CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Transanal Inspection and management of low ColoRectal Anastomosisprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879370
NCT02879370N/ACompleted

"Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique: the TICRANT Study"

University of Rome Tor Vergata·interventional·Posted Aug 25, 2016·Updated Oct 26, 2017

In Brief

A clinical study evaluating Transanal Inspection and management of low ColoRectal Anastomosis for Anastomotic Leak. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The technique the investigators propose to perform colorectal and colo-anal anastomosis in patients underwent low and ultra-low anterior resection for rectal cancer could potentially reduce the anastomotic leakage rate by better trans-anal introduction of the circular stapler, elimination of the previous suture lines and dog ears, combined with direct inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually direct repair of any small anastomotic defects. Another important point in cancer surgery is the easily identification of the distal margin. In fact, this technique is simple to perform, reproducible and safe in terms of complications.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartJan 1, 2013
Primary CompletionJan 1, 2016
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 9.9 years ago

Interventions

Transanal Inspection and management of low ColoRectal Anastomosisprocedure

Low anterior resection with total mesorectal excision (TME), either performed open, laparoscopic or robotic Closure of the rectum with linear or curved stapler with transanal inspection Transanal placement of four 2-0 prolene sutures on the rectal stump, respectively 2 at the extremities of the suture line (left and right) and other two 1 cm medial to each of the previous two sutures Circular stapler is introduced, the 4 tails of the prolene stitches are introduced through the windows (2 in the left and 2 in the right side of the instrument) and gently pulled, to obtain a gradual and homogeneous traction of the tissue and elimination of both previous suture lines and doggy ears, then the stapler is fired The termino-terminal anastomosis is carefully inspected A leak test can be performed (if negative the protective stoma is not performed) An eventual leak can be transanally repaired