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The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage

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ClinicalTrials.gov Identifier: NCT03325361
Recruitment Status : Unknown
Verified October 2017 by Pierpaolo Sileri, University of Rome Tor Vergata.
Recruitment status was:  Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Pierpaolo Sileri, University of Rome Tor Vergata

Study Description
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Brief Summary:
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.

Condition or disease Intervention/treatment Phase
Rectal Cancer Rectal Neoplasms Anastomotic Leak Other: Tube drain insertion Not Applicable

Detailed Description:

Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.

Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: TD Other: Tube drain insertion
A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
No Intervention: NTD


Outcome Measures
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Primary Outcome Measures :
  1. Anastomotic leakage [ Time Frame: 30 days ]
    Prevention


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer

Exclusion Criteria:

  • No anastomosis
Contacts and Locations
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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): NCT03325361


Contacts
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Contact: Pierpaolo Sileri, PhD 3209353441 piersileri@yahoo.com
Contact: Mostafa Shalaby, PhD shalaby-mostafa@hotmail.com

Locations
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Italy
Policlinico Tor Vergata Hospital Recruiting
Rome, RM, Italy, 00133
Contact: Pierpaolo Sileri    3209353441      
Sponsors and Collaborators
University of Rome Tor Vergata
More Information
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Responsible Party: Pierpaolo Sileri, Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03325361    
Other Study ID Numbers: Transanal Tube Drainage
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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