Ventral HerniaOPD-repairNCT07514273
Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study
A study testing Repair of small ventral hernia under lokal anesthesia, Hernia Repair and OPD Repair in people with Ventral Hernia, run by Region Örebro County at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Repair of small ventral hernia under lokal anesthesia, Hernia Repair and OPD Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hernia defect size ≤ 2 cm Primary hernia BMI ≤ 30 Age 18-80 years
Who cannot join
- Hernia defect size > 2 cm BMI > 30 Recurrent hernia Pregnancy
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Repair of small ventral hernia under lokal anesthesia, Hernia Repair, OPD Repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of small ventral hernia under lokal anesthesiaProcedure or surgery
Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study
Hernia RepairProcedure or surgery
Suture Repair of small size ventrla hernia with 2.0 Prolene suture
OPD RepairProcedure or surgery
Hernia repair is performed in outpatient department (OPD) with local anaesthetics only, without ordinary operation theatre resources.
| Study group | Role | What they receive |
|---|---|---|
| Pliot study, singel arm | Experimental | singel arm Receives: Procedure: Repair of small ventral hernia under lokal anesthesia; Procedure: Hernia Repair; Procedure: OPD Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of repair under local anesthetics only
Zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514273
- Sponsor's protocol ID
- Dnr 2023-06978-01
- Acronym
- OPD-repair
- Status last verified
- Jul 2025
- First submitted
- 5 Feb 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study
- ClinicalTrials.gov ID
- NCT07514273
- Acronym / sponsor ID
- OPD-repair / Dnr 2023-06978-01
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Pliot study, singel arm | Experimental | Procedure: Repair of small ventral hernia under lokal anesthesia, Procedure: Hernia Repair, Procedure: OPD Repairsingel arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hernia defect size ≤ 2 cm Primary hernia BMI ≤ 30 Age 18-80 years
Key exclusion criteria (1 listed)
- Hernia defect size > 2 cm BMI > 30 Recurrent hernia Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of small ventral hernia under lokal anesthesiaOutpatient Repair of Small Reducible Ventral Hernias Using Local Anesthesia: A Pilot Study | Procedure or surgery | Pliot study, singel arm |
| Hernia RepairSuture Repair of small size ventrla hernia with 2.0 Prolene suture | Procedure or surgery | Pliot study, singel arm |
| OPD RepairHernia repair is performed in outpatient department (OPD) with local anaesthetics only, without ordinary operation theatre resources. | Procedure or surgery | Pliot study, singel arm |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of small ventral hernia under lokal anesthesia, Hernia Repair and OPD Repair in people with Ventral Hernia, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility of repair under local anesthetics only (time frame: From enrollment to the end of treatment up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.