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Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial (SUMMER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231071
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Melkemichel, Karolinska Institutet

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Device: Onlay Mesh group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Controlled Multicenter Trial Comparing Suture and Mesh Repair in Small Umbilical Hernias in Adults
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Sutured group
Controlled group: Primary suture repair of the small umbilical hernia defect
Device: Onlay Mesh group
Primary suture repair with a small only mesh on the closed defect

Experimental: Onlay Mesh group
Intervention group: Primary suture repair of the small umbilical hernia defects + a small Onlay mesh on the closed defect.
Device: Onlay Mesh group
Primary suture repair with a small only mesh on the closed defect




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Difference in Surgical postoperative complication rate [ Time Frame: 30 days ]
    To compare the two groups of patients with regard to surgical postoperative complications (seroma, hematoma, infection) 30 days after surgery.

  2. Difference in Pain rate after surgery assessed by VHPQ [ Time Frame: 1 year ]
    To compare the two groups of patients with regard to postoperative pain rate 1 year after surgery assessed by VHPQ (Ventral Hernia Pain Questionnaire)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

• Elective surgery of a primary umbilical hernia with a defect ≤ 2 cm that is measured clinically or with radiology.

Exclusion Criteria:

  • 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
  • Pregnancy
  • Infected wounds
  • Acute operation (incarcerated hernia)
  • BMI>35
  • Ascites
  • Immunosuppression
  • Anticoagulant treatment (Warfarin, NOAK)
  • Connective tissue disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231071


Contacts
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Contact: Maria Melkemichel, MD +46701597660 maria.melkemichel@ki.se
Contact: Björn Widhe, MD, PhD +46735259624 bjorn.widhe@ki.se

Locations
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Sweden
Enköping Lasarett Recruiting
Enköping, Sweden
Contact: Björn Widhe, MD, PhD         
Frölunda Hospital Recruiting
Gothenburg, Sweden
Contact: Simone Schult, MD         
Mora Lasarett Recruiting
Mora, Sweden
Contact: Johanna Österberg, MD, PhD         
Danderyds Hospital Recruiting
Stockholm, Sweden
Contact: Anna Löf Granström, MD, PhD         
Norrtälje Hospital Recruiting
Stockholm, Sweden
Contact: Krister Sjödahl, MD, PhD         
St Görans Hospital Recruiting
Stockholm, Sweden
Contact: Hans Edvardsson, MD         
Department of Surgery at Södertälje Hospital Recruiting
Södertälje, Sweden, 151 39
Contact: Maria Melkemichel, MD    +46701597660    maria.melkemichel@ki.se   
Principal Investigator: Maria Melkemichel, MD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Björn Widhe, MD, PhD Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
Principal Investigator: Sven Bringman, MD, PhD Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Maria Melkemichel, Karolinska Institutet:
Study Protocol  [PDF] October 10, 2019
Statistical Analysis Plan  [PDF] October 10, 2019

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Responsible Party: Maria Melkemichel, Medical Doctor, Resident in General Surgery, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04231071    
Other Study ID Numbers: SUMMER2020
SUMMER Trial ( Other Identifier: Karolinska Institute )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Melkemichel, Karolinska Institutet:
Small umbilical hernias
mesh repair
suture repair
recurrence
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal