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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03026400
Other study ID # 2014-688
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date July 2017

Study information

Verified date July 2021
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 2017
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Intervention

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.
Subumbilical incision
Considered here as the ''control'' intervention.

Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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