The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial (SONDES)

The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial

There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Colorectal Cancer; Anastomotic Leak; Anastomotic Complication
• Intervention / Treatment: Procedure: Intraoperative transanal decompression tube placement

Detailed Description

One of the complications of performing the colorectal anastomosis is the anastomotic leak, which sometimes entails the need for reinterventions and stoma formation (provisional or definitive). In recent decades, the improvement in surgical techniques together with the knowledge of the causes that predispose to the anastomotic failure have allowed to reduced the rates.

The placement of a tube probe through the anus in the postoperative period that decompresses the contents of the interior of the intestine (liquid or air) has been proposed as a factor that could influence the healing between intestines.

In studies carried out in other centers, with the same characteristics as the present one, differences have been shown in the probability of anastomotic leakage, but these results are not conclusive and do not allow us to know the effectiveness of this procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ander Timoteo, MD; Phone Number: +34972940256; Email: andertimoteo@gmail.com

Study Locations

• Spain
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Universitari Dr. Josep Trueta de Girona
    • Contact: Ander Timoteo, MD; Phone Number: 972940256; Email: andertimoteo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing scheduled laparoscopic, robotic or laparotomic colorectal cancer surgery who undergo colorectal anastomosis.
• Both mechanical and manual colorectal anastomosis with or without diverting ileostomy.
• Negative intraoperative air-leak test.
• Height of the anastomosis: promontory or distal to it.
• Age≥18 years.
• Histology of Adenocarcinoma with or without prior neoadjuvant treatment.
• Any T, any N, any M.
• Informed consent signed by the patient and by the researcher.

Exclusion Criteria:

• No performance of colorectal anastomosis.
• Colorectal tumor with histology other than adenocarcinoma or adenoma.
• Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of surgery.
• Inability to read or understand any of the informed consent languages (Catalan, Spanish).
• Emergency surgery.
• Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative transanal decompression tube placement; Intraoperatively under direct vision in the lower rectum, the balloon of the catheter will be inflated with 5-10cc of distilled water and it will be secured with a dressing / tape to the buttock connected to a collection bag.	Procedure: Intraoperative transanal decompression tube placement; Intraoperatively under direct vision in the lower rectum, the balloon of the catheter will be inflated with 5-10cc of distilled water and it will be secured with a dressing / tape to the buttock connected to a collection bag.
No Intervention: Non intraoperative transanal decompression tube placement; The usual postoperative care approved by the unit will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leakage rate between treatment arms	Anastomotic leakage (No/Yes), degree of anastomotic leakage (A, B or C), days of anastomotic leak diagnosis after colorectal surgery	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention rate	Reintervention due to any cause within 30 days after surgery	Within 30 days after surgery
Postoperative complication rate	Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as: Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.	Within 30 days after surgery
Definitive and / or temporary stoma rate after anastomotic leakage	Stoma formation due to anastomotic leak (No/Yes)	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): June 10, 2023
• Study Completion (Anticipated): July 10, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal cancer; Anastomotic leakage; Transanal tube emplacement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Anastomotic Leak; Postoperative Complications
• Other Study ID Numbers: 62019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No