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

Pain, Postoperative Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738710
• Other study ID #: MTU-EC-SU-1-042/59
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: March 28, 2018
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: March 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gallstone
• Gallstones
• Pain, Postoperative

Intervention

Procedure:
• transumbilical incision
incision within umbilicus
• Infra umbilical incision
incision about 1 cm below umbilicus

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Khlong Luang	Pathumtani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	visual analog scale (0-10)	7 days postoperatively
Secondary	wound infection	yes or no according to Center for Disease Control and Prevention (CDC) criteria	at 1 week and 1 month postoperatively
Secondary	patient satisfaction	Visual analog scale (0-10)	1 week and 3 months postoperatively