NCT04208568

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 16, 2019

Last Update Submit

December 20, 2019

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Gallbladder retrieval from umbilical port

ACTIVE COMPARATOR

Gallbladder retrieved from 10 mm umbilical port.

Procedure: Laparoscopic cholecystectomy

Gallbladder retrieval from epigastric port

ACTIVE COMPARATOR

Gallbladder retrieved from 10 mm epigastric port.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Four ports laparoscopic cholecystectomy under general anaesthesia

Gallbladder retrieval from epigastric portGallbladder retrieval from umbilical port

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All healthy patients without cholecystitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 23, 2019

Study Start

January 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share