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

NCT ID: NCT04208568

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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).

Conditions

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Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Gallbladder retrieval from umbilical port

Gallbladder retrieved from 10 mm umbilical port.

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Four ports laparoscopic cholecystectomy under general anaesthesia

Gallbladder retrieval from epigastric port

Gallbladder retrieved from 10 mm epigastric port.

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Four ports laparoscopic cholecystectomy under general anaesthesia

Interventions

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Laparoscopic cholecystectomy

Four ports laparoscopic cholecystectomy under general anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All healthy patients without cholecystitis

Exclusion Criteria

* Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baqai Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Muhammad Danish Muneeb

Identifier Type: -

Identifier Source: org_study_id