Effect of an elastic girdle on lung function, intra-abdominal pressure, and pain after midline laparotomy: a randomized controlled trial

Background: Incisional hernia forms the most common delayed morbidity following midline laparotomy surgeries- causing mental trauma to the patient impairing their quality of life and scars the name and fame of the surgeon. So, the need for possible attributes on surgeon’s aspect to prevent the incisional hernia is the need of the hour. We planned a randomized controlled trial to compare two different abdominal closure techniques to reduce the incidence of Incisional hernia following midline laparotomy incisions. We advocated Hughes abdominal repair which includes a series of two horizontal and two vertical mattresses within single suture whereby the tension load of suture is distributed both along and across the suture line.Methods: 1:1 Randomized controlled trial in which the patient is blinded and obviously operating surgeon is non-blinded. Evaluating examiner and radiologist are blinded.100 patients who underwent emergency and elective midline laparotomies were enrolled in the study and intra-operatively randomized into two groups in 1:1 pattern. Ethical clearance obtained from the Institutional ethical committee. The primary outcome measure is the incidence of burst abdomen at the end of 15 days by the evaluating surgeon (non-operated surgeon who is blinded). The secondary outcome is the incidence of incisional hernia at the end of one year-evaluated by detailed clinical examination with radiological proof using CT abdomen.Results: The incidence of incisional hernia is significantly low in Hughes abdominal repair than conventional abdominal closure.Conclusions: Hughes abdominal wall closure is superior to conventional closure in both emergency and elective laparotomy cases, in prevention of wound dehiscence and Incisional hernias later. Present study encourages us that Hughes abdominal wall repair is comparable to mesh repairs. This study needs to be continued further to a vast sample size to perfectly assess the statistical significance.

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PREEMER trial: Study protocol for a randomized controlled trial

10.21203/rs.3.rs-18884/v1 ◽

2020 ◽

Author(s):

Elisa Mäkäräinen-Uhlbäck ◽

Matti Tolonen ◽

Ville Sallinen ◽

Panu Mentula ◽

Ari Leppäniemi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Incisional Hernia ◽

Controlled Trial ◽

Control Group ◽

Emergency Setting ◽

University Hospitals ◽

Comprehensive Complication Index ◽

Midline Laparotomy ◽

Randomized Controlled ◽

Hernia Prevention

Abstract Background: Despite the fact that, in itself, emergency midline laparotomy is a factor risk for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published.Methods: The PREEMER trial is a multicenter, double-blinded, randomized controlled trial to be conducted in seven hospitals in Finland (Oulu, Helsinki, Tampere, and Turku university hospitals and Jyväskylä, Lahti, and Seinäjoki non-university hospitals). A total of 244 patients will be randomized at a 1:1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small stitch 4:1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incisional hernia incidence two years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related re-operations within the two- and five-year follow-ups; the incidence of incisional hernia within the five-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale (AAS), and the PROMIS-questionnaire within 30 days and two and five years from surgery. Additionally, medico-economic explorative measures are analyzed.Discussion: The PREEMER Trial will provide level 1 evidence on incisional hernia prevention in an emergency setting.Trial registration: Clinical Trials NCT04311788https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009MXF&selectaction=Edit&uid=U0003YIA&ts=2&cx=7ef75k. Registered March 7th, 2020

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