Patient Satisfaction Clinical Trial
Official title:
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Randomised Trial
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 |
Verified date | July 2021 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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). |
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