Colorectal CancerSONDESNCT04890015
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
A study testing Intraoperative transanal decompression tube placement in people with Colorectal Cancer and Postoperative Complications, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Postoperative Complications, Anastomotic Leak
- What is being tested?
- Intraoperative transanal decompression tube placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2017to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta de Girona
Girona, 17007
Ander Timoteo, MD, 972940256, andertimoteo@gmail.com
About this study
Official title: The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial
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.
Read the 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
- Being tested
- Intraoperative transanal decompression tube placement
- Keywords
- Colorectal cancer, Transanal tube emplacement, Anastomotic leakage
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative transanal decompression tube placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days after surgery
Secondary outcomes (3)
Reintervention rate
Reintervention due to any cause within 30 days after surgery
Measured: 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.
Measured: Within 30 days after surgery
Definitive and / or temporary stoma rate after anastomotic leakage
Stoma formation due to anastomotic leak (No/Yes)
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start10 Jul 2017
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ander Timoteo Delgado, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890015
- Sponsor's protocol ID
- 62019
- Acronym
- SONDES
- Status last verified
- Sep 2021
- First submitted
- 12 May 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04890015
- Acronym / sponsor ID
- SONDES / 62019
- Conditions
- Colorectal Cancer, Postoperative Complications, Anastomotic Leak, Anastomotic Complication
- Keywords
- Colorectal cancer, Transanal tube emplacement, Anastomotic leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Jul 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative transanal decompression tube placement | Experimental | Procedure: Intraoperative transanal decompression tube placementIntraoperatively 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 | No intervention | –The usual postoperative care approved by the unit will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative transanal decompression tube placementIntraoperatively 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 or surgery | Intraoperative transanal decompression tube placement |
Primary outcome
Anastomotic leakage rate between treatment arms
Time frame: Within 30 days after surgery
Anastomotic leakage (No/Yes), degree of anastomotic leakage (A, B or C), days of anastomotic leak diagnosis after colorectal surgery
3 secondary outcomes
Reintervention rate
Time frame: Within 30 days after surgery
Postoperative complication rate
Time frame: Within 30 days after surgery
Definitive and / or temporary stoma rate after anastomotic leakage
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative transanal decompression tube placement in people with Colorectal Cancer and Postoperative Complications, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ander Timoteo, MD (+34972940256, andertimoteo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage rate between treatment arms (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.