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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patient Satisfaction, Surgical Wound, Incision, General Surgery

Intervention / Treatment
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* Procedure: Transumbilical incision
* Procedure: Subumbilical incision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subumbilical incision<br>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. | Procedure: Subumbilical incision<br>* Considered here as the ''control'' intervention.<br>|
| Other: Transumbilical incision<br>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. | Procedure: Transumbilical incision<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |