Transverse Versus Longitudinal Groin Incision in Vascular Surgery

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease(PAD); Aneurysmal Disease
• Interventions: Procedure: Transverse groin incision; Procedure: Longitudinal incision

• Registration Number: NCT06631378
• Lead Sponsor: Kolding Sygehus

Brief Summary

The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery.

The main questions it aims to answer are:

Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate.

Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2024-11-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• Patients undergoing vascular reconstruction with a groin incision

Exclusion Criteria

• Patients previously operated with a groin incision.
• Patients undergoing operation due to trauma, bleeding, or pseudoaneurysm.
• Patients operated within the first 24 hours of admission.
• If it prior to the operation is deemed necessary with a muscleplasty.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transverse groin incision	Transverse groin incision	-
Longitudinal groin incision	Longitudinal incision	-

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site complications	35 days after the operation	The surgical site complications are defined as follows: * Surgical site infection according to the Szilagy classification: * Dehiscence with separation of the wound edges and exposure of the underlying tissue.; * Lymhocele defined as the presence of localized swelling in the groin and verified on ultrasound as an anechoic fluid collection.; * Hematoma defined as the presence of localized swelling in the groin with discoloration and verified on ultrasound as an echoic fluid collection.

Secondary Outcome Measures

Name	Time	Method
Reoperation	35 days after the operation	Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation
Readmission	35 days	Is the patient readmitted due to either surgical site complications or for other reasons
• Length of stay	35 days	The duration of the hospital stay after the operation.
Mortality	35 days	Death and the cause of death.
Healing of the groin	35 days	Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications.