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

U

Université de Sherbrooke

Status

Completed

Conditions

General Surgery
Surgical Wound
Patient Satisfaction
Incision

Treatments

Procedure: Transumbilical incision
Procedure: Subumbilical incision

Study type

Interventional

Funder types

Other

Identifiers

NCT03026400
2014-688

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Subumbilical incision
Other group
Description:
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.
Treatment:
Procedure: Subumbilical incision
Transumbilical incision
Other group
Description:
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.
Treatment:
Procedure: Transumbilical incision

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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