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CompletedNCT07351760OPD-RUpdated Jan 26, 2026

Outpatient Department Repair of Small Primary Ventral Hernias

An interventional study of Outpatient department repair in Umbilical Hernia Repair, Epigastric Hernia Repair and Primary Ventral and Incisional Hernia Repair, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Dec 2023, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Local anesthesia
  • Hernia Repair
  • Daycare surgery
  • Umbilical hernia
03

In context

Hernia, Umbilical

67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.

This study's enrollment of 37 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.

Browse Hernia, Umbilical studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability or unwillingness to provide
  • to local anaesthesia
  • Pregnancy
  • > 30 kg/m²
  • Ongoing anticoagulant therapy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Outpatient department repair

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

    Procedure: Outpatient department repair

Interventions

  • ProcedureOutpatient department repair

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

06

What researchers measure

Primary outcomes

  1. Complications

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

    Time frame: 30 days

Secondary outcomes

  1. Pain

    Intraoperative pain measured with visual analogue scale (VAS)

    Time frame: Within two hours after surgery

  2. Hernia recurrence

    Hernia recurrence detected at follow-up

    Time frame: Six months

07

Study locations

1 site
  • Karlskoga Hospital
    Karlskoga, Sweden
08

References and documents

Individual participant data

Plan to share: Yes — Psuedonymized data are available on request from Gabriel Sandblom or Asmatullah Katawazai

Supporting information: Study protocol, Statistical analysis plan

Time frame: January 2026 - December 2030

Access criteria: Data are available on request to the responsible researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07351760
Responsible party
Gabriel Sandblom (Associate Professor, Karolinska Institutet) — Principal investigator
First posted
Jan 20, 2026
Start date
Dec 1, 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jan 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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