Back to resultsThe Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial (SONDES)
Primary Purpose
Colorectal Cancer, Postoperative Complications, Anastomotic Leak
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intraoperative transanal decompression tube placement
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal cancer, Transanal tube emplacement, Anastomotic leakage
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.
Sites / Locations
- Hospital Universitari Dr. Josep Trueta de GironaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intraoperative transanal decompression tube placement
Non intraoperative transanal decompression tube placement
Arm Description
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.
The usual postoperative care approved by the unit will be followed.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Reintervention rate
Reintervention due to any cause within 30 days after surgery
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.
Definitive and / or temporary stoma rate after anastomotic leakage
Stoma formation due to anastomotic leak (No/Yes)
Full Information
NCT ID
NCT04890015
First Posted
May 12, 2021
Last Updated
September 1, 2021
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
1. Study Identification
Unique Protocol Identification Number
NCT04890015
Brief Title
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
Acronym
SONDES
Official Title
The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Postoperative Complications, Anastomotic Leak, Anastomotic Complication
Keywords
Colorectal cancer, Transanal tube emplacement, Anastomotic leakage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative transanal decompression tube placement
Arm Type
Experimental
Arm Description
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.
Arm Title
Non intraoperative transanal decompression tube placement
Arm Type
No Intervention
Arm Description
The usual postoperative care approved by the unit will be followed.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative transanal decompression tube placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anastomotic leakage rate between treatment arms
Description
Anastomotic leakage (No/Yes), degree of anastomotic leakage (A, B or C), days of anastomotic leak diagnosis after colorectal surgery
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Reintervention rate
Description
Reintervention due to any cause within 30 days after surgery
Time Frame
Within 30 days after surgery
Title
Postoperative complication rate
Description
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.
Time Frame
Within 30 days after surgery
Title
Definitive and / or temporary stoma rate after anastomotic leakage
Description
Stoma formation due to anastomotic leak (No/Yes)
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ander Timoteo, MD
Phone
+34972940256
Email
andertimoteo@gmail.com
Facility Information:
Facility Name
Hospital Universitari Dr. Josep Trueta de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ander Timoteo, MD
Phone
972940256
Email
andertimoteo@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
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