NCT04890015

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

5.9 years

First QC Date

May 12, 2021

Last Update Submit

September 1, 2021

Conditions

Colorectal CancerPostoperative ComplicationsAnastomotic LeakAnastomotic Complication

Keywords

Colorectal cancerTransanal tube emplacementAnastomotic leakage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reintervention rate

    Within 30 days after surgery

  • Postoperative complication rate

    Within 30 days after surgery

  • Definitive and / or temporary stoma rate after anastomotic leakage

    Within 30 days after surgery

Study Arms (2)

Intraoperative transanal decompression tube placement

EXPERIMENTAL

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

Non intraoperative transanal decompression tube placement

NO INTERVENTION

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

Interventions

Intraoperative transanal decompression tube placementPROCEDURE

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.

Intraoperative transanal decompression tube placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17007, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative ComplicationsAnastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ander Timoteo, MD

CONTACT

+34972940256andertimoteo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General and digestive surgeon

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 18, 2021

Study Start

July 10, 2017

Primary Completion

June 10, 2023

Study Completion

July 10, 2023

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations

ES(1)