Outpatient Department Repair of Small Primary Ventral Hernias (OPD-R)

Karolinska Institute

Status: Completed

Conditions: Epigastric Hernia Repair; Primary Ventral and Incisional Hernia Repair; Umbilical Hernia Repair

Treatments: Procedure: Outpatient department repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07351760

OPD-R

Details and patient eligibility

About

Ventral hernias are among the most common conditions requiring surgical intervention. Due to their benign nature, elective repairs of primary ventral hernias are usually given low priority for planned surgery. Routines for hernia repair that do not require operating theatre resources are therefore needed.

Repair under local anaesthesia has been demonstrated to be a safe and effective approach. While inguinal hernia repair under local anaesthesia is well established and extensively studied, primary ventral hernia repair under local anaesthesia has received comparatively limited attention. Although previous studies have demonstrated the safety of primary ventral hernias repair under local anaesthesia, most procedures are still performed in conventional operating theatres. The present prospective pilot study was therefore designed to assess the safety, feasibility, and patient satisfaction of repairing small, uncomplicated primary ventral hernias under local anaesthesia in the outpatient department using suture repair, without the resources available in the operating theatre.

The study is conducted as a single-arm pilot study. Adult patients of both sexes diagnosed with a small primary ventral hernia were assessed for eligibility. The primary outcome is the safety and feasibility of performing PVH repair under local anesthesia in the outpatient department, including patient tolerance and perioperative safety. Secondary outcomes included patient satisfaction, postoperative pain, and short-term recurrence.

Outpatient Department Repair is performed in a designated outpatient procedure room, separate from the conventional operating theatre. Local anesthesia is administered in a stepwise manner. Initially, local anesthesia is injected intradermally at the incision site. After confirming adequate anesthetic effect, a skin incision is made, and the subcutaneous tissue is dissected until the hernia sac is identified. Additional local anesthesia is applied directly into the wound at this stage.

For umbilical or paraumbilical hernias, the umbilicus is carefully separated from the hernia sac and surrounding fascia. During this phase, patients are asked standardized intraoperative questions while the surgeon continues the procedure. The hernia sac is reduced, and a further infiltration of local anesthesia is administered into the fascia adjacent to the defect.

The fascial defect is closed with a single horizontal running suture line using a continuous 2-0 polypropylene suture. When applicable, the umbilicus is reattached to the fascia using a 4-0 polydioxanone suture, positioned approximately 1 cm above or below the fascial suture line, to reduce the risk of suture sinus or chronic pain. The subcutaneous tissue is sutured with 3-0 polyglactin, and the skin is closed intracutaneously using 4-0 Monocryl.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years
• Body mass index (BMI) ≤ 30 kg/m²
• Primary ventral hernia with fascia defect size < 2 cm

Exclusion criteria

• Inability or unwillingness to provide informed consent
• Contraindications to local anaesthesia
• Pregnancy
• BMI > 30 kg/m²
• Ongoing anticoagulant therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Outpatient department repair

Experimental group

Description:

Outpatient department repair of selected small primary ventral hernias under local anesthesia

Treatment:

Procedure: Outpatient department repair