Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial

NCT04231071 | Completed

• 2 other identifiers: SUMMER2020SUMMER Trial
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 7

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.

Conditions

Umbilical Hernia

Keywords

Small umbilical hernias; mesh repair; suture repair; recurrence

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  1 year

Secondary Outcomes (2)

• Difference in Surgical postoperative complication rate

  30 days

• Difference in Pain rate after surgery assessed by VHPQ

  1 year

Study Arms (2)

Sutured group

ACTIVE COMPARATOR

Controlled group: Primary suture repair of the small umbilical hernia defect

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.

Device: Onlay Mesh group

Interventions

Onlay Mesh group DEVICE

Primary suture repair with a small only mesh on the closed defect

Onlay Mesh group; Sutured group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (7)

Enköping Lasarett

Enköping, Sweden

Location

Frölunda Hospital

Gothenburg, Sweden

Location

Mora Lasarett

Mora, Sweden

Location

Department of Surgery at Södertälje Hospital

Södertälje, 151 39, Sweden

Location

Danderyds Hospital

Stockholm, Sweden

Location

Norrtälje Hospital

Stockholm, Sweden

Location

Sophiahemmet/GHP

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40037347 DERIVED

• 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.

  PMID: 34158088 DERIVED

MeSH Terms

Conditions

Hernia, Umbilical; Recurrence

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Resident in General Surgery

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: February 3, 2020
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: February 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)