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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
Sponsor:
Information provided by (Responsible Party):
Donato F Altomare, Societa Italiana di Chirurgia ColoRettale

Brief 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

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: transanal anastomotic reinforcement Procedure: protective ileostomy group Device: a circular anal dilator (CAD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. anastomotic leak [ Time Frame: 30 postoperative days ]
    anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis


Secondary Outcome Measures :
  1. duration of the two operations [ Time Frame: Intraoperative ]
    the duration in minutes of the two types of operation

  2. Number of overall postoperative complications [ Time Frame: 30 postoperative days ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Donato F Altomare, MD 3397593066 donatofrancesco.altomare@uniba.it
Contact: Maria Di Lena, MD +390805592107 mariadilena@libero.it

Sponsors and Collaborators
Donato F Altomare

Publications:

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Responsible Party: Donato F Altomare, Associate professor, Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier: NCT02279771    
Other Study ID Numbers: Siccr/2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Donato F Altomare, Societa Italiana di Chirurgia ColoRettale:
colorectal anastomosis
anastomotic leak
ileostomy
complications
Additional relevant MeSH terms:
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Rectal Neoplasms
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes