TreatmENT of AnastomotiC LeakagE after rectal cancer resection
Trial Overview
| Acronym | TENTACLE - Rectum |
|---|---|
| Number | NCT04127734 |
| Protocol Link | www.tentaclestudy.com/downloads |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT04127734 |
| Status | Open/recruiting |
| Category | Colorectal Cancer - Rectal Specific |
| Treatment Course | Surgery |
Trial Description
| The TENTACLE-Rectum study is an international collaborative retrospective cohort study investigating treatment of anastomotic leakage after low anterior resection (LAR). Factors contributing to the severity of anastomotic leakage will be identified to compose an evidence based anastomotic leakage severity score for different subgroups (e.g. early vs. late, diversion vs. no diversion, level of anastomosis, contamination). The effectiveness of different treatment approaches will be evaluated and |
Chief Investigator
|
Hans de Wilt prof. dr. |
| Profile Link |
Lead Centre
|
Radboud University Medical Center Nijmegen Geert Grooteplein-Zuid 10 Nijmegen 6525GA the Netherlands |
| Website |
Collaboration and Funding
Funding Sponsors
| 1. Radboudumc The Radboudumc supports the TENTACLE - Rectum financially and by contributing resources to the study, without influencing conduction of the study or study results. |
| 2. Radboudumc The Amsterdamumc supports the TENTACLE - Rectum financially and by contributing resources to the study, without influencing conduction of the study or study results. |
| 3. Medtronic inc The TENTACLE - Rectum is financially supported by Medtronic. Medtronic holds no rights over and cannot influence the conduction or results of the study. |
Additional Information
Full Research Summary| Objective: | Anastomotic leakage occurs in up to 20% after low anterior resection for rectal cancer. It is a severe complication with high associated morbidity, ICU admission, prolonged hospital stay and need for reinterventions and readmissions. Anastomotic leakage is independently associated with the risk of local recurrence and reduced long term survival. Most literature focusses on incidence and predictive factors. Remarkably, there is almost no data on the efficiency of different treatments of anastomotic leakage after low anterior resection. Anastomotic leakage after rectal cancer resection is generally underreported, mainly due to subclinical leaks below a diverting stoma. However, up to 50% of the leaks do not heal with fecal diversion alone, especially not in an irradiated field, related to a competent sphincter which hampers adequate drainage of the presacral abscess. Late diagnosis of ‘reactivated’ leaks after stoma reversal is not an infrequent phenomenon. Chronic sinus, gluteal abscess, and fistula formation have been reported in up to 10%, and permanent stoma rates around 20%, both having significant impact on quality of life. Examples of factors that may influence the severity and chance of healing of the anastomotic leakageare: timing of diagnosis, degree of systemic inflammatory response, etiology (e.g. ischemia of the fferent loop), degree of dehiscence and retraction, location of the leak (e.g. circular staple line, blind loop), whether or not a diverting stoma is in place, and extent of abdominal contamination. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity and chance of healing. In addition, it is not known which anastomoses are likely to be preserved by which type of treatment, and which anastomotic failures require redo surgery at a certain time frame. |
| Aim: | The TENTACLE - Rectum has 2 primary study objectives: 1. To investigate which factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score, in which clinically relevant subgroups will be explored (e.g. diversion or not), as well as different clinical settings (e.g. leak diagnosis within or beyond 90 days postoperatively). 2. To evaluate the effects of different treatment approaches on all different pre-specified outcome parameters, stratified for severity score, anatomical characteristics of leakages and timing of diagnosis of leakage. |
| Methods: | Study design: International multicenter retrospective cohort study. Data collection period: January 1st 2014 until December 31st 2018. Study population: Adult patients with anastomotic leakage after low anterior resection for rectal. Primary outcome parameter: 1-year stoma-free survival. Secondary outcome parameters: ICU length of stay, mortality, comprehensive complications index, total number of reinterventions (surgical, radiological, endoscopic) within one year, total number of unplanned readmissions within one year, total hospital stay during one year, total time of having a toma until one year, stoma present at one year, type of stoma present at one year (diverting, permanent), secondary leakage related complications (extrapelvic abscess, cutaneous fistula, vaginal fistula, bladder fistula, small bowel, ureteric fibrosis with hydronephrosis), hospital related costs. Sample size calculation: Inclusion of 1097 patients will be sufficient to analyze primary study objective 1 and this is 1246 patients for primary study objective 2. Therefore, the aim is to include at least 1246 patients. The full study protocol can be downloaded freely from www.tentaclestudy.com/downloads. |
| Reason for International Trial: | The large sample size needed, limited incidence and the broad international relevance of this problem are important reasons for the international collaborative design and retrospective character. In the future, we anticipate to perform prospective studies on the treatment of anastomotic leakage within the created network. |