Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial

Not Applicable

Completed

• Conditions: Surgical Wound; Patient Satisfaction; Incision; General Surgery
• Interventions: Procedure: Subumbilical incision; Procedure: Transumbilical incision

• Registration Number: NCT03026400
• Lead Sponsor: Université de Sherbrooke

Brief Summary

While some studies have suggested that subumbilical and transumbilical incisions have a similar clinical efficiency and safety, no study has yet evaluated their respective impact on patient's postoperative aesthetic satisfaction.

The objective of this randomised trial is to compare patient's postoperative aesthetic satisfaction depending on the type of incision which is performed during surgeries.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-10
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Completion: 2017-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients 18-70 years old having a planned laparoscopic surgery with an umbilical first trocar at CHUS were included.

Exclusion Criteria

• Patients with a BMI > 40 or that had previous abdominal surgeries involving the umbilicus were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subumbilical incision	Subumbilical incision	The subumbilical incision was standardised. A curvilinear horizontal incision was performed to be able to reach the base of the umbilicus. The aponeurosis was incised with a scalpel and the peritoneal layer was open with a Kelly clamp. The incision was completed with the Hasson technique and a X-stitch was used for closure.
Transumbilical incision	Transumbilical incision	The transumbilical incision was also standardised, inverting the umbilicus with graspers, then incising vertically the skin to reach the umbilical physiological hernia to enlarge it. The incision was also completed with the Hasson technique and a X-stitch was used for closure.

Primary Outcome Measures

Name	Time	Method
Change in postoperative patient's aesthetic satisfaction	6 months	An inverted 10 points Wong-Baker facial grimace-type scale was used to assess patient's satisfaction. Although the french version of our questionnaire was not validated, the concept behind Wong-Baker facial scale have been in various studies. In the case of this study, a 10 point score was associated with the highest possible satisfaction regarding the aesthetic appearance of the umbilicus.; Patient's aesthetic satisfaction regarding the umbilicus was recorded preoperatively (right before the surgery), 1 month post-op and 6 months post-op. The change in postoperative patient's aesthetic satisfaction was assessed between pre-op vs 1 month post-op, pre-op vs 6 months post-op and 1 month vs 6 months post-op.

Secondary Outcome Measures

Name	Time	Method
Level of patient's awareness regarding the aesthetic appearance of the umbilicus	Pre-operative	YES/NO (no meaning that the patient gives little to no importance to the aesthetic appearance of the umbilicus).; Patient's level of importance regarding the aesthetic appearance of the umbilicus was recorded preoperatively (right before the surgery).

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada