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
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.
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 →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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Outpatient department repair of selected small primary ventral hernias under local anesthesia
Procedure: Outpatient department repair
Outpatient department repair of selected small primary ventral hernias under local anesthesia
Complications
Complications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain
Time frame: 30 days
Pain
Intraoperative pain measured with visual analogue scale (VAS)
Time frame: Within two hours after surgery
Hernia recurrence
Hernia recurrence detected at follow-up
Time frame: Six months
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.
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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