SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults—a study protocol for a prospective randomized double-blind multicenter clinical trial

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.

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P003 SUMMER TRIAL: MESH VERSUS SUTURE REPAIR IN SMALL UMBILICAL HERNIAS IN ADULTS: A STUDY PROTOCOL FOR A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL

British Journal of Surgery ◽

10.1093/bjs/znab395.002 ◽

2021 ◽

Vol 108 (Supplement_8) ◽

Author(s):

Maria Melkemichel ◽

Sven Bringman ◽

Gabriel Granåsen ◽

Björn Widhe

Keyword(s):

Clinical Trial ◽

Umbilical Hernia ◽

Standard Procedure ◽

Suture Repair ◽

Large Sample Size ◽

Recurrence Rates ◽

Double Blind ◽

Umbilical Hernia Repair ◽

Onlay Mesh

Abstract Aim A gold standard procedure for small umbilical hernia repairs is still lacking today. There is an increasing evidence that mesh could be advantageous in lowering recurrence rates. A question remains with regard to optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay-mesh can reduce recurrence rates without increasing complications compared to a simple-suture repair. Material and Methods A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4x4 cm onlay mesh to a conventional suture repair will be conducted. 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place. 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. Results 140 participants are included since February 2020 and 95 participants are randomized. Conclusions How to best repair a small umbilical hernia continues to be debated. A small onlay-mesh may become an easy and a safe method of choice to reduce recurrence rates in small umbilical hernia defects. This trial design should allow for a good assessment of differences in recurrence rate with due to the large sample size and the adequate follow-up. 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.

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Long-term follow-up after elective adult umbilical hernia repair: low recurrence rates also after non-mesh repairs

Hernia ◽

10.1007/s10029-012-0988-0 ◽

2012 ◽

Vol 17 (4) ◽

pp. 493-497 ◽

Cited By ~ 25

Author(s):

J. Dalenbäck ◽

C. Andersson ◽

D. Ribokas ◽

G. Rimbäck

Keyword(s):

Hernia Repair ◽

Umbilical Hernia ◽

Recurrence Rates ◽

Umbilical Hernia Repair ◽

Long Term Follow Up

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Outcomes of Laparoscopic-Assisted, Open Umbilical Hernia Repair

The American Surgeon ◽

10.1177/0003134820942162 ◽

2020 ◽

Vol 86 (8) ◽

pp. 1001-1004

Author(s):

Jenny M. Shao ◽

Sharbel A. Elhage ◽

Tanu Prasad ◽

Paul D. Colavita ◽

Vedra A. Augenstein ◽

...

Keyword(s):

Hernia Repair ◽

Umbilical Hernia ◽

Patient Characteristics ◽

Radiographic Examination ◽

Intraperitoneal Onlay Mesh ◽

Institutional Review ◽

Umbilical Hernia Repair ◽

Onlay Mesh ◽

Laparoscopic Assisted

Umbilical hernia repair (UHR) is one of the most commonly performed hernia operations with reported recurrence rate from 1% to 54%. Our aim was to describe an open, laparoscopic-assisted (OLA) technique and its outcome in an institutional review board-approved prospective study at a tertiary hernia center from 2008 to 2019. All patients underwent a standard periumbilical incision, open dissection of the hernia, and closure of the fascial defect with laparoscopic intraperitoneal onlay mesh (IPOM) fixation with permanent tacks. A total of 186 patients were identified who underwent an OLA UHR repair. Patient characteristics are as follows: average age 52.8 ± 12.5 years, male gender 79.6%, body mass index 31.4 ± 8.0 kg/m2, and average hernia defect size of 2.8 ± 4.8 cm2. Forty-one (22.0%) patients had previous failed repair. Sixty-nine (37.1%) patients had another procedure performed at the time of the UHR, most commonly a laparoscopic transabdominal inguinal hernia repair (58%). The mean operative time was 87.3 ± 51.2 minutes, but only 63.9 ± 31.9 minutes for patients undergoing an OLA repair. There were no recurrences (0%) on abdominal physical or radiographic examination with an average follow-up of 16.5 ± 17.7 months. Postoperative complications included wound erythema (2.7%), hematomas (1.1%), seromas (2.7%), and 4.3% received postoperative oral antibiotics. One person was readmitted for seroma drainage, and another required reoperation for small bowel obstruction unrelated to the hernia repair. One patient had chronic pain requiring tack removal. With moderate follow-up, an OLA UHR with mesh appears to be a durable repair with favorable results, including those patients with recurrent hernias.

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Trocar umbilical hernia repair by open suture repair and open suture–mesh repair in an ambulatory setting in comparison to recurrent and primary umbilical hernia repair

Journal of Surgical Case Reports ◽

10.1093/jscr/rjaa270 ◽

2020 ◽

Vol 2020 (9) ◽

Author(s):

René G Holzheimer ◽

Nikolai Gaschütz

Keyword(s):

Hernia Repair ◽

Mesh Repair ◽

Umbilical Hernia ◽

Late Onset ◽

Recurrent Hernia ◽

Ambulatory Setting ◽

Suture Repair ◽

Umbilical Hernia Repair ◽

Trocar Hernia

Abstract Reports on the ambulatory open repair of umbilical trocal hernias are missing. Patients with trocar, primary and recurrent umbilical hernia open suture and open suture–mesh repair with prospective follow-up were retrospectively evaluated. Patients received perioperative antibiotic prophylaxis, preemptive analgesia and modified anesthesia. In total, 171 patients with umbilical hernia (51 years, female 14%; male 86%) were treated with open suture (n = 29; 17%) and suture–mesh (n = 142; 83%) repair. In total, 10% of patients were treated for trocar hernia (late onset), 5% for recurrent hernia and 85% for a primary umbilical hernia. In total, 29% of trocar hernia repairs had minor complications associated with obesity (40%) and comorbidity (80%). Age, suture and suture–mesh repair were not associated with complications. According to guidelines for umbilical hernia repair open flat mesh may be useful in the treatment of trocar hernia.

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O12 OPEN PREPERITONEAL INGUINAL HERNIA REPAIR, TREPP VERSUS TIPP IN A RANDOMIZED CLINICAL TRIAL

British Journal of Surgery ◽

10.1093/bjs/znab396.011 ◽

2021 ◽

Vol 108 (Supplement_8) ◽

Author(s):

Willem Bökkerink ◽

Giel Koning ◽

Patrick Vriens ◽

Roland Mollen ◽

Willem Akkersdijk ◽

...

Keyword(s):

Clinical Trial ◽

Inguinal Hernia ◽

Hernia Repair ◽

Learning Curve ◽

Randomized Clinical Trial ◽

Inguinal Hernia Repair ◽

Recurrence Rates ◽

Significant Difference ◽

Related Quality

Abstract Aim The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding Chronic Postoperative Inguinal Pain (CPIP) with low recurrence rates. Two open preperitoneal techniques, the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal (TIPP) technique, were compared in a randomized clinical trial with the hypothesis of less patients with CPIP after TREPP due to complete avoidance of nerve contact. Materials and Methods Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Prior to the trial’s start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events and Health related Quality of Life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months and 1 year. Results Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but the CPIP at rest at 1 year was comparable 1.9% after TREPP vs 1.4% after TIPP, p = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, p = 0.591). Conclusions both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1 year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.

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Umbilical Hernia Repair: Analysis after 934 Procedures

The American Surgeon ◽

10.1177/000313481508100925 ◽

2015 ◽

Vol 81 (9) ◽

pp. 899-903 ◽

Cited By ~ 5

Author(s):

Jose L. Porrero ◽

Oscar Cano-Valderrama ◽

Alberto Marcos ◽

Oscar Bonachia ◽

Beatriz Ramos ◽

...

Keyword(s):

Umbilical Hernia ◽

Reoperation Rate ◽

Suture Repair ◽

Surgery Complications ◽

Medium Term ◽

Mesh Reinforcement ◽

Umbilical Hernia Repair ◽

One Year ◽

Reoperation Rates

There is a lack of consensus about the surgical management of umbilical hernias. The aim of this study is to analyze the medium-term results of 934 umbilical hernia repairs. In this study, 934 patients with an umbilical hernia underwent surgery between 2004 and 2010, 599 (64.1%) of which were evaluated at least one year after the surgery. Complications, recurrence, and the reoperation rate were analyzed. Complications were observed in 5.7 per cent of the patients. With a mean follow-up time of 35.5 months, recurrence and reoperation rates were 3.8 per cent and 4.7 per cent, respectively. A higher percentage of female patients (60.9 % vs 29 %, P = 0.001) and a longer follow-up time (47.4 vs 35 months, P = 0.037) were observed in patients who developed a recurrence. No significant differences were observed between complications and the reoperation rate in patients who underwent Ventralex® preperitoneal mesh reinforcement and suture repair; however, a trend toward a higher recurrence rate was observed in patients with suture repair (6.5 % vs 3.2 %, P = 0.082). Suture repair had lower recurrence and reoperation rates in patients with umbilical hernias less than 1 cm. Suture repair is an appropriate procedure for small umbilical hernias; however, for larger umbilical hernias, mesh reinforcement should be considered.

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