Clinical trial · Interventional
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
- 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)
Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a circular anal dilator (CAD) | Device | — | UNRESOLVED |
| protective ileostomy group | Procedure | — | UNRESOLVED |
| transanal anastomotic reinforcement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- transanal anastomotic reinforcement
- description
- Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
- interventionNames
- Procedure: transanal anastomotic reinforcement
- Device: a circular anal dilator (CAD)
- type
- ACTIVE_COMPARATOR
- label
- protective ileostomy group
- description
- Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
- interventionNames
- Procedure: protective ileostomy group
Primary outcomes (1)
- measure
- anastomotic leak
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement. Distal margin of the tumor at least 6 cm form the anal verge Staged as follows prior to neoadjuvant chemoradiation: Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery 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 6 cm from the anal verge requiring colo-anal anastomosis * Recurrent rectal cancer * Previous pelvic malignancy * Inability to sign informed consent * Pregnancy
References
Publications (21)
- BACKGROUNDCong ZJ, Hu LH, Bian ZQ, Ye GY, Yu MH, Gao YH, Li ZS, Yu ED, Zhong M. Systematic review of anastomotic leakage rate according to an international grading system following anterior resection for rectal cancer. PLoS One. 2013 Sep 25;8(9):e75519. doi: 10.1371/journal.pone.0075519. eCollection 2013. PMID 24086552
- BACKGROUNDSiegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17. PMID 23335087
- BACKGROUNDHeald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019. PMID 6751457
- BACKGROUNDKaranjia ND, Corder AP, Bearn P, Heald RJ. Leakage from stapled low anastomosis after total mesorectal excision for carcinoma of the rectum. Br J Surg. 1994 Aug;81(8):1224-6. doi: 10.1002/bjs.1800810850. PMID 7953369
- BACKGROUNDFazio VW, Zutshi M, Remzi FH, Parc Y, Ruppert R, Furst A, Celebrezze J Jr, Galanduik S, Orangio G, Hyman N, Bokey L, Tiret E, Kirchdorfer B, Medich D, Tietze M, Hull T, Hammel J. A randomized multicenter trial to compare long-term functional outcome, quality of life, and complications of surgical procedures for low rectal cancers. Ann Surg. 2007 Sep;246(3):481-8; discussion 488-90. doi: 10.1097/SLA.0b013e3181485617. PMID 17717452
- BACKGROUNDMatthiessen P, Hallbook O, Andersson M, Rutegard J, Sjodahl R. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis. 2004 Nov;6(6):462-9. doi: 10.1111/j.1463-1318.2004.00657.x. PMID 15521937
- BACKGROUNDGong JP, Yang L, Huang XE, Sun BC, Zhou JN, Yu DS, Zhou X, Li DZ, Guan X, Wang DF. Outcomes based on risk assessment of anastomotic leakage after rectal cancer surgery. Asian Pac J Cancer Prev. 2014;15(2):707-12. doi: 10.7314/apjcp.2014.15.2.707.