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

Université de Sherbrooke54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Patient Satisfaction Surgical Wound Incision General Surgery

Interventions

Transumbilical incisionPROCEDURE

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.

Subumbilical incisionPROCEDURE

Considered here as the ''control'' intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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).

Time frame: Pre-operative

Data from ClinicalTrials.gov

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