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

Colorectal Cancer Clinical Trial

— SONDES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890015
• Other study ID #: 62019
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: July 10, 2023

Study information

• Verified date: September 2021
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Ander Timoteo, MD
• Phone: +34972940256
• Email: andertimoteo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: July 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Complication
• Anastomotic Leak
• Colorectal Cancer
• Colorectal Neoplasms
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta de Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reintervention rate	Reintervention due to any cause within 30 days after surgery	Within 30 days after surgery
Secondary	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
Secondary	Definitive and / or temporary stoma rate after anastomotic leakage	Stoma formation due to anastomotic leak (No/Yes)	Within 30 days after surgery