Transverse Versus Longitudinal Groin Incision in Vascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transverse groin incision, Longitudinal incision.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease(PAD), Aneurysmal Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Incidence of Surgical Site Complications in Transverse Versus Longitudinal Groin Incision in Vascular Surgery: A Randomized Clinical Trial
Overview
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.
Interventions
- Procedure Transverse groin incision
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 caps - Procedure Longitudinal incision
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.
Primary outcome measures
- Incidence of surgical site complications [Time frame: 35 days after the operation]
Secondary outcome measures (5)
- Reoperation [Time frame: 35 days after the operation]
- Readmission [Time frame: 35 days]
- • Length of stay [Time frame: 35 days]
- Mortality [Time frame: 35 days]
- Healing of the groin [Time frame: 35 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Vascular Surgery - Lillebaelt Hospital — Kolding
Identifiers
NCT: NCT06631378 · KoldingSygehusKarkir