Clinical trial NCT04890015: The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
Official title: The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Postoperative Complications
Anastomotic Leak
Anastomotic Complication
Keywords: Colorectal cancer
Transanal tube emplacement
Anastomotic leakage
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Anastomotic leakage rate between treatment arms
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Reintervention rate
timeFrame: Within 30 days after surgery
measure: Postoperative complication rate
timeFrame: Within 30 days after surgery
measure: Definitive and / or temporary stoma rate after anastomotic leakage
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
Study officials:
References: