analogue Scale (NAS) was used to measure the pain score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All healthy patients without cholecystitis

Exclusion Criteria:

  • Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
Layout table for additonal information
Responsible Party: Baqai Medical University
ClinicalTrials.gov Identifier: NCT04208568    
Other Study ID Numbers: Muhammad Danish Muneeb
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholelithiasis
Cholecystolithiasis
Gallstones
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical