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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Patient Satisfaction; General Surgery; Incision
• Intervention / Treatment: Procedure: Subumbilical incision; Procedure: Transumbilical incision

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Subumbilical incision; Considered here as the ''control'' intervention.
Other: 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.	Procedure: Transumbilical incision; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of patient's awareness regarding the aesthetic appearance of the umbilicus	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).	Pre-operative

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Nathalie McFadden, M.D, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2014-688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO