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PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Incisional hernia is a common complication after liver transplantation with an incidence of 5 to 46%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after liver transplantation with minimal risk for complication. METHODS/DESIGN:This is an unblinded, randomized controlled trial comparing time to incisional hernia over a period of 12?months between patients undergoing liver transplantation and standardized abdominal closure with or without prophylactic placement of Phasix™ (Bard - Davol Inc., Warwick, RI, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. DISCUSSION:The high risk for developing incisional hernia following liver transplantation might be reduced by prophylactic mesh placement. Immunosuppressed patients are at high risk for developing surgical-site infections. We chose a mesh which has anti-inflammatory properties and is fully resorbed after 18?months. TRIAL REGISTRATION:ClinicalTrials.gov, ID: 03222102 . Registered retrospectively on 17 July 2018. Protocol version 1.4, 7 October 2018.

SUBMITTER: Kniepeiss D

PROVIDER: S-EPMC6585129 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.

Kniepeiss Daniela D Waha James Elvis JE Auer Thomas T Berghold Andrea A Schemmer Peter P

Trials 20190620 1

<h4>Background</h4>Incisional hernia is a common complication after liver transplantation with an incidence of 5 to 46%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after liver transplantation with minimal risk for complication.<h4>Methods/design</ ...[more]

PMID: 31221206

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Project description:BackgroundBased on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication. Trauma to the abdominal wall can be reduced by improvements in suture technique as well as suture material. Several factors, such as stitch length, suture tension, elasticity, and tensile strength of the suture material are discussed and currently under investigation. A Swedish randomized controlled trial showed a significant reduction in the incisional hernia rate by shortening the stitch length. However, a non-elastic thread was used and follow-up ended after 12 months. Therefore, we designed a multicenter, international, double-blinded, randomized trial to analyze the influence of stitch length, using an elastic, extra-long term absorbable monofilament suture, on the long term clinical outcome of abdominal wall closure.MethodsIn total, 468 patients undergoing an elective, median laparotomy will be randomly allocated to either the short stitch or the long stitch suture technique for abdominal wall closure in a 1:1 ratio. Centers located in Germany and Austria will participate. The primary endpoint measure is the incisional hernia rate 1 year postoperatively, as verified by ultrasound. The frequency of short term and long term complications as well as costs, length of hospital stay and patients' quality of life (EQ-5D-5 L) will be considered as secondary parameters. Following hospital discharge, patients will be examined after 30 days and 1, 3, and 5 years after surgery.DiscussionThis study will provide further evidence on whether a short stitch suture technique in combination with an elastic, extra-long term absorbable monofilament suture can prevent incisional hernias in the long term, compared with the long stitch suture technique.Trial registrationNCT01965249 .

Project description:BACKGROUND:Laparoscopic repair of ventral and incisional hernias has gained popularity since many studies have reported encouraging results in terms of outcomee and recurrence. Choice of mesh and fixation methods are considered crucial issues in preventing recurrences and complications. Lightweight meshes are considered the first choice due to their biomechanical properties and the ability to integrate into the abdominal wall. Titanium helicoidal tacks still represent the "gold standard" for mesh fixation, even if they have been suggested to be involved in the genesis of post-operative pain and complications. Recently, absorbable tacks have been introduced, under the hypothesis that there will be no need to maintain a permanent fixation device after mesh integration. Nevertheless, there is no evidence that absorbable tacks may guarantee the same results as titanium tacks in terms of strength of fixation and recurrence rates. The primary end point of the present trial is to test the hypothesis that absorbable tacks are non-inferior to titanium tacks in laparoscopic incisional and ventral hernia repair (LIVHR) by lightweight polypropylene mesh, in terms of recurrence rates at 3-year follow-up. Surgical complications, post-operative stay, comfort and pain are secondary end points to be assessed. METHODS/DESIGN:Two hundred and twenty patients with ventral hernia will be randomized into 2 groups: Group A (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by titanium tacks; Group B (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by absorbable tacks. DISCUSSION:A few retrospective studies have reported similar results when comparing absorbable versus non-absorbable tacks in terms of intraoperative and early post-operative outcomes. These studies have the pitfalls to be retrospective evaluation of small series of patients, and the reported results still need to be validated by larger series and prospective studies. The aim of the present trial is to investigate and test the non-inferiority of absorbable versus non-absorbable tacks in terms of hernia recurrence rates, in order to assess whether the use of absorbable tacks may achieve the same results as non-absorbable tacks in mid-term and long-term settings. TRIAL REGISTRATION NUMBER:NCT02076984: 5 June 2014 (ClinicalTrials.gov).

Project description:IntroductionIncisional hernia (IH) is a common complication of abdominal surgery affecting between 10% and 20% of patients and is associated with significant morbidity along with cost to the National Health Service. With high recurrence rates following repair, focus must be on prevention of IH rather than cure. There is an increasing evidence that patients at high risk of developing IH may benefit from prophylactic mesh placement during their index operation. With recent controversy surrounding the use of mesh in the UK, however, there is little understanding of whether this intervention would be acceptable to patients.Methods and analysisINVITE is a mixed-methods, cross-sectional study to explore patient perceptions of the use of mesh as prophylaxis to prevent IH. Patients with and without IH who have undergone colorectal surgery between 2017 and 2020 in a single UK health-board will be approached to participate. 120 participants will be asked to complete a questionnaire and a subgroup of 24 participants will be invited to semistructured interviews. The primary outcome is to assess the acceptability of prophylactic mesh to patients. Secondary outcomes include understanding patients' knowledge of IH, and factors that may influence or alter the acceptability of mesh. Questionnaires have been developed using a 5-point Likert scale to allow quantitative analysis. Qualitative analysis of interviews will be conducted using NVivo software and thematic analysis. Data will be presented using the Journal Article Reporting Standards for mixed-methods research.Ethics and disseminationEthical approval has been granted by REC Wales (22/PR/0678), and the study is currently in setup. All participants will be required to provide informed consent prior to their participation in the study. We plan to report the results of the study in peer-reviewed scientific and medical journals and via presentations at scientific meetings. Results from this study will aid the design of interventional trials using prophylactic mesh.Trial registration numberNCT05384600.

Project description:BackgroundIncisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia.Methods/designThis clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial.DiscussionTo date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012.Trial registrationClinicalTrials.gov: NCT01349400.

Project description:BK virus infection has emerged as a major complication in kidney transplantation leading to a significant reduction in graft survival. There are currently no proven strategies to prevent or treat BK virus infection. Quinolone antibiotics, such as levofloxacin, have demonstrated activity against BK virus. We hypothesize that administration of a quinolone antibiotic, when given early post-transplantation, will prevent the establishment of BK viral replication in the urine and thus prevent systemic BK virus infection.The aim of this pilot trial is to assess the efficacy, safety and feasibility of a 3-month course of levofloxacin in the kidney transplant population. This is a multicenter, randomized, double-blind, placebo-controlled trial with two parallel arms conducted in 11 Canadian kidney transplant centers. A total of 154 patients with end-stage renal disease undergoing kidney transplantation will be randomized to receive a 3-month course of levofloxacin or placebo starting in the early post-transplant period. Levofloxacin will be administered at 500 mg po daily with dose adjustments based on kidney function. The primary outcome will be the time to occurrence of BK viruria within the first year post-transplantation. Secondary outcomes include BK viremia, measures of safety (adverse events, resistant infections,Clostridium difficile-associated diarrhea), measures of feasibility (proportion of transplanted patients recruited into the trial), proportion of patients adherent to the protocol, patient drop-out and loss to follow-up,and use of quinolone antibiotics outside of the trial protocol.Results from this pilot study will provide vital information to design and conduct a large, multicenter trial to determine if quinolone therapy decreases clinically meaningful outcomes in kidney transplantation. If levofloxacin significantly reduces BK viruria and urine viral loads in kidney transplantation, it will provide important justification to progress to the larger trial. If the full trial shows that levofloxacin significantly reduces BK infection and improves outcomes, its use in kidney transplantation will be strongly endorsed given the lack of proven therapies for this condition.This trial was funded by the Canadian Institutes of Health Research (grant number:222493) and is registered at ClinicalTrials.gov (NCT01353339).

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PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.

Publications

PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.

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