Ileostomy, Rectal CancerNCT03796702
Early Versus Late Closure of Preventive Ileostomy
A study testing Deileostomy in people with Ileostomy, Rectal Cancer, run by Vilnius University at 1 site in Lithuania.
Trial summary
The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy, Rectal Cancer
- What is being tested?
- Deileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Nov 2011to 30 Dec 2018
- 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 with temporary ileostomy after rectal resection for rectal cancer
- Patients willing to participate in the study
Who cannot join
- Anastomosis insufficiency detected clinically or radiologically.
- Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
- Conditions
- Ileostomy, Rectal Cancer
- Being tested
- Deileostomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeileostomyProcedure or surgery
Deileostomy
| Study group | Role | What they receive |
|---|---|---|
| Early closure of preventive ileostomy | Experimental | A preventive ileostomy is closed 30 days after the primary surgery Receives: Procedure: Deileostomy |
| Late closure of preventive ileostomy | Experimental | A preventive ileostomy is closed 90 days after the primary surgery Receives: Procedure: Deileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 30 days after surgery
Secondary outcomes (3)
Hospitalization time after ileostomy closure
Hospitalization time
Measured: 30 days after surgery
30-days re-admission rate
Re-admission rate during 30 days after re-admission
Measured: 30 days after surgery
Quality of life of patients after ileostomy closure
Patients quality of life is assessed with EORTC QLQ-C30 questionnaires
Measured: at 3, 6, 9 and 12 moths after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Nov 2011
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Why it stopped: High postoperative morbidity rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy, 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rimantas Bausys, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796702
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2018
- Last updated
- 26 Apr 2023
- Results posted
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Closure of Preventive Ileostomy
- ClinicalTrials.gov ID
- NCT03796702
- Acronym / sponsor ID
- 1
- Conditions
- Ileostomy, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High postoperative morbidity rate
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 Jan 2019 (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 study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early closure of preventive ileostomy | Experimental | Procedure: DeileostomyA preventive ileostomy is closed 30 days after the primary surgery |
| Late closure of preventive ileostomy | Experimental | Procedure: DeileostomyA preventive ileostomy is closed 90 days after the primary surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with temporary ileostomy after rectal resection for rectal cancer
- Patients willing to participate in the study
Key exclusion criteria (2 listed)
- Anastomosis insufficiency detected clinically or radiologically.
- Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
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 |
|---|---|---|
| DeileostomyDeileostomy | Procedure or surgery | Early closure of preventive ileostomy, Late closure of preventive ileostomy |
Primary outcome
Postoperative morbidity
Time frame: 30 days after surgery
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
3 secondary outcomes
Hospitalization time after ileostomy closure
Time frame: 30 days after surgery
30-days re-admission rate
Time frame: 30 days after surgery
Quality of life of patients after ileostomy closure
Time frame: at 3, 6, 9 and 12 moths after surgery
Results and safety
The study was stