Umbilical HerniaSUMMERNCT04231071
Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial
A study testing Onlay Mesh group in people with Umbilical Hernia, run by Karolinska Institutet at 7 sites in Sweden.
Trial summary
Umbilical hernia repair is one of the most common surgical performance in general surgery. Up to now, the use of suture repair has been the preferred technique for small umbilical hernia defects without any gold standard procedure. Mesh have been reserved to larger umbilical hernia defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Onlay Mesh group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesSweden
- Study dates
- 3 Feb 2020to 3 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery of a primary umbilical hernia with a defect ≤ 2 cm that is measured clinically or with radiology.
Who cannot join
- Incisional hernia: previous surgery in the area of the operation
- Recurrent umbilical hernia
- Epigastric hernia (a defect from 3 cm below the xiphoid till 3 cm above the umbilicus) [20]
- Another operative procedure at the same time (i.e. cholecystectomy)
- An umbilical hernia with a defect > 2 cm measured clinically, with radiology or intra-operatively
- Multiple defects
Show all 14Show fewer
- Pregnancy
- Infected wounds
- Acute operation (incarcerated hernia)
- BMI>35
- Ascites
- Immunosuppression
- Anticoagulant treatment (Warfarin, NOAK)
- Connective tissue disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Enköping Lasarett
Enköping
Frölunda Hospital
Gothenburg
Mora Lasarett
Mora
Department of Surgery at Södertälje Hospital
Södertälje, 151 39
Danderyds Hospital
Stockholm
Norrtälje Hospital
Stockholm
Sophiahemmet/GHP
Stockholm
About this study
Official title: Randomized Double-blind Controlled Multicenter Trial Comparing Suture and Mesh Repair in Small Umbilical Hernias in Adults
Umbilical hernia repair is one of the most common surgical performance in general surgery. Up to now, the use of suture repair has been the preferred technique for small umbilical hernia defects without any gold standard procedure. Mesh have been reserved to larger umbilical hernia defects. However, there is an increasing evidence that mesh reinforcement could be advantageous to lower the high recurrence rates also in smaller umbilical hernias. A remained important question is in what anatomical position the mesh should be placed. The investigators hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduces recurrence rates without increasing postoperative complications compared to a suture repair.
Read the detailed description
The trial is a prospective multicenter randomized clinical trial comparing onlay mesh to suture repair. Two hundred and eighty-eight patients with a primary elective umbilical hernia below and equal to 2 cm from seven Swedish participating surgical centers will be enrolled. Randomization will be performed intraoperatively following the measurement of the defect (with stratification for centra and for the defect size) to either closing the small umbilical defect with a simple primary suture repair or closing the defect with a simple primary suture repair with an attached small flat lightweight polypropylene only mesh on the aponeurosis. Trial participants, investigators and follow-up clinical surgeons will be blinded for the assigned allocation. The primary endpoint will be recurrence at 1 and 3 years. Secondary endpoint will be surgical site postoperative complications at 30 days and pain 1 year after surgery. As follows, participants will be visiting the outpatient clinical at 30 d, 1 year and 3 year after surgery.
All analyses will be performed according to the intention to treat principle and as specified in the analyses plan of the study protocol.
There is no randomized clinical trial today comparing recurrence rates between an onlay mesh repair and a suture repair for small umbilical hernia defects. The trial design allows a good detection of differences in recurrence with the large sample size and the adequate follow-up. Surgeons are becoming more aware of the mesh's advantage even for the small defects, but are reluctant to use a mesh due to anatomical positions with a large dissection and an increased risk of complications. A small onlay mesh could be an easy and safe method of choice for small umbilical hernia defects to avoid increased recurrence rates. Guidelines for small umbilical hernia repairs have stressed out the need for reliable data for treatment recommendations. The investigators can expect that the trial will have a direct implication on small umbilical hernia repair standards.
The clinical study protocol has underwent full external peer review as part of the funding process with Research funding from SLL (Stockholms läns landsting) Karolinska Institutet. Approval of the protocol by the Swedish Ethical Review Authority was obtained at December 2018 and January 2020.
- Conditions
- Umbilical Hernia
- Being tested
- Onlay Mesh group
- Keywords
- Small umbilical hernias, mesh repair, suture repair, recurrence
- Medical subject headings
- Hernia, Umbilical, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay Mesh groupDevice
Primary suture repair with a small only mesh on the closed defect
| Study group | Role | What they receive |
|---|---|---|
| Sutured group | Active comparator | Controlled group: Primary suture repair of the small umbilical hernia defect Receives: Device: Onlay Mesh group |
| Onlay Mesh group | Experimental | Intervention group: Primary suture repair of the small umbilical hernia defects + a small Onlay mesh on the closed defect. Receives: Device: Onlay Mesh group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence rate
To evaluate whether an onlay mesh in the repair of primary small umbilical hernias ≤ 2 cm reduces recurrence rate compared to suture repair 3 year after surgery
Measured: 3 year
Hernia recurrence rate
To evaluate whether an onlay mesh in the repair of primary small umbilical hernias ≤ 2 cm reduces recurrence rate compared to suture repair 1 year after surgery.
Measured: 1 year
Secondary outcomes (2)
Difference in Surgical postoperative complication rate
To compare the two groups of patients with regard to surgical postoperative complications (seroma, hematoma, infection) 30 days after surgery.
Measured: 30 days
Difference in Pain rate after surgery assessed by VHPQ
To compare the two groups of patients with regard to postoperative pain rate 1 year after surgery assessed by VHPQ (Ventral Hernia Pain Questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start3 Feb 2020
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Umbilical HerniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Melkemichel, Karolinska Institutet
- Investigators
- Björn Widhe, MD, PhD, Principal investigator, Department of Clinical Sciences, Danderyds Hospital, Karolinska InstitutetSven Bringman, MD, PhD, Principal investigator, Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231071
- Sponsor's protocol ID
- SUMMER2020
- Other IDs
- SUMMER Trial
- Acronym
- SUMMER
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergstrom M, Widhe B, Granasen G, Lof Granstrom A, Ohlsson J, Schult S, Dahlstrand U, Osterberg J, Loogna P, Bringman S, Melkemichel M. Onlay mesh versus suture repair for smaller umbilical hernias in adults-early results from SUMMER trial: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae173. doi: 10.1093/bjsopen/zrae173.
PubMed 40037347Melkemichel M, Bringman S, Granasen G, Widhe B. SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults-a study protocol for a prospective randomized double-blind multicenter clinical trial. Trials. 2021 Jun 22;22(1):411. doi: 10.1186/s13063-021-05366-7.
PubMed 34158088
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Multicenter Trial Comparing Suture and Mesh Repair in Small Umbilical Hernias in Adults
- ClinicalTrials.gov ID
- NCT04231071
- Acronym / sponsor ID
- SUMMER / SUMMER2020
- Conditions
- Umbilical Hernia
- Keywords
- Small umbilical hernias, mesh repair, suture repair, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 18 Jan 2020 (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.
Umbilical hernia repair is one of the most common surgical performance in general surgery. Up to now, the use of suture repair has been the preferred technique for small umbilical hernia defects without any gold standard procedure. Mesh have been reserved to larger umbilical hernia defects. However, there is an increasing evidence that mesh reinforcement could be advantageous to lower the high recurrence rates also in smaller umbilical hernias. A remained important question is in what anatomical position the mesh should be placed. The investigators hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduces recurrence rates without increasing postoperative complications compared to a suture repair.
Detailed description
The trial is a prospective multicenter randomized clinical trial comparing onlay mesh to suture repair. Two hundred and eighty-eight patients with a primary elective umbilical hernia below and equal to 2 cm from seven Swedish participating surgical centers will be enrolled. Randomization will be performed intraoperatively following the measurement of the defect (with stratification for centra and for the defect size) to either closing the small umbilical defect with a simple primary suture repair or closing the defect with a simple primary suture repair with an attached small flat lightweight polypropylene only mesh on the aponeurosis. Trial participants, investigators and follow-up clinical surgeons will be blinded for the assigned allocation. The primary endpoint will be recurrence at 1 and 3 years. Secondary endpoint will be surgical site postoperative complications at 30 days and pain 1 year after surgery. As follows, participants will be visiting the outpatient clinical at 30 d, 1 year and 3 year after surgery.
All analyses will be performed according to the intention to treat principle and as specified in the analyses plan of the study protocol.
There is no randomized clinical trial today comparing recurrence rates between an onlay mesh repair and a suture repair for small umbilical hernia defects. The trial design allows a good detection of differences in recurrence with the large sample size and the adequate follow-up. Surgeons are becoming more aware of the mesh's advantage even for the small defects, but are reluctant to use a mesh due to anatomical positions with a large dissection and an increased risk of complications. A small onlay mesh could be an easy and safe method of choice for small umbilical hernia defects to avoid increased recurrence rates. Guidelines for small umbilical hernia repairs have stressed out the need for reliable data for treatment recommendations. The investigators can expect that the trial will have a direct implication on small umbilical hernia repair standards.
The clinical study protocol has underwent full external peer review as part of the funding process with Research funding from SLL (Stockholms läns landsting) Karolinska Institutet. Approval of the protocol by the Swedish Ethical Review Authority was obtained at December 2018 and January 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutured group | Active comparator | Device: Onlay Mesh groupControlled group: Primary suture repair of the small umbilical hernia defect |
| Onlay Mesh group | Experimental | Device: Onlay Mesh groupIntervention group: Primary suture repair of the small umbilical hernia defects + a small Onlay mesh on the closed defect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgery of a primary umbilical hernia with a defect ≤ 2 cm that is measured clinically or with radiology.
Key exclusion criteria (14 listed)
- Incisional hernia: previous surgery in the area of the operation
- Recurrent umbilical hernia
- Epigastric hernia (a defect from 3 cm below the xiphoid till 3 cm above the umbilicus) [20]
- Another operative procedure at the same time (i.e. cholecystectomy)
- An umbilical hernia with a defect > 2 cm measured clinically, with radiology or intra-operatively
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 |
|---|---|---|
| Onlay Mesh groupPrimary suture repair with a small only mesh on the closed defect | Device | Onlay Mesh group, Sutured group |
Primary outcome
Hernia recurrence rate
Time frame: 3 year
To evaluate whether an onlay mesh in the repair of primary small umbilical hernias ≤ 2 cm reduces recurrence rate compared to suture repair 3 year after surgery
Hernia recurrence rate
Time frame: 1 year
To evaluate whether an onlay mesh in the repair of primary small umbilical hernias ≤ 2 cm reduces recurrence rate compared to suture repair 1 year after surgery.
2 secondary outcomes
Difference in Surgical postoperative complication rate
Time frame: 30 days
Difference in Pain rate after surgery assessed by VHPQ
Time frame: 1 year
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 6 Feb 2024.
- Derived from this study: PubMed 40037347Bergstrom M, Widhe B, Granasen G, Lof Granstrom A, Ohlsson J, Schult S, Dahlstrand U, Osterberg J, Loogna P, Bringman S, Melkemichel M. Onlay mesh versus suture repair for smaller umbilical hernias in adults-early results from SUMMER trial: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae173. doi: 10.1093/bjsopen/zrae173.
- Derived from this study: PubMed 34158088Melkemichel M, Bringman S, Granasen G, Widhe B. SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults-a study protocol for a prospective randomized double-blind multicenter clinical trial. Trials. 2021 Jun 22;22(1):411. doi: 10.1186/s13063-021-05366-7.
- 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.
Björn Widhe, MD, PhD principal investigator
Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
Sven Bringman, MD, PhD principal investigator
Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onlay Mesh group in people with Umbilical Hernia, run by Karolinska Institutet at 7 sites 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 14 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Hernia recurrence rate (time frame: 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231071, which also lists 2 linked publications.
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 6 Feb 2024.