Clinical trial · Interventional
Reinforcement of Rectal Anastomosis-RORA
RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system. Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences. The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemopatch | Device | — | UNRESOLVED |
| The rectal anastomosis will be reinforced with HemoPatch. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prospective pilot
- description
- Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.
- interventionNames
- Procedure: The rectal anastomosis will be reinforced with HemoPatch.
- Device: Hemopatch
Primary outcomes (1)
- measure
- Evidence of clinical anastomotic leak( elevated C reactive protein and white blood corpuscles, fever, nausea). Suspicion of a leak will be investigated with a Ct scan.
- timeFrame
- 10 days
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Rectal surgery with anastomosis below 10 cm from anal verge Exclusion Criteria: * none
References
Publications (3)
- RESULTBruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x. PMID 11531861
- RESULTDaams F, Luyer M, Lange JF. Colorectal anastomotic leakage: aspects of prevention, detection and treatment. World J Gastroenterol. 2013 Apr 21;19(15):2293-7. doi: 10.3748/wjg.v19.i15.2293. PMID 23613621
- RESULTDekker JW, Liefers GJ, de Mol van Otterloo JC, Putter H, Tollenaar RA. Predicting the risk of anastomotic leakage in left-sided colorectal surgery using a colon leakage score. J Surg Res. 2011 Mar;166(1):e27-34. doi: 10.1016/j.jss.2010.11.004. Epub 2010 Dec 1. PMID 21195424