Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial (SUMMER)
Primary Purpose
Umbilical Hernia
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Onlay Mesh group
Sponsored by
About this trial
This is an interventional treatment trial for Umbilical Hernia focused on measuring Small umbilical hernias, mesh repair, suture repair, recurrence
Eligibility 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
Sites / Locations
- Enköping LasarettRecruiting
- Frölunda HospitalRecruiting
- Mora LasarettRecruiting
- Danderyds HospitalRecruiting
- Norrtälje HospitalRecruiting
- Sophiahemmet/GHPRecruiting
- Department of Surgery at Södertälje HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sutured group
Onlay Mesh group
Arm Description
Controlled group: Primary suture repair of the small umbilical hernia defect
Intervention group: Primary suture repair of the small umbilical hernia defects + a small Onlay mesh on the closed defect.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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)
Full Information
NCT ID
NCT04231071
First Posted
January 10, 2020
Last Updated
October 7, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04231071
Brief Title
Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial
Acronym
SUMMER
Official Title
Randomized Double-blind Controlled Multicenter Trial Comparing Suture and Mesh Repair in Small Umbilical Hernias in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
Keywords
Small umbilical hernias, mesh repair, suture repair, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sutured group
Arm Type
Active Comparator
Arm Description
Controlled group: Primary suture repair of the small umbilical hernia defect
Arm Title
Onlay Mesh group
Arm Type
Experimental
Arm Description
Intervention group: Primary suture repair of the small umbilical hernia defects + a small Onlay mesh on the closed defect.
Intervention Type
Device
Intervention Name(s)
Onlay Mesh group
Intervention Description
Primary suture repair with a small only mesh on the closed defect
Primary Outcome Measure Information:
Title
Hernia recurrence rate
Description
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
Time Frame
3 year
Title
Hernia recurrence rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Difference in Surgical postoperative complication rate
Description
To compare the two groups of patients with regard to surgical postoperative complications (seroma, hematoma, infection) 30 days after surgery.
Time Frame
30 days
Title
Difference in Pain rate after surgery assessed by VHPQ
Description
To compare the two groups of patients with regard to postoperative pain rate 1 year after surgery assessed by VHPQ (Ventral Hernia Pain Questionnaire)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Melkemichel, MD
Phone
+46701597660
Email
maria.melkemichel@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Widhe, MD, PhD
Phone
+46735259624
Email
bjorn.widhe@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Widhe, MD, PhD
Organizational Affiliation
Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven Bringman, MD, PhD
Organizational Affiliation
Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enköping Lasarett
City
Enköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Widhe, MD, PhD
Facility Name
Frölunda Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Schult, MD
Facility Name
Mora Lasarett
City
Mora
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Österberg, MD, PhD
Facility Name
Danderyds Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Löf Granström, MD, PhD
Facility Name
Norrtälje Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krister Sjödahl, MD, PhD
Facility Name
Sophiahemmet/GHP
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Loogna, MD
Facility Name
Department of Surgery at Södertälje Hospital
City
Södertälje
ZIP/Postal Code
151 39
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Melkemichel, MD
Phone
+46701597660
Email
maria.melkemichel@ki.se
First Name & Middle Initial & Last Name & Degree
Maria Melkemichel, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34158088
Citation
Melkemichel 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.
Results Reference
derived
Learn more about this trial
Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial
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