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NCT Number: NCT03026400

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

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.

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Key information

Conditions

Patient Satisfaction Behavior General Surgery Health Behavior Incision Surgical Wound Treatment Adherence and Compliance Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transumbilical incision

Procedure

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.

Subumbilical incision

Procedure

Considered here as the ''control'' intervention.

Primary outcomes

  1. Change in postoperative patient's aesthetic satisfaction

    Time frame: 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 outcomes

  1. Level of patient's awareness regarding the aesthetic appearance of the umbilicus

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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