Rectal CancerGECO1NCT04573621
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
A study testing Pelvic drain and No pelvic drain is placed in people with Rectal Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Pelvic drain and No pelvic drain is placed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2020to Sep 2022
- 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
- Male or Female, 18 year-of-age or above
- Mid or low rectal cancer
- Anastomosis below the peritoneal reflection
- Total mesorectal excision (TME)
- Capability to understand the study
- Informed consent
Who cannot join
- For women, pregnancy
- Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
- Life expectancy < 6 months
- Partial mesorectal excision
- Abdominoperineal excision
- Multivisceral resections
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain, 08035
Eloy Espín Basany, MD PhD, 934 893 000 ext. 6587, eespin@vhebron.net
About this study
Official title: Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.
Read the detailed description
This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:
- pelvic drain
- no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.
- Conditions
- Rectal Cancer
- Being tested
- Pelvic drain, No pelvic drain is placed
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic drainProcedure or surgery
A pelvic drain is placed
No pelvic drain is placedOther
A pelvic drain is not placed
| Study group | Role | What they receive |
|---|---|---|
| Pelvic drain | Active comparator | Placement of a pelvic drain Receives: Procedure: Pelvic drain |
| No pelvic drain | Experimental | No pelvic drain placed Receives: Other: No pelvic drain is placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pelvic sepsis
anastomotic leak or pelvic collections clinically or radiologically detected
Measured: 0-30 days postoperatively
Secondary outcomes (12)
Management of pelvic sepsis
Type of management (medical, rediological, surgical)
Measured: 0-30 days postoperatively
Postoperative complications
Overall postoperative complications
Measured: 0-30 days postoperatively
CT scan or imaging needed
Necessity of performing unscheduled imaging tests
Measured: 0-30 days postoperatively
Number of participants with postoperative ileus
Postoperative ileus
Measured: 0-30 days postoperatively
Diagnostic delay for a leak
Days between surgery and leak detection
Measured: 0-30 days postoperatively
Length of postperative stay
Days of stay after surgery
Measured: 0-30 days postoperatively or until discharge
Time to flatus and bowel movement
Days between surgery and flatus/faeces
Measured: 0-30 days postoperatively
Stoma presence at 1-year follow-up
Necessity of maintaining the diverting ileostomy at 1-year follow-up
Measured: 12 months after surgery
Late pelvic collections
Presence of pelvic collections detected at longer follow-up intervals
Measured: up to 60 days after surgery
Small bowel obstruction
Mechanical small bowel obstruction
Measured: up to 60 days after surgery
Quality of life associated with a drain
Visual Analogue Scale 0-10 (higher score means better outcome) score of postoperative pain and wound complaints
Measured: 30 days postoperatively
Any complications associated with drain removal after surgery
Safety of drain removal after surgery
Measured: up to 60 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 posted5 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 518 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573621
- Sponsor's protocol ID
- GECO1
- Acronym
- GECO1
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04573621
- Acronym / sponsor ID
- GECO1 / GECO1
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.
Detailed description
This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:
- pelvic drain
- no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic drain | Active comparator | Procedure: Pelvic drainPlacement of a pelvic drain |
| No pelvic drain | Experimental | Other: No pelvic drain is placedNo pelvic drain placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female, 18 year-of-age or above
- Mid or low rectal cancer
- Anastomosis below the peritoneal reflection
- Total mesorectal excision (TME)
- Capability to understand the study
Key exclusion criteria (7 listed)
- For women, pregnancy
- Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
- Life expectancy < 6 months
- Partial mesorectal excision
- Abdominoperineal excision
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 |
|---|---|---|
| Pelvic drainA pelvic drain is placed | Procedure or surgery | Pelvic drain |
| No pelvic drain is placedA pelvic drain is not placed | Other | No pelvic drain |
Primary outcome
Number of participants with pelvic sepsis
Time frame: 0-30 days postoperatively
anastomotic leak or pelvic collections clinically or radiologically detected
12 secondary outcomes
Management of pelvic sepsis
Time frame: 0-30 days postoperatively
Postoperative complications
Time frame: 0-30 days postoperatively
CT scan or imaging needed
Time frame: 0-30 days postoperatively
Number of participants with postoperative ileus
Time frame: 0-30 days postoperatively
Diagnostic delay for a leak
Time frame: 0-30 days postoperatively
Length of postperative stay
Time frame: 0-30 days postoperatively or until discharge
Time to flatus and bowel movement
Time frame: 0-30 days postoperatively
Stoma presence at 1-year follow-up
Time frame: 12 months after surgery
Late pelvic collections
Time frame: up to 60 days after surgery
Small bowel obstruction
Time frame: up to 60 days after surgery
Quality of life associated with a drain
Time frame: 30 days postoperatively
Any complications associated with drain removal after surgery
Time frame: up to 60 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 5 Oct 2020.
- Individual participant dataSharing planned: No
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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 Pelvic drain and No pelvic drain is placed in people with Rectal Cancer, run by Hospital Universitari Vall d'Hebron Research Institute 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 6 inclusion and 7 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 5 Oct 2020. 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 Eloy Espín-Basany (932746000 ext. 6587, eespin@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pelvic sepsis (time frame: 0-30 days postoperatively). 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 5 Oct 2020.