Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Rectal Cancer Clinical Trial

— LessStoReS  

Official title:

Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02279771
• Other study ID #: Siccr/2014
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Donato F Altomare, MD
• Phone: 3397593066
• Email: donatofrancesco.altomare[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• transanal anastomotic reinforcement
a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired. Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.
• protective ileostomy group
S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.

Device:
• a circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Donato F Altomare

Country where clinical trial is conducted

Italy, 

References & Publications (20)

Altomare DF, Pannarale OC, Lupo L, Palasciano N, Memeo V, Rubino M. Protective colostomy closure: the hazards of a "minor" operation. Int J Colorectal Dis. 1990 May;5(2):73-8. — View Citation

Baek SJ, Kim J, Kwak J, Kim SH. Can trans-anal reinforcing sutures after double stapling in lower anterior resection reduce the need for a temporary diverting ostomy? World J Gastroenterol. 2013 Aug 28;19(32):5309-13. doi: 10.3748/wjg.v19.i32.5309. — View Citation

Bafford AC, Irani JL. Management and complications of stomas. Surg Clin North Am. 2013 Feb;93(1):145-66. doi: 10.1016/j.suc.2012.09.015. Review. — View Citation

Branagan G, Finnis D; Wessex Colorectal Cancer Audit Working Group. Prognosis after anastomotic leakage in colorectal surgery. Dis Colon Rectum. 2005 May;48(5):1021-6. — View Citation

Chiu A, Chan HT, Brown CJ, Raval MJ, Phang PT. Failing to reverse a diverting stoma after lower anterior resection of rectal cancer. Am J Surg. 2014 May;207(5):708-11; discussion 711. doi: 10.1016/j.amjsurg.2013.12.016. Epub 2014 Mar 12. — View Citation

Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17. Review. — View Citation

Cong 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. — View Citation

Fazio VW, Zutshi M, Remzi FH, Parc Y, Ruppert R, Fürst 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. — View Citation

Gastinger I, Marusch F, Steinert R, Wolff S, Koeckerling F, Lippert H; Working Group 'Colon/Rectum Carcinoma'. Protective defunctioning stoma in low anterior resection for rectal carcinoma. Br J Surg. 2005 Sep;92(9):1137-42. — View Citation

Gong 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. — View Citation

Heald 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. — View Citation

Karanjia 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. — View Citation

Matthiessen P, Hallböök O, Andersson M, Rutegård J, Sjödahl R. Risk factors for anastomotic leakage after anterior resection of the rectum. Colorectal Dis. 2004 Nov;6(6):462-9. — View Citation

Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. — View Citation

Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929. Review. — View Citation

Pérez Domínguez L, García Martínez MT, Cáceres Alvarado N, Toscano Novella A, Higuero Grosso AP, Casal Núñez JE. Morbidity and mortality of temporary diverting ileostomies in rectal cancer surgery. Cir Esp. 2014 Nov;92(9):604-8. doi: 10.1016/j.ciresp.2013.12.011. Epub 2014 Jun 23. English, Spanish. — View Citation

Rullier E, Laurent C, Garrelon JL, Michel P, Saric J, Parneix M. Risk factors for anastomotic leakage after resection of rectal cancer. Br J Surg. 1998 Mar;85(3):355-8. — View Citation

Senagore A, Lane FR, Lee E, Wexner S, Dujovny N, Sklow B, Rider P, Bonello J; Bioabsorbable Staple Line Reinforcement Study Group. Bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study. Dis Colon Rectum. 2014 Mar;57(3):324-30. doi: 10.1097/DCR.0000000000000065. — View Citation

Siegel 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. — View Citation

Testini M, Gurrado A, Portincasa P, Scacco S, Marzullo A, Piccinni G, Lissidini G, Greco L, De Salvia MA, Bonfrate L, Debellis L, Sardaro N, Staffieri F, Carratù MR, Crovace A. Bovine pericardium patch wrapping intestinal anastomosis improves healing process and prevents leakage in a pig model. PLoS One. 2014 Jan 29;9(1):e86627. doi: 10.1371/journal.pone.0086627. eCollection 2014. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leak	anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis	30 postoperative days
Secondary	duration of the two operations	the duration in minutes of the two types of operation	Intraoperative
Secondary	Number of overall postoperative complications		30 postoperative days