Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery (LessStoReS)
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|ClinicalTrials.gov Identifier: NCT02279771|
Recruitment Status : Unknown
Verified October 2014 by Donato F Altomare, Societa Italiana di Chirurgia ColoRettale.
Recruitment status was: Not yet recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: transanal anastomotic reinforcement Procedure: protective ileostomy group Device: a circular anal dilator (CAD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
Active Comparator: transanal anastomotic reinforcement
Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
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.
Device: a circular anal dilator (CAD)
Epo Flier, SapiMed SPA, Alessandria, Italy
Active Comparator: protective ileostomy group
Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)
Procedure: 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.
- anastomotic leak [ Time Frame: 30 postoperative days ]anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
- duration of the two operations [ Time Frame: Intraoperative ]the duration in minutes of the two types of operation
- Number of overall postoperative complications [ Time Frame: 30 postoperative days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279771
|Contact: Donato F Altomare, MDemail@example.com|
|Contact: Maria Di Lena, MDfirstname.lastname@example.org|