Rectal NeoplasmsACADNCT04248634
Evaluation of Delayed Coloanal Anastomosis
An observational study of Rectal Neoplasms, run by Institut National d'Oncologie, Morocco at 1 site in Morocco.
Trial summary
After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Delayed colo-anal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All consecutive patients aged above 18 years, who undergo rectal resection with the creation of delayed colo-anal anastomosis.
Who may be able to join
- Adult patients> 18 years old.
- Rectal resection with the creation of a delayed colo-anal anastomosis.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection
After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life.
Delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy.
In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.
Read the detailed description
After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. The latter reduces the risk and severity of clinical anastomotic fistulas. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity reaching up to 30% of patients, a deterioration in the quality of life and the need for a second surgery to restore digestive continuity. And specifically in low-income countries, ostomy bags are expensive and are not reimbursed, and therefore constitute a heavy burden for Moroccan patients.
In order to overcome these drawbacks, delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. This technique consists of externalizing the colon in the first stage by the transanal route, without creating an ileostomy, and waiting a week for the creation of the anastomosis. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy. Several studies have shown encouraging results in the short and midterm, and it is listed among the technical options in the French recommendations for the management of rectal cancer.
In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.
- Conditions
- Rectal Neoplasms
- Being tested
- Delayed colo-anal anastomosis
- Keywords
- Rectal neoplasmdelayed coloanal anastomosis, Ileostomy, Delayed coloanal anastomosis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed colo-anal anastomosisProcedure or surgery
Colo-anal anastomosis performed in two surgical steps:
- Step one: the colon is exteriorized transanally and 5 cm of the colon is left outside without anastomosis creation.
Step two: after 7 days, the excess colon is resected and the colo-anal anastomosis is created.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma rate at 90 days
The rate of patients who required a stoma creation at 90 days
Measured: 90 days
Perineal complications
Rates of perineal complications at 90 days after surgery
Measured: 90 days
Secondary outcomes (3)
Clavien-Dindo complications
Rate of complications according to Clavien-Dindo grading
Measured: 90 days
Functional outcomes
Continence score according to the Low anterior resection syndrom score (LARS). Score from 0 to 42 (0-20 No LARS / 21-29 Minor LARS / 30-42 Major LARS). Higher score indicates worse outcome
Measured: 12 months
Quality of life assessement: EORTC QLQ30 score
Quality of life using the EORTC QLQ30 score at 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National d'Oncologie, Morocco
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anass Majbar, Institut National d'Oncologie, Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248634
- Sponsor's protocol ID
- SCOD 1
- Acronym
- ACAD
- Status last verified
- Feb 2020
- First submitted
- 28 Jan 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under reasonable request, we would share individual patient dara
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection
- ClinicalTrials.gov ID
- NCT04248634
- Acronym / sponsor ID
- ACAD / SCOD 1
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal neoplasmdelayed coloanal anastomosis, Ileostomy, Delayed coloanal anastomosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National d'Oncologie, MoroccoOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Jan 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.
After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life.
Delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy.
In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.
Detailed description
After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. The latter reduces the risk and severity of clinical anastomotic fistulas. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity reaching up to 30% of patients, a deterioration in the quality of life and the need for a second surgery to restore digestive continuity. And specifically in low-income countries, ostomy bags are expensive and are not reimbursed, and therefore constitute a heavy burden for Moroccan patients.
In order to overcome these drawbacks, delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. This technique consists of externalizing the colon in the first stage by the transanal route, without creating an ileostomy, and waiting a week for the creation of the anastomosis. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy. Several studies have shown encouraging results in the short and midterm, and it is listed among the technical options in the French recommendations for the management of rectal cancer.
In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients aged above 18 years, who undergo rectal resection with the creation of delayed colo-anal anastomosis.
Key inclusion criteria (2 listed)
- Adult patients> 18 years old.
- Rectal resection with the creation of a delayed colo-anal anastomosis.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Delayed colo-anal anastomosisColo-anal anastomosis performed in two surgical steps: - Step one: the colon is exteriorized transanally and 5 cm of the colon is left outside without anastomosis creation. Step two: after 7 days, the excess colon is resected and the colo-anal anastomosis is created. | Procedure or surgery | – |
Primary outcome
Stoma rate at 90 days
Time frame: 90 days
The rate of patients who required a stoma creation at 90 days
Perineal complications
Time frame: 90 days
Rates of perineal complications at 90 days after surgery
3 secondary outcomes
Clavien-Dindo complications
Time frame: 90 days
Functional outcomes
Time frame: 12 months
Quality of life assessement: EORTC QLQ30 score
Time frame: 12 months
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 20 Feb 2020.
- Individual participant dataSharing planned: Undecided. Under reasonable request, we would share individual patient dara
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Institut National d'Oncologie, Morocco at 1 site in Morocco.
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 2 inclusion and 1 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 20 Feb 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 Morocco. 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 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?
Stoma rate at 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. 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 20 Feb 2020.