Transanal Inspection and Management of Low ColoRectal Anastomosis Performed With a New Technique

NCT02879370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-10-26

No results posted yet for this study

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.

Conditions

  • Anastomotic Leak

Interventions

PROCEDURE

Transanal Inspection and management of low ColoRectal Anastomosis

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

Sponsors & Collaborators

  • San Giuseppe Moscati Hospital

    collaborator OTHER
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER
  • Casa di Cura San Pio X, Milano, Italy

    collaborator UNKNOWN
  • Policlinico Abano Terme

    collaborator OTHER
  • Ospedale Maggiore, Bologna Italy

    collaborator UNKNOWN
  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Francesco Crafa, MD · San Giuseppe Moscati Hospital

  • Giovanni Romano, MD · Fondazione G. Pascale

  • Jacques Megevand, MD · Pavia University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31
Completion
2017-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879370 on ClinicalTrials.gov