Outpatient Department Repair of Small Primary Ventral Hernias

NCT07351760 | Completed

• 1 other identifier: OPD-R
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Local anesthesia; Hernia Repair; Daycare surgery; Umbilical hernia

Outcome Measures

Primary Outcomes (1)

• Complications

  Complications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain

  30 days

Secondary Outcomes (2)

• Pain

  Within two hours after surgery

• Hernia recurrence

  Six months

Study Arms (1)

Outpatient department repair

EXPERIMENTAL

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

Procedure: Outpatient department repair

Interventions

Outpatient department repair PROCEDURE

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

Outpatient department repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karlskoga Hospital

Karlskoga, Sweden

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 20, 2026
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: January 2026 - December 2030
• Access Criteria: Data are available on request to the responsible researchers.

Locations

SE (1)