Colonic NeoplasmsNCT03746353
Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer
A study testing early ileostomy closure in people with Colonic Neoplasms and Ileostomy - Stoma, run by Instituto Nacional de Cancerologia, Columbia at 3 sites in Colombia.
Trial summary
Colorectal cancer worldwide is the third most common in men and the second in female, although mortality is not as high as its incidence, there is less survival in developing countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery
- What is being tested?
- early ileostomy closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesColombia
- Study dates
- 5 Sep 2018to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years Diagnosis of Rectal cancer treated at the National Institute of Cancerology and any of the institutions attached to the study
Who cannot join
- Complications derived from the anterior resection of the rectum:
- Unresolved intestinal obstruction
- Sepsis
- Organ or space type operative site infection
- Hemodynamic inestability
- Need for reinterventions due to complications
- Coagulopathy
- Active bleeding
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
Instituto Nacional de Cancerología
Bogota, Cundinamarca, 0000
Clinica Vida
Medellín
Hospital Pablo Tobón Uribe
Medellín
About this study
Official title: Early Closure of the Derivative Ileostomy Versus Conventional Closure in Postoperative Patients With Low Anterior Resection for Rectal Cancer
Colorectal cancer worldwide is the third most common in men and the second in female, although mortality is not as high as its incidence, there is less survival in developing countries. According to data from the World Health Organization, in 2012, there were an estimated 1.4 million cases and 693,900 deaths from this disease. Patients with rectal cancer are frequently taken to resection surgery as a curative management of their malignant pathology, according to the type of resection or reconstruction. In a high number of cases, they are management with colorectal anastomosis with a derivative ileostomy in the same procedure. The closure of this ileostomy is usually done after two to three months of the procedure, however in our environment it could take up to six or twelve months, during which time the patient is exposed to social difficulties, management problems and complications, derived from it. The early closure (7-12 days of its creation) of an ileostomy, despite the little evidence, seems to be a safe, feasible procedure that would save the patient having to live temporarily with an ileostomy.
Read the detailed description
General purpose:
To compare the frequency of perioperative complications and quality of life between early closure of the derivative ileostomy versus conventional closure in postoperative patients with low anterior resection for rectal cancer.
Materials and methods:
Controlled clinical trial, randomized, to be carried out at the National Cancer Institute of Colombia E.S.E. Eligible candidates for the study will be patients older than 18 years who have undergone a previous resection of the rectum plus a derivative ileostomy for colorectal cancer. All patients eligible for inclusion will undergo computed axial tomography with rectal contrast medium on postoperative day 5. Those who meet the inclusion criteria and do not present any of the exclusion criteria will enter the study, prior willingness to participate by part of the patient and obtaining verbal and written informed consent. Through computer-generated randomization, patients will undergo early closure (between 7 and 12 days after the ileostomy) versus conventional closure (after 90 days or more time from the creation of the ileostomy). A sample size of 81 patients was calculated for each arm. The follow-up will be done in both groups at 3, 6, 9 and 12 months after the creation of the ileostomy, including complications using the Clavien-Dindo classification and quality of life using the FACIT-C format. The statistical analysis will be done by protocol and intention to treat. The perioperative complications associated with the closure of the ileostomy, the complications associated with the presence of ileostomy, hospital stay, and quality of life will be analyzed.
Expected impact:
The investigators hope to find that the early closure of ileostomy in patients during the immediate postoperative period of previous resection due to rectal cancer is safe in terms of morbidity and mortality, feasible and with benefits in quality of life during the immediate postoperative period compared with patients to whom they are closed late (after 3 months).
- Conditions
- Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery
- Being tested
- early ileostomy closure
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early ileostomy closureProcedure or surgery
Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Early closure of ileostomy | Experimental | Early clousure of ileostomy before 30 days Receives: Procedure: early ileostomy closure |
| Conventional closure of ileostomy | Active comparator | Conventional closure of ileostomy after 30 days Receives: Procedure: early ileostomy closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative complications
To compare the frequency of perioperative complications and quality of life between early ( closure of the derivative ileostomy versus conventional closure in postoperative patients with low anterior resection for rectal cancer.
