Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
NCT ID: NCT02279771
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2015-01-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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transanal anastomotic reinforcement
Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
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.
a circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy
protective ileostomy group
Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
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.
Interventions
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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.
a circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy
Eligibility Criteria
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Inclusion Criteria
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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Donato F Altomare
NETWORK
Responsible Party
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Donato F Altomare
Associate professor
Principal Investigators
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Arcangelo Picciariello, MD
Role: PRINCIPAL_INVESTIGATOR
Societa Italiana di Chirurgia ColoRettale
Locations
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Bari, , Italy
Countries
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Central Contacts
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References
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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.
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.
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. doi: 10.1002/bjs.1800691019.
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. doi: 10.1002/bjs.1800810850.
Fazio 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.
Matthiessen 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.
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. doi: 10.7314/apjcp.2014.15.2.707.
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. doi: 10.1046/j.1365-2168.1998.00615.x.
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.
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. doi: 10.1007/s10350-004-0869-4.
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, Carratu 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.
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.
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.
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. doi: 10.1002/bjs.5045.
Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl 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. doi: 10.1097/SLA.0b013e3180603024.
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.
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.
Perez Dominguez L, Garcia Martinez MT, Caceres Alvarado N, Toscano Novella A, Higuero Grosso AP, Casal Nunez 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.
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. doi: 10.1007/BF00298472.
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.
Altomare DF, Delrio P, Shelgyn Y, Rybakov E, Vincenti L, De Fazio M, Simone M, Graziano G, Picciariello A. Transanal reinforcement of low rectal anastomosis versus protective ileostomy after total mesorectal excision for rectal cancer. Preliminary results of a randomized clinical trial. Colorectal Dis. 2021 Jul;23(7):1814-1823. doi: 10.1111/codi.15685. Epub 2021 May 10.
Other Identifiers
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Siccr/2014
Identifier Type: -
Identifier Source: org_study_id
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