Health TrialsbyHealthPanel

Transverse Versus Longitudinal Groin Incision in Vascular Surgery

ConditionsPeripheral Arterial Disease(PAD)Aneurysmal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKolding Sygehus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transverse groin incision

    Procedure/Surgery

    The transverse incision is made parallel to the inguinal ligament either superiorly or inferiorly to the skin crease directly over the femoral artery. The subcutaneous tissue is dissected in the transverse direction till Scarpaes fascia after which the dissection is performed in the longitudinal direction along the line of the vessels. The lymphatic vessels are spared as much as possible. Any damaged lymph vessels are closed with surgical clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage. In case of difficulty with proper access to the femoral arteries, the incision can be extended either medially, laterally, or vertically.

  • Longitudinal incision

    Procedure/Surgery

    The longitudinal incision is made directly over the femoral artery from the inguinal ligament. The subcutaneous tissue is dissected along the line of the vessel sparing the lymphatic vessels as much as possible. Any damaged lymph vessels are closed with clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage.

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Transverse groin incisionExperimental treatment 1 intervention
Group B: Longitudinal groin incisionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of surgical site complications

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.

Time frame
35 days after the operation

Secondary outcomes

1

Reoperation

Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation

Time frame
35 days after the operation
2

Readmission

Is the patient readmitted due to either surgical site complications or for other reasons

Time frame
35 days
3

• Length of stay

The duration of the hospital stay after the operation.

Time frame
35 days
4

Mortality

Death and the cause of death.

Time frame
35 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kolding Sygehus

Lead sponsor

Region of Southern Denmark

Collaborator

University of Southern Denmark

Collaborator

Source ClinicalTrials.gov
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