Using the Clavien-Dindo classification (It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life)
Measured: 6 yr
Secondary outcomes (2)
The follow-up for describe complications
Using the Clavien-Dindo classification (It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life)
Measured: 6 yr
Measure quality of life
Using the FACIT-C format (Version 4)
Measured: 6 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start5 Sep 2018
- Primary completion11 Nov 2019
- Study completion1 Jul 2020
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexander Carreño, Md, Study director, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746353
- Sponsor's protocol ID
- C190-10300-120
- Status last verified
- Sep 2020
- First submitted
- 31 Jul 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Closure of the Derivative Ileostomy Versus Conventional Closure in Postoperative Patients With Low Anterior Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT03746353
- Acronym / sponsor ID
- C190-10300-120
- Conditions
- Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 19 Nov 2018 (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.
Colorectal cancer worldwide is the third most common in men and the second in female, although mortality is not as high as its incidence, there is less survival in developing countries. According to data from the World Health Organization, in 2012, there were an estimated 1.4 million cases and 693,900 deaths from this disease. Patients with rectal cancer are frequently taken to resection surgery as a curative management of their malignant pathology, according to the type of resection or reconstruction. In a high number of cases, they are management with colorectal anastomosis with a derivative ileostomy in the same procedure. The closure of this ileostomy is usually done after two to three months of the procedure, however in our environment it could take up to six or twelve months, during which time the patient is exposed to social difficulties, management problems and complications, derived from it. The early closure (7-12 days of its creation) of an ileostomy, despite the little evidence, seems to be a safe, feasible procedure that would save the patient having to live temporarily with an ileostomy.
Detailed description
General purpose:
To compare the frequency of perioperative complications and quality of life between early closure of the derivative ileostomy versus conventional closure in postoperative patients with low anterior resection for rectal cancer.
Materials and methods:
Controlled clinical trial, randomized, to be carried out at the National Cancer Institute of Colombia E.S.E. Eligible candidates for the study will be patients older than 18 years who have undergone a previous resection of the rectum plus a derivative ileostomy for colorectal cancer. All patients eligible for inclusion will undergo computed axial tomography with rectal contrast medium on postoperative day 5. Those who meet the inclusion criteria and do not present any of the exclusion criteria will enter the study, prior willingness to participate by part of the patient and obtaining verbal and written informed consent. Through computer-generated randomization, patients will undergo early closure (between 7 and 12 days after the ileostomy) versus conventional closure (after 90 days or more time from the creation of the ileostomy). A sample size of 81 patients was calculated for each arm. The follow-up will be done in both groups at 3, 6, 9 and 12 months after the creation of the ileostomy, including complications using the Clavien-Dindo classification and quality of life using the FACIT-C format. The statistical analysis will be done by protocol and intention to treat. The perioperative complications associated with the closure of the ileostomy, the complications associated with the presence of ileostomy, hospital stay, and quality of life will be analyzed.
Expected impact:
The investigators hope to find that the early closure of ileostomy in patients during the immediate postoperative period of previous resection due to rectal cancer is safe in terms of morbidity and mortality, feasible and with benefits in quality of life during the immediate postoperative period compared with patients to whom they are closed late (after 3 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early closure of ileostomy | Experimental | Procedure: early ileostomy closureEarly clousure of ileostomy before 30 days |
| Conventional closure of ileostomy | Active comparator | Procedure: early ileostomy closureConventional closure of ileostomy after 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years Diagnosis of Rectal cancer treated at the National Institute of Cancerology and any of the institutions attached to the study
Key exclusion criteria (8 listed)
- Unresolved intestinal obstruction
- Sepsis
- Organ or space type operative site infection
- Hemodynamic inestability
- Need for reinterventions due to complications
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 |
|---|---|---|
| early ileostomy closureAssigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery | Procedure or surgery | Conventional closure of ileostomy, Early closure of ileostomy |
Primary outcome
perioperative complications
Time frame: 6 yr
To compare the frequency of perioperative complications and quality of life between early ( closure of the derivative ileostomy versus conventional closure in postoperative patients with low anterior resection for rectal cancer. Using the Clavien-Dindo classification (It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life)
2 secondary outcomes
The follow-up for describe complications
Time frame: 6 yr
Measure quality of life
Time frame: 6 yr
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Alexander Carreño, Md study director
Instituto Nacional de Cancerologia, Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early ileostomy closure in people with Colonic Neoplasms and Ileostomy - Stoma, run by Instituto Nacional de Cancerologia, Columbia at 3 sites in Colombia.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia. 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?
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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?
perioperative complications (time frame: 6 yr). 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 2020.