Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision

March 28, 2018 updated by: Boonying Siribumrungwong, Thammasat University
This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumtani
      • Khlong Luang, Pathumtani, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective laparoscopic cholecystectomy
  • willing to participate

Exclusion Criteria:

  • pregnancy
  • immunocompromised host
  • on continuous ambulatory peritoneal dialysis
  • morbid obesity (Body mass index > 35 kg/m2)
  • End-stage renal disease with hemodialysis dependent
  • ascites
  • uncontrolled coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transumbilical wound
transumbilical incision
Procedure: transumbilical incision
incision within umbilicus
Active Comparator: infra umbilical wound
infra umbilical incision
Procedure: Infra umbilical incision
incision about 1 cm below umbilicus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 7 days postoperatively
visual analog scale (0-10)
7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound infection
Time Frame: at 1 week and 1 month postoperatively
yes or no according to Center for Disease Control and Prevention (CDC) criteria
at 1 week and 1 month postoperatively
patient satisfaction
Time Frame: 1 week and 3 months postoperatively
Visual analog scale (0-10)
1 week and 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Study Chair: Trilak Chunsurisap, Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 10, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-SU-1-042/59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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