Back to resultsSub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial
Primary Purpose
Patient Satisfaction, Surgical Wound, Incision
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transumbilical incision
Subumbilical incision
Sponsored by
About this trial
This is an interventional other trial for Patient Satisfaction
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Subumbilical incision
Transumbilical incision
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03026400
First Posted
January 6, 2017
Last Updated
July 30, 2021
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT03026400
Brief Title
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial
Official Title
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction, Surgical Wound, Incision, General Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subumbilical incision
Arm Type
Other
Arm Description
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.
Arm Title
Transumbilical incision
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transumbilical incision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subumbilical incision
Intervention Description
Considered here as the ''control'' intervention.
Primary Outcome Measure Information:
Title
Change in postoperative patient's aesthetic satisfaction
Description
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 Outcome Measure Information:
Title
Level of patient's awareness regarding the aesthetic appearance of the umbilicus
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie McFadden, M.D
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial
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