CClinicalTrials.gg
CompletedNCT04208568Updated Dec 23, 2019

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

An interventional study of Laparoscopic cholecystectomy in Cholelithiasis, sponsored by Baqai Medical University. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-23.

Sponsored by Baqai Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 130 is above the median of 90 across 197 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

This is the only study on the registry with Baqai Medical University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • All healthy patients without cholecystitis

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Gallbladder retrieval from umbilical port

    Gallbladder retrieved from 10 mm umbilical port.

    Procedure: Laparoscopic cholecystectomy

  • Active comparator
    Gallbladder retrieval from epigastric port

    Gallbladder retrieved from 10 mm epigastric port.

    Procedure: Laparoscopic cholecystectomy

Interventions

  • ProcedureLaparoscopic cholecystectomy

    Four ports laparoscopic cholecystectomy under general anaesthesia

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04208568
Lead sponsor
Baqai Medical University
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
Jan 1, 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Last update
Dec 23, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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