Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study (OPD-repair)

Primary midline hernias, including umbilical and epigastric hernias, are prevalent surgical conditions, necessitating intervention. The optimal choice of anesthesia for umbilical and epigastric hernia repair remains an area of uncertainty. This pilot study focuses on the management of primary midline hernias, specifically umbilical and epigastric hernias, with an emphasis on anesthesia choice and repair techniques. Debates persist regarding the timing of elective repairs for primary ventral hernias. The study is prompted by the hypothesis that local anesthesia may offer superior outcomes, particularly for frail patients. While both mesh-reinforced and suture repairs are utilized, evidence supporting the superiority of mesh for small-sized hernias is limited.

A systematic review from 2017 supports the safety and feasibility of local anesthesia for umbilical hernia repair. A retrospective study indicates favorable outcomes, reduced operating time, and increased patient satisfaction with day case procedures under local anesthesia. This study aims to assess the safety and feasibility of repairing small reducible hernias using local anesthesia in the outpatient department. The investigation seeks to provide insights into the potential advantages of local anesthesia over general anesthesia in the repair of small reducible hernias. This summary succinctly outlines the key objectives, hypotheses, and methodologies of the pilot study within the specified word limit.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Repair of small ventral hernia under lokal anesthesia; Procedure: Hernia Repair; Procedure: OPD Repair

Detailed Description

Primary midline hernias, including umbilical and epigastric hernias, are prevalent surgical conditions, necessitating intervention. Differing opinions exist among surgeons regarding the timing of elective repair for primary ventral hernias, with some advocating for immediate intervention, while others prefer a watchful waiting approach. The optimal choice of anesthesia for umbilical hernia repair remains an area of uncertainty. A systematic review published in 2017 concluded that local anesthesia for umbilical hernia repair was safe and feasible. A retrospective study, including 476 patients divided into four different types of hernias (epigastric, umbilical, small incisional, and Spigelian hernia), showed that when performed under local anesthesia as a day case procedure, it is a safe technique associated with favorable long-term outcomes. A recently published study found that the repair of ventral hernia with local anesthesia is safe, reduces operating time, and results in higher patient satisfaction.

We hypothesized that employing local anesthesia, as opposed to general anesthesia, would yield superior outcomes, particularly for frail patients. While both mesh-reinforced and suture repairs are utilized for treating primary hernias, there is limited evidence supporting the superiority of mesh repair for small-sized hernias (diameter <2 cm). A meta-analysis suggests a marginally lower recurrence rate in patients undergoing mesh repair compared to those receiving prolene-suture repair without mesh for small hernias. However, the use of mesh may introduce persistent pain or other mesh-related complications. Patients with small hernias are typically managed in the operating theater under general anesthesia, a resource-intensive and time-consuming approach associated with potential complications. Conversely, performing the procedure under local anesthesia not only enhances patient safety but also conserves resources. Previous studies have indicated that repairing ventral hernias under local anesthesia may reduce operative time and associated complications. In this pilot study, the investigators aim to assess the safety and feasibility of performing repairs for small reducible hernias using local anesthesia in the outpatient department.

Ventral hernias, particularly those located in the midline such as umbilical and epigastric hernias, represent common surgical conditions. Management strategies for these hernias vary, with debates surrounding the timing of elective repair. This pilot study aims to investigate the potential advantages of utilizing local anesthesia over general anesthesia in the repair of small reducible hernias, primarily focusing on patient safety and resource conservation.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro County
    • Karlskoga, Örebro County, Sweden, 69143
      • Hernia center Region Örebro Län

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Hernia defect size ≤ 2 cm Primary hernia BMI ≤ 30 Age 18-80 years

Exclusion Criteria:

Hernia defect size > 2 cm BMI > 30 Recurrent hernia Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pliot study, singel arm; singel arm

Procedure: Repair of small ventral hernia under lokal anesthesia; Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study; Procedure: Hernia Repair; Suture Repair of small size ventrla hernia with 2.0 Prolene suture; Procedure: OPD Repair; Hernia repair is performed in outpatient department (OPD) with local anaesthetics only, without ordinary operation theatre resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and feasibility of repair under local anesthetics only	Zero is equivalent to no pain and 10 indicates the worst possible pain	From enrollment to the end of treatment up to 12 months
Safety and feasibility of the procendure	The first five repairs will be performed in the operating theatre with anesthesiology back-up in order to evaluate feasibility and safety. The subsequent repairs will be performed in the outpatient department under local anesthesia only.	From enrollment to the end of the treatment 12 months
Number of Participants with Treatment-Related Adverse Events as Assessed by clinical follow up.	Zero is equivalent to no pain and 10 indicates the worst possible pain.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Ventral; Surgical Procedures, Operative; Plastic Surgery Procedures; Herniorrhaphy
• Other Study ID Numbers: Dnr 2023-06978-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No