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

NCT ID: NCT04890015

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2023-07-10

Brief 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.

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.

Conditions

Colorectal Cancer; Postoperative Complications; Anastomotic Leak; Anastomotic Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraoperative transanal decompression tube placement

Intervention Type: PROCEDURE

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.

Non intraoperative transanal decompression tube placement

The usual postoperative care approved by the unit will be followed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role: lead

Responsible Party

Ander Timoteo Delgado

General and digestive surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitari Dr. Josep Trueta de Girona

Girona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ander Timoteo, MD

Role: CONTACT

andertimoteo@gmail.com

+34972940256

Facility Contacts

Ander Timoteo, MD

Role: primary

andertimoteo@gmail.com

972940256

Other Identifiers

62019

Identifier Type: -

Identifier Source: org_study_id