scholarly journals 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

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.

scholarly journals 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 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Melkemichel ◽  
S. Bringman ◽  
G. Granåsen ◽  
B. Widhe
Keyword(s):  
Clinical Trial ◽  
Hernia Repair ◽  
Umbilical Hernia ◽  
Suture Repair ◽  
Large Sample Size ◽  
Recurrence Rates ◽  
Double Blind ◽  
Umbilical Hernia Repair ◽  
Onlay Mesh

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.

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

Hernia ◽  
2012 ◽  
Vol 17 (4) ◽  
pp. 493-497 ◽  
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

Umbilical Hernia Repair: Analysis after 934 Procedures

2015 ◽  
Vol 81 (9) ◽  
pp. 899-903 ◽  
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.

Outcomes of Laparoscopic-Assisted, Open Umbilical Hernia Repair

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.

scholarly journals O31 SUTURE OR MESH REPAIR FOR THE SMALLEST UMBILICAL HERNIAS: A NATIONWIDE DATABASE STUDY

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Nadia Henriksen ◽  
Kristian Kiim Jensen ◽  
Thue Bisgaard ◽  
Frederik Helgstrand
Keyword(s):  
Mesh Repair ◽  
Umbilical Hernia ◽  
Cumulative Risk ◽  
Suture Repair ◽  
Early Complications ◽  
Recurrence Rates ◽  
Risk Of Recurrence ◽  
Elective Repair ◽  
Onlay Mesh ◽  
High Level

Abstract Aim High level evidence recommends the use of mesh for umbilical hernias with defects >1 cm to reduce recurrence rates without increasing the risk of postoperative complications. For umbilical hernias with defect width ≤1 cm, the literature is sparse. The aim of the study was to assess outcomes after suture and mesh repair of umbilical hernias with defect width <1 cm on a nationwide basis, and to evaluate outcomes after onlay mesh repair specifically. Material and Methods By merging data from the Danish Hernia Database and the National Patients Registry from January 2007 until December 2018, patients receiving elective repair of an umbilical hernia with defect width ≤1 cm were identified. Available data included details about comorbidity, surgical technique, 90-days readmission, 90-days reoperation and reoperation for recurrence. Results A total of 7,849 patients were included, of whom 25.7% (2,013/7,849) underwent mesh repair. The cumulative 5-year incidence of reoperation for recurrence was significantly decreased after mesh repair 3.1% (95% C.I. 2.1-4.1) compared with suture repair 6.7% (95% C.I. 6.0-7.4), P < 0.001. Onlay mesh repairs had the lowest cumulative risk of recurrence at 5 years 2.0% (95% C.I. 0.6-3.5). For onlay mesh repairs, readmission 7.9%, (65/826)) and reoperation (3.9% (32/826)) rates within 90-days were comparable to suture repairs (6.5% (381/5,836) and 3.3% (192/5,836), P = 0.149 and P = 0.382, respectively. Conclusions Even for the smallest umbilical hernias, mesh repair significantly decreased the recurrence rate. Onlay mesh repair was associated with the lowest risk of recurrence without increasing early complications.

scholarly journals Onlay mesh repair for treatment of small umbilical hernias ≤ 2 cm in adults: a single-centre investigation

Hernia ◽  
2021 ◽  
Author(s):  
M. Melkemichel ◽  
L. Stjärne ◽  
S. Bringman ◽  
B. Widhe
Keyword(s):  
Umbilical Hernia ◽  
Secondary Outcome ◽  
Suture Repair ◽  
Medical Database ◽  
Single Centre ◽  
Female Ratio ◽  
Superficial Wound ◽  
Onlay Mesh ◽  
Surgical Site Complications

Abstract Purpose Previous studies on the repair of small umbilical hernias have suggested a lower recurrence rate with mesh compared to suture repair. An important question is in what anatomical position the mesh should be placed. The purpose of this study was to investigate the outcome of using a standardized 4 × 4 cm onlay-mesh for umbilical hernias ≤ 2 cm. Methods A retrospective study was conducted at a single centre in Sweden on all umbilical hernia repairs during 2015–2019. The follow-up time was at least four months. Patients were identified using the hospital medical database. Repairs performed with suture or a sublay, ventral patch and laparoscopic mesh positioning were excluded. The patient’s demographics, comorbidities, intra—and post-operative details were considered. The primary outcome was surgical site complications within 30 days. The secondary outcome was a recurrence. Results 80 patients were repaired with a small onlay-mesh for an umbilical hernia ≤ 2 cm. The median (range) follow-up time was 29.0 (4.3–50.1) months. The median age was 46 (26–76) years old. The median body mass index was 28 (19–38) kg/m2. The male to female ratio was 2:1. 4 patients were identified with a surgical site post-operative complication; three with seromas and one with a superficial wound infection. 3 of these were given antibiotics. 2 patients were treated with wound openings bedside. There were no registered cases of recurrence. Conclusions Repairing small umbilical hernias with a small onlay-mesh was safe with a low surgical site complication rate. Randomized trials are needed to assess whether mesh can reduce recurrences in umbilical hernia repairs ≤ 2 cm.

scholarly journals 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

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.

scholarly journals P121 ONLAY MESH FOR TREATMENT OF SMALL UMBILICAL HERNIAS IN ADULTS - A SINGE CENTER INVESTIGATION

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Ludvig Stjärne ◽  
Maria Melkemichel ◽  
Sven Bringman ◽  
Björn Widhe
Keyword(s):  
Umbilical Hernia ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Suture Repair ◽  
Single Institution ◽  
Female Ratio ◽  
Superficial Wound ◽  
Onlay Mesh ◽  
Surgical Site Complications

Abstract Aim Previous studies on the repair of small umbilical hernias have suggested a lower recurrence rate with mesh compared to suture repair. A remaining important question is in what anatomical position the mesh should be placed. The purpose of this study was to investigate the outcome of using a standardized 4x4 cm onlay-mesh for umbilical hernias ≤2cm. Material and Methods A retrospective study was conducted at a single institution in Sweden on all umbilical hernia repairs during 2015-2019. The follow up time was at least four months. Patients were identified using the hospital medical record database. Repairs performed with suture, sublay, ventral patch or laparoscopic mesh positioning were excluded. Patient’s demographics, comorbidities, intra – and postoperative details were considered. Primary outcome was surgical site complications within 30 days. Secondary outcome was recurrence. Results 80 patients were repaired with a small onlay-mesh for an umbilical hernia ≤ 2 cm and were included for statistical analysis. Median (range) follow-up time was 29.0 (4.3-50.1) months. Median age was 46 (26-76) years old. Median body mass index was 28 (19-38) kg/m2. Men to female ratio was 2.1. 4 patients were identified with a surgical site postoperative complication; 3 with seroma and 1 with superficial wound infection. 3 of these were given antibiotics. 2 patients were treated with wound opening bedside. There were no registered cases of a recurrence. Conclusions Repairing small umbilical hernias with a small onlay-mesh was safe with a low surgical site complication rate. Randomized trials are needed to assess weather mesh reduce recurrences in umbilical hernia repairs ≤2cm.

scholarly journals Umbilical hernia: Factors indicative of recurrence

Medicina ◽  
2008 ◽  
Vol 44 (11) ◽  
pp. 855 ◽  
Author(s):  
Linas Venclauskas ◽  
Jolita Šilanskaitė ◽  
Mindaugas Kiudelis
Keyword(s):  
Risk Factors ◽  
Recurrence Rate ◽  
Umbilical Hernia ◽  
Hernia Recurrence ◽  
Suture Repair ◽  
Repair Technique ◽  
Umbilical Hernia Repair ◽  
Open Mesh Repair ◽  
Onlay Technique ◽  
Hernia Size

Umbilical hernia has gained little attention from surgeons in comparison with other types of abdominal wall hernias (inguinal, postoperative); however, the primary suture for umbilical hernia is associated with a recurrence rate of 19–54%. The aim of this study was to analyze the results of the umbilical hernia repair and to assess the independent risk factors influencing umbilical hernia recurrence. Materials and methods. A retrospective analysis of patients who underwent surgery for umbilical hernia in the Hospital of Kaunas University of Medicine in 2001–2006 was performed. Age, sex, hospital stay, hernia size, patient’s body mass index, and postoperative complications were analyzed. Postoperative evaluation included pain and discomfort in the abdomen and hernia recurrence rate. The questionnaire, which involved all these previously mentioned topics, was sent to all patients by mail. Hernia recurrence was diagnosed during the patients’ visit to a surgeon. Two surgical methods were used to repair umbilical hernia: open suture repair technique (keel technique) and open mesh repair technique (onlay technique). Every operation was chosen individually by a surgeon. Results. Ninety-seven patients (31 males and 66 females) with umbilical hernia were examined. The mean age of the patients was 57.1±15.4 years, hernia anamnesis – 7.6±8.6 years, hospital stay – 5.38±3.8 days. Ninety-two patients (94.8%) were operated on using open suture repair technique and 5 (5.2%) patients – open mesh repair technique. Only 7% of patients whose BMI was >30 kg/m2 and hernia size >2 cm and 4.3% of patients whose BMI was <30 kg/m2 and hernia size <2 cm were operated on using onlay technique (P>0.05). The rate of postoperative complications was 5.2%. Sixty-seven patients (69%) answered the questionnaire. The complete patient’s recovery time after surgery was 2.4±3.4 months. Fourteen patients (20.9%) complained of pain or discomfort in the abdomen, and 7 patients (10.4%) had ligature fistula after the surgery. Forty-five patients (67.2%) did not have any complaints after surgery. The recurrence rate after umbilical hernia repair was 8.9%. The recurrence rate was higher when hernia size was >2 cm (9% for <2 cm vs 10.5% for >2 cm) and patient’s BMI was >30 kg/m2 (8.6% for < 30 vs 10.7% for >30). There were 5 recurrence cases after open suture repair and one case after onlay technique. Fifty-six patients (83.6%) assessed their general condition after surgery as good, 9 patients (13.4%) as satisfactory, and only 2 patients (3%) as poor. Conclusions. We did not find any significant independent risk factors for umbilical hernia recurrence. However, based on reviewed literature, higher patient’s body mass index and hernia size of >2 cm could be the risk factors for umbilical hernia recurrence.

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