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

Primary Purpose

Pain, Postoperative, Gallstone

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

transumbilical incision

Infra umbilical incision

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Thammasat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transumbilical wound

infra umbilical wound

Arm Description

transumbilical incision

infra umbilical incision

Outcomes

Primary Outcome Measures

Postoperative pain

visual analog scale (0-10)

Secondary Outcome Measures

wound infection

yes or no according to Center for Disease Control and Prevention (CDC) criteria

patient satisfaction

Visual analog scale (0-10)

Full Information

NCT ID

NCT02738710

First Posted

April 5, 2016

Last Updated

March 28, 2018

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT02738710

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Gallstone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

transumbilical wound

Arm Type

Experimental

Arm Description

transumbilical incision

Arm Title

infra umbilical wound

Arm Type

Active Comparator

Arm Description

infra umbilical incision

Intervention Type

Procedure

Intervention Name(s)

transumbilical incision

Intervention Description

incision within umbilicus

Intervention Type

Procedure

Intervention Name(s)

Infra umbilical incision

Intervention Description

incision about 1 cm below umbilicus

Primary Outcome Measure Information:

Title

Postoperative pain

Description

visual analog scale (0-10)

Time Frame

7 days postoperatively

Secondary Outcome Measure Information:

Title

wound infection

Description

yes or no according to Center for Disease Control and Prevention (CDC) criteria

Time Frame

at 1 week and 1 month postoperatively

Title

patient satisfaction

Description

Visual analog scale (0-10)

Time Frame

1 week and 3 months postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trilak Chunsurisap

Organizational Affiliation

Thammasat University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Thammasat University Hospital

City

Khlong Luang

State/Province

Pathumtani

ZIP/Postal Code

12120

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30350096

Citation

Siribumrungwong B, Chunsirisub T, Limpavitayaporn P, Tongyoo A, Sriussadaporn E, Mingmalairak C, Thowprasert W, Thakkinstian A. Comparison of postoperative pain at umbilical wound after conventional laparoscopic cholecystectomy between transumbilical and infraumbilical incisions: a randomized control trial. Surg Endosc. 2019 May;33(5):1578-1584. doi: 10.1007/s00464-018-6447-y. Epub 2018 Oct 22.

Results Reference

derived

Learn more about this trial

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

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