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

NCT03026400 | Completed DMC

• 1 other identifier: 2014-688
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Surgical Wound; Incision; General Surgery

Outcome Measures

Primary Outcomes (1)

• Change in postoperative patient's aesthetic satisfaction

  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.

  6 months

Secondary Outcomes (1)

• Level of patient's awareness regarding the aesthetic appearance of the umbilicus

  Pre-operative

Study Arms (2)

Subumbilical incision

OTHER

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.

Procedure: Subumbilical incision

Transumbilical incision

OTHER

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.

Procedure: Transumbilical incision

Interventions

Transumbilical incision PROCEDURE

While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed.

Transumbilical incision

Subumbilical incision PROCEDURE

Considered here as the ''control'' intervention.

Subumbilical incision

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Patient Satisfaction; Surgical Wound

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Wounds and Injuries

Study Officials

• Nathalie McFadden, M.D

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 20, 2017
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2017
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)