Rectal CancerPROTECTNCT04357171
PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
A study testing Low anterior resection with protective loop ileostomy and Low anterior resection with protective loop transverse colostomy in people with Rectal Cancer, run by Russian Society of Colorectal Surgeons.
Trial summary
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate. This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Low anterior resection with protective loop ileostomy and Low anterior resection with protective loop transverse colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2012to 2 Feb 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mid- and low rectal cancer
- Age ≧ 18
- TME
- ASA ≦ 3
- No previous stoma formation
- Informed consent for participation
Who cannot join
- Patients lost during the follow-up
- Refusal of the patient from further participation in the study
- Inability of stoma formation
About this study
Official title: Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.
This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.
Read the detailed description
Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.
The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.
The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.
In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.
Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.
- Conditions
- Rectal Cancer
- Being tested
- Low anterior resection with protective loop ileostomy, Low anterior resection with protective loop transverse colostomy
- Keywords
- colostomy, ileostomy, rectal cancer, low anterior resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low anterior resection with protective loop ileostomyProcedure or surgery
Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.
Low anterior resection with protective loop transverse colostomyProcedure or surgery
Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.
| Study group | Role | What they receive |
|---|---|---|
| Ileostomy | Active comparator | Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection Receives: Procedure: Low anterior resection with protective loop ileostomy |
| Colostomy | Active comparator | Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection Receives: Procedure: Low anterior resection with protective loop transverse colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of readmissions due to severe dehydratation
The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting
Measured: 6 weeks
Secondary outcomes (5)
Early postoperative complications rate
The rate of all postoperative complications in early postoperative period after resectional surgery
Measured: 30 days after the initial procedure
Late postoperative complications rate
The rate of all postoperative complications
Measured: starting on 31st day and within 6 months in late postoperative period after the initial procedure
Overall quality of life
Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
Measured: 6 and 12 months after the initial procedure
Time with stoma
The period of time between initial resectional procedure and closure of protetctive stoma only in patients who had their intestinal stoma reversed
Measured: 5 years
The rate of early postoperative complications after stoma closure operation
The rate of early postoperative complications after stoma closure operation
Measured: 3 months after stoma closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start14 Jan 2012
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Principal investigator, Clinic of Colorectal and Minimally Invasive SurgeryInna Tulina, Study chair, Clinic of Colorectal and Minimally Invasive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357171
- Sponsor's protocol ID
- 5
- Acronym
- PROTECT
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04357171
- Acronym / sponsor ID
- PROTECT / 5
- Conditions
- Rectal Cancer
- Keywords
- colostomy, ileostomy, rectal cancer, low anterior resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 14 Jan 2012 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 22 Apr 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.
The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.
This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.
Detailed description
Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.
The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.
The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.
In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.
Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ileostomy | Active comparator | Procedure: Low anterior resection with protective loop ileostomyLoop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection |
| Colostomy | Active comparator | Procedure: Low anterior resection with protective loop transverse colostomyLoop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mid- and low rectal cancer
- Age ≧ 18
- TME
- ASA ≦ 3
- No previous stoma formation
Key exclusion criteria (3 listed)
- Patients lost during the follow-up
- Refusal of the patient from further participation in the study
- Inability of stoma formation
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 |
|---|---|---|
| Low anterior resection with protective loop ileostomyNerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed. | Procedure or surgery | Ileostomy |
| Low anterior resection with protective loop transverse colostomyNerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed. | Procedure or surgery | Colostomy |
Primary outcome
The rate of readmissions due to severe dehydratation
Time frame: 6 weeks
The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting
5 secondary outcomes
Early postoperative complications rate
Time frame: 30 days after the initial procedure
Late postoperative complications rate
Time frame: starting on 31st day and within 6 months in late postoperative period after the initial procedure
Overall quality of life
Time frame: 6 and 12 months after the initial procedure
Time with stoma
Time frame: 5 years
The rate of early postoperative complications after stoma closure operation
Time frame: 3 months after stoma closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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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.
Petr Tsarkov principal investigator
Clinic of Colorectal and Minimally Invasive Surgery
Inna Tulina study chair
Clinic of Colorectal and Minimally Invasive Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Low anterior resection with protective loop ileostomy and Low anterior resection with protective loop transverse colostomy in people with Rectal Cancer, run by Russian Society of Colorectal Surgeons.
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 3 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: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of readmissions due to severe dehydratation (time frame: 6 weeks). 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 22 Apr 2020.