NCT04890015

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-10
• Primary completion: 2023-06-10
• Completion: 2023-07-10
• First posted: 2021-05-18
• Last updated: 2021-09-02

Locations

1 site across 1 country: Spain