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

Not Applicable

Completed

• Conditions: Gallstone; Pain, Postoperative
• Interventions: Procedure: Infra umbilical incision; Procedure: transumbilical incision

• Registration Number: NCT02738710
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-10
• Study First Posted: 2016-04-14
• Study Start: 2016-09
• Primary Completion: 2017-09
• Study Completion: 2017-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infra umbilical wound	Infra umbilical incision	infra umbilical incision
transumbilical wound	transumbilical incision	transumbilical incision

Primary Outcome Measures

Name	Time	Method
Postoperative pain	7 days postoperatively	visual analog scale (0-10)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Khlong Luang, Pathumtani, Thailand