A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]

Abstract Background Incisional hernias are among the most frequent complications following abdominal surgery and cause substantial morbidity, impaired health-related quality of life and costs. Despite improvements in abdominal wall closure techniques, the risk for developing an incisional hernia is reported to be between 10 and 30% following midline laparotomies. There have been two recent innovations with promising results to reduce hernia risks, namely the small stitches technique and the placement of a prophylactic mesh. So far, these two techniques have not been evaluated in combination. Methods The HULC trial is a multicentre, randomized controlled, observer- and patient-blinded surgical effectiveness trial with two parallel study groups. A total of 812 patients scheduled for elective abdominal surgery via a midline laparotomy will be randomized in 12 centres after informed consent. Patients will be randomly assigned to the control group receiving closure of the midline incision with a slowly absorbable monofilament suture in the small stitches technique or to the intervention group, who will receive a small stitches closure followed by augmentation with a light-weight polypropylene mesh in the onlay technique. The primary endpoint will be the occurrence of incisional hernias, as defined by the European Hernia Society, within 24 months after surgery. Further perioperative parameters, as well as patient-reported outcomes, will be analysed as secondary outcomes. Discussion The HULC trial will address the yet unanswered question of whether a combination of small stitched fascial closure and onlay mesh augmentation after elective midline laparotomies reduces the risk of incisional hernias. The HULC trial marks the logical and innovative next step in the development of a safe abdominal closure technique. Trial registration German Clinical Trials Register, DRKS00017517. Registered on 24th June 2019.

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Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial, DRKS00017517): Study protocol for a randomized controlled trial

10.21203/rs.2.13713/v1 ◽

2019 ◽

Author(s):

Patrick Heger ◽

Manuel Feißt ◽

Johannes Krisam ◽

Christina Klose ◽

Colette Dörr-Harim ◽

...

Keyword(s):

Abdominal Surgery ◽

Abdominal Wall ◽

Fascial Closure ◽

Abdominal Wall Closure ◽

Midline Laparotomy ◽

Incisional Hernias ◽

Randomized Controlled ◽

Onlay Technique ◽

Mesh Augmentation ◽

Patient Reported

Abstract Background Incisional hernias are among the most frequent complications following abdominal surgery and cause substantial morbidity, impaired health-related quality of life and costs. Despite improvements in abdominal wall closure techniques incisional hernia rates are reported to be between 10-30% following midline laparotomies. There have been two recent innovations with promising results to reduce hernia rates, namely the small stitches technique and the placement of a prophylactic mesh. So far, these two techniques have not been evaluated in combination.Methods The HULC trial is a multicentre randomized controlled, observer and patient blinded surgical effectiveness trial with two parallel study groups. A total of 812 patients scheduled for elective abdominal surgery via a midline laparotomy will be randomized in 12 centres after informed consent. Patients will be randomly assigned to the control group receiving closure of the midline incision with a slowly absorbable monofilament suture in small stitches technique or to the intervention group that will receive a small stitches closure followed by augmentation with a light-weight polypropylen mesh in onlay technique. The primary endpoint will be the occurrence of incisional hernias as defined by the European Hernia Society within 24 months after surgery. Further perioperative parameters, as well as patient-reported outcomes, will be analysed as secondary outcomes.Discussion The HULC trial will address the yet unanswered question whether a combination of small stitched fascial closure and onlay mesh augmentation after elective midline laparotomies reduces the rate of incisional hernias. The HULC trial marks the logical and innovative next step in the development of a safe abdominal closure technique.

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Evaluation of a new technique for abdominal wall closure in midline laparotomies

International Surgery Journal ◽

10.18203/2349-2902.isj20183188 ◽

2018 ◽

Vol 5 (8) ◽

pp. 2701

Author(s):

Moharam Abdelsamie Mohamed Abd El Shahid ◽

Fawzy Abo Bakre Mahmoud ◽

Said Ebrahim Elmallah

Keyword(s):

Abdominal Wall ◽

Wound Dehiscence ◽

New Technique ◽

Abdominal Wall Closure ◽

University Hospitals ◽

Midline Laparotomy ◽

Randomized Clinical Study ◽

A New Technique ◽

One Year ◽

Critical Aspects

Background: An efficient technique for abdominal wall closure should provide strength and be a barrier against infection. Method of closure and type of suture material are critical aspects of an effective abdominal wall closure after midline laparotomy. Dehiscence of abdominal wounds after closure is a serious complication especially in emergency laparotomies. Our study was done to know whether our method of abdominal closure was helpful in reducing incidence of wound dehiscence.Methods: Present study was carried out as a retrospective randomized clinical study in the department of general surgery, Menoufia University Hospitals for one year starting from March 2017 to March 2018. 168 patients had midline laparotomies (either elective or emergent) for inflammatory, traumatic or neoplastic indications.Results: In present study for this new technique of abdominal wall closure after midline laparotomies, wound infection was noticed in 12/168 (7.2%) cases and 2/168 (1.2%) patients developed wound dehiscence.Conclusions: Present study demonstrates that our new technique (Moharam Repair) of abdominal wall closure after midline laparotomies) is efficient in reducing post-operative wound dehiscence (burst abdomen). So, this technique is applicable, safe, and can minimize morbidities and mortalities related to wound dehiscence (as a short-term complication) after midline exploratory laparotomies (MEL).

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Searching for the safest abdominal closure technique after emergency laparotomy for Hinchey III and IV peritonitis

International Surgery Journal ◽

10.18203/2349-2902.isj20173388 ◽

2017 ◽

Vol 4 (8) ◽

pp. 2534

Author(s):

Nicolo Tamini ◽

Marco Cereda ◽

Giulia Capelli ◽

Alessandro Giani ◽

Luca Gianotti

Keyword(s):

Incisional Hernia ◽

Surgical Site Infection ◽

Abdominal Wall ◽

Data Retrieval ◽

Fascial Closure ◽

Skin Closure ◽

Absorbable Suture ◽

Site Infection ◽

Abdominal Wall Closure ◽

Midline Laparotomy

Background: The optimal strategy for abdominal wall closure has been an ongoing issue of debate and convincing evidence is still lacking. The INLINE systematic review and meta-analysis published on annals of surgery 2010 suggested that a running suture with a slowly absorbable suture material was the gold standard technique for abdominal wall closure after elective surgery, while there’s no general agreement in the emergency setting.Methods: Retrospective study regarding patients who underwent emergency surgery for a generalized peritonitis due to colonic perforation from 2002 to 2014 at San Gerardo hospital (Monza, Italy). Particularly study analyzed differences between continuous suture (Maxon loop, Covidien ©) and interrupted suture (Safil, B. Braun ©) for fascial closure and between metallic clips and second intention healing for incision management. After completion of data retrieval, 110 patients were included in the statistical analysis.Results: Incisional hernia rate was 15/101 (14.9%) and surgical site infection rate was 29/110 (26.4%). No significant statistical differences were found between incidence of incisional hernia and surgical site infection in the two groups, although there was a higher prevalence of incisional hernia in the running suture group (25% vs 11,7%). There was no difference between skin-stapler’s and second-intention’s wound closure groups in terms of surgical site infection and incisional hernia development.Conclusions: We consider reasonable to use an interrupted long time absorbable suture for fascial closure after emergency midline laparotomy for Hinchey III and IV peritonitis, at least in high-risk patients. Considering skin closure, suggestion is to perform a primary skin closure.

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