An interventional study of Transumbilical incision and Subumbilical incision in Patient Satisfaction, Surgical Wound and Incision, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Other
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.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 54 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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
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
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.
Considered here as the ''control'' intervention.
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.
Time frame: 6 months
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).
Time frame: Pre-operative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke