Clinical trial · Interventional
ReAL Trial (Rectal Anastomotic seaL)
Prevention of Anastomotic Leak in Colorectal Surgery by Glue Reinforcement. A Prospective Randomized Trial.
- 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 problem of anastomotic leak is particularly relevant in rectal surgery. Many risk factors have been recognized in the onset of this complication. Preventing the anastomotic leak can bring benefits to the patient and the health system. Several attempts have been proposed to reduce the risk of anastomotic leakage in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh. Cyanoacrylate (Glubran 2®) is a synthetic glue with sealing, adhesive and hemostatic properties widely used in surgery. The sealing effect creates an antiseptic barrier against bacteria. The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage
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 |
|---|---|---|---|
| Cyanoacrylate reinforcement | Procedure | — | UNRESOLVED |
| No reinforcement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cyanoacrylate
- description
- the anastomotic reinforcement with nebulized cyanoacrylate glue using the special short catheter device for open surgery or the laparoscopic catheter.
- interventionNames
- Procedure: Cyanoacrylate reinforcement
- type
- ACTIVE_COMPARATOR
- label
- No reinforcement
- description
- No reinforcement will be applied on the anastomosis line
- interventionNames
- Procedure: No reinforcement
Primary outcomes (1)
- measure
- Anastomotic leak
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable, histologically proven primary adenocarcinoma of the High-medium rectum without internal and/or external sphincter muscle involvement. * Distal margin of the tumor at least 8 cm form the anal verge * Staged as follows prior to neoadjuvant chemoradiation: Stage T2 - T4 at MRI * Patient classified T3-T4 will undergo neoadjuvant chemoradiation if the cancer is located in the extraperitoneal rectum Exclusion Criteria: * Squamous cell carcinoma * Adenocarcinoma Stage T1, * T4 with one of the following: with pelvic side wall involvement, requiring sacrectomy, requiring prostatectomy (partial or total) * Unresectable primary rectal cancer or Inability to complete R0 resection. * Rectal cancer under 8 cm from the anal verge requiring colo-anal or ultra low rectal anastomosis * Recurrent rectal cancer * Previous pelvic malignancy * Inability to sign the informed consent
References
Publications (7)
- RESULTThomas MS, Margolin DA. Management of Colorectal Anastomotic Leak. Clin Colon Rectal Surg. 2016 Jun;29(2):138-44. doi: 10.1055/s-0036-1580630. PMID 27247539
- RESULTde la Portilla F, Zbar AP, Rada R, Vega J, Cisneros N, Maldonado VH, Utrera A, Espinosa E. Bioabsorbable staple-line reinforcement to reduce staple-line bleeding in the transection of mesenteric vessels during laparoscopic colorectal resection: a pilot study. Tech Coloproctol. 2006 Dec;10(4):335-8. doi: 10.1007/s10151-006-0303-0. Epub 2006 Nov 27. PMID 17115313
- RESULTWiggins T, Markar SR, Arya S, Hanna GB. Anastomotic reinforcement with omentoplasty following gastrointestinal anastomosis: A systematic review and meta-analysis. Surg Oncol. 2015 Sep;24(3):181-6. doi: 10.1016/j.suronc.2015.06.011. Epub 2015 Jun 17. PMID 26116395
- RESULTBoersema GSA, Vennix S, Wu Z, Te Lintel Hekkert M, Duncker DGM, Lam KH, Menon AG, Kleinrensink GJ, Lange JF. Reinforcement of the colon anastomosis with cyanoacrylate glue: a porcine model. J Surg Res. 2017 Sep;217:84-91. doi: 10.1016/j.jss.2017.05.001. Epub 2017 May 10. PMID 28595813
- RESULTMontanaro L, Arciola CR, Cenni E, Ciapetti G, Savioli F, Filippini F, Barsanti LA. Cytotoxicity, blood compatibility and antimicrobial activity of two cyanoacrylate glues for surgical use. Biomaterials. 2001 Jan;22(1):59-66. doi: 10.1016/s0142-9612(00)00163-0. PMID 11085384
- RESULTWu Z, Boersema GS, Vakalopoulos KA, Daams F, Sparreboom CL, Kleinrensink GJ, Jeekel J, Lange JF. Critical analysis of cyanoacrylate in intestinal and colorectal anastomosis. J Biomed Mater Res B Appl Biomater. 2014 Apr;102(3):635-42. doi: 10.1002/jbm.b.33039. Epub 2013 Oct 24. PMID 24155114
- DERIVEDTomasicchio G, Martines G, Tartaglia N, Buonfantino M, Restini E, Carlucci B, Giove C, Dezi A, Ranieri C, Logrieco G, Vincenti L, Ambrosi A, Altomare DF, De Fazio M, Picciariello A. Suture reinforcement using a modified cyanoacrylate glue to prevent anastomotic leak in colorectal surgery: a prospective multicentre randomized trial : The Rectal Anastomotic seaL (ReAL) trial. Tech Coloproctol. 2024 Aug 5;28(1):95. doi: 10.1007/s10151-024-02967-7.