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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
Baqai Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 16, 2019
    Last Updated
    December 20, 2019
    Sponsor
    Baqai Medical University
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    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

    Learn more about this trial

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

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