General Surgery, Incision, Patient Satisfaction, Surgical Wound
Conditions
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.
Interventions
PROCEDURESubumbilical incision
Considered here as the ''control'' intervention.
PROCEDURETransumbilical 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.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative patient's aesthetic satisfaction | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of patient's awareness regarding the aesthetic appearance of the umbilicus | Pre-operative | 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). |
Countries
Canada
Outcome results
None listed