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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026400
• Other study ID #: 2014-688
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• General Surgery
• Incision
• Patient Satisfaction
• Surgical Wound

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