M Melkemichel1,2, S Bringman3,4, G Granåsen5, B Widhe3,6. 1. Department of Surgery, Södertälje Hospital, Södertälje, Sweden. maria.melkemichel@ki.se. 2. Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet, Stockholm, Sweden. maria.melkemichel@ki.se. 3. Department of Surgery, Södertälje Hospital, Södertälje, Sweden. 4. Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden. 5. Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden. 6. Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet, Stockholm, Sweden.
Abstract
BACKGROUND: Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh could be advantageous compared to suture repair in lowering recurrence rates. An additional important question remains with regard to the optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduce recurrence rates without increasing the complications compared to a simple suture repair. METHODS: A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4 × 4 cm onlay mesh to a conventional suture repair will be conducted. A total of 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place using a centralized web-based system resulting in total allocation concealment. Stratification will be done by surgical site and by defect size. Trial participants and follow-up clinical surgeons will be blinded to the assigned allocation. The primary outcome assessed will be postoperative recurrence at 1 and 3 years. Secondary outcomes assessed will be postoperative complications at 30 days and pain 1 year after surgery. DISCUSSION: Currently, there has been no randomized clinical trial comparing the recurrence rates between an onlay mesh repair and a simple suture repair for small umbilical hernia defects. How to best repair a small umbilical hernia continues to be debated. This trial design should allow for a good assessment of the differences in recurrence rate due to the large sample size and the adequate follow-up. Surgeons' concerns surrounding optimal anatomical positioning and fear for larger required dissections are understandable. A small onlay mesh may become an easy and safe method of choice to reduce recurrence rates. Guidelines for small umbilical hernia repairs have stressed the need for reliable data to improve treatment recommendations. We can expect that this trial will have a direct implication on small umbilical hernia repair standards. TRIAL REGISTRATION: ClinicalTrials.gov NCT04231071. Registered on 31 January 2020. SUMMER Trial underwent external peer review as part of the funding process.
RCT Entities:
BACKGROUND: Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh could be advantageous compared to suture repair in lowering recurrence rates. An additional important question remains with regard to the optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduce recurrence rates without increasing the complications compared to a simple suture repair. METHODS: A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4 × 4 cm onlay mesh to a conventional suture repair will be conducted. A total of 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place using a centralized web-based system resulting in total allocation concealment. Stratification will be done by surgical site and by defect size. Trial participants and follow-up clinical surgeons will be blinded to the assigned allocation. The primary outcome assessed will be postoperative recurrence at 1 and 3 years. Secondary outcomes assessed will be postoperative complications at 30 days and pain 1 year after surgery. DISCUSSION: Currently, there has been no randomized clinical trial comparing the recurrence rates between an onlay mesh repair and a simple suture repair for small umbilical hernia defects. How to best repair a small umbilical hernia continues to be debated. This trial design should allow for a good assessment of the differences in recurrence rate due to the large sample size and the adequate follow-up. Surgeons' concerns surrounding optimal anatomical positioning and fear for larger required dissections are understandable. A small onlay mesh may become an easy and safe method of choice to reduce recurrence rates. Guidelines for small umbilical hernia repairs have stressed the need for reliable data to improve treatment recommendations. We can expect that this trial will have a direct implication on small umbilical hernia repair standards. TRIAL REGISTRATION: ClinicalTrials.gov NCT04231071. Registered on 31 January 2020. SUMMER Trial underwent external peer review as part of the funding process.