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Completed

NCT Number: NCT07514273

Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hernia center Region Örebro Län

Karlskoga, Örebro County, 69143, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repair of small ventral hernia under lokal anesthesia

Procedure

Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study

Hernia repair

Procedure

Suture Repair of small size ventrla hernia with 2.0 Prolene suture

OPD Repair

Procedure

Hernia repair is performed in outpatient department (OPD) with local anaesthetics only, without ordinary operation theatre resources.

Primary outcomes

  1. Safety and feasibility of repair under local anesthetics only

    Time frame: From enrollment to the end of treatment up to 12 months

    Zero is equivalent to no pain and 10 indicates the worst possible pain

  2. Safety and feasibility of the procendure

    Time frame: From enrollment to the end of the treatment 12 months

    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.

  3. Number of Participants with Treatment-Related Adverse Events as Assessed by clinical follow up.

    Time frame: From enrollment to the end of treatment at 12 weeks

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Acronym: OPD-repair

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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