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Outpatient Department Repair of Small Primary Ventral Hernias

Outpatient Department Repair of Small Primary Ventral Hernias

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07351760
Acronym
OPD-R
Enrollment
37
Registered
2026-01-20
Start date
2023-12-01
Completion date
2025-12-31
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Local anesthesia, Hernia Repair, Daycare surgery, Umbilical hernia

Brief 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.

Interventions

PROCEDUREOutpatient department repair

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inability or unwillingness to provide informed consent * Contraindications to local anaesthesia * Pregnancy * BMI \> 30 kg/m² * Ongoing anticoagulant therapy

Design outcomes

Primary

MeasureTime frameDescription
Complications30 daysComplications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain

Secondary

MeasureTime frameDescription
PainWithin two hours after surgeryIntraoperative pain measured with visual analogue scale (VAS)
Hernia recurrenceSix monthsHernia recurrence detected at follow-up

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026