Umbilical Hernia RepairOPD-RNCT07351760
Outpatient Department Repair of Small Primary Ventral Hernias
A study testing Outpatient department repair in people with Umbilical Hernia Repair and Epigastric Hernia Repair, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Umbilical Hernia Repair, Epigastric Hernia Repair, Primary Ventral and Incisional Hernia Repair
- What is being tested?
- Outpatient department repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 31 Dec 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
- Age 18-80 years
- Body mass index (BMI) ≤ 30 kg/m²
- Primary ventral hernia with fascia defect size < 2 cm
Who cannot join
- Inability or unwillingness to provide informed consent
- Contraindications to local anaesthesia
- Pregnancy
- BMI > 30 kg/m²
- Ongoing anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Umbilical Hernia Repair, Epigastric Hernia Repair, Primary Ventral and Incisional Hernia Repair
- Being tested
- Outpatient department repair
- Keywords
- Local anesthesia, Hernia Repair, Daycare surgery, Umbilical hernia
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient department repairProcedure or surgery
Outpatient department repair of selected small primary ventral hernias under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Outpatient department repair | Experimental | Outpatient department repair of selected small primary ventral hernias under local anesthesia Receives: Procedure: Outpatient department repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Complications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain
Measured: 30 days
Secondary outcomes (2)
Pain
Intraoperative pain measured with visual analogue scale (VAS)
Measured: Within two hours after surgery
Hernia recurrence
Hernia recurrence detected at follow-up
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Hernia RepairStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351760
- Sponsor's protocol ID
- OPD-R
- Acronym
- OPD-R
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Psuedonymized data are available on request from Gabriel Sandblom or Asmatullah Katawazai
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Department Repair of Small Primary Ventral Hernias
- ClinicalTrials.gov ID
- NCT07351760
- Acronym / sponsor ID
- OPD-R / OPD-R
- Conditions
- Umbilical Hernia Repair, Epigastric Hernia Repair, Primary Ventral and Incisional Hernia Repair
- Keywords
- Local anesthesia, Hernia Repair, Daycare surgery, Umbilical hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient department repair | Experimental | Procedure: Outpatient department repairOutpatient department repair of selected small primary ventral hernias under local anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Body mass index (BMI) ≤ 30 kg/m²
- Primary ventral hernia with fascia defect size < 2 cm
Key exclusion criteria (5 listed)
- Inability or unwillingness to provide informed consent
- Contraindications to local anaesthesia
- Pregnancy
- BMI > 30 kg/m²
- Ongoing anticoagulant therapy
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 |
|---|---|---|
| Outpatient department repairOutpatient department repair of selected small primary ventral hernias under local anesthesia | Procedure or surgery | Outpatient department repair |
Primary outcome
Complications
Time frame: 30 days
Complications related to the procedure, including surgical site infections, hematoma and severe intraoperative pain
2 secondary outcomes
Pain
Time frame: Within two hours after surgery
Hernia recurrence
Time frame: Six months
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 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Psuedonymized data are available on request from Gabriel Sandblom or Asmatullah Katawazai
Related trials for Umbilical Hernia Repair
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical Hernia
Umbilical Hernia Repair
Recruiting
Robotic Single Port Combined Umbilical and Inguinal Hernia Repair
Inguinal Hernia Repair, Umbilical Hernia Repair
Enrolling by invitationObservational study
Patient Reported Outcome Measures in Umbilical Hernia Surgery
Umbilical Hernia Repair
Active, not recruiting
Comparison of Onlay Mesh Repair and Sublay Mesh Repair in Umbilical Hernia Surgery
Umbilical Hernia Repair, Onlay Mesh
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 Outpatient department repair in people with Umbilical Hernia Repair and Epigastric Hernia Repair, run by Karolinska Institutet 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 3 inclusion and 5 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 26 Jan 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?
Complications (time frame: 30 days). 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 26 Jan 2026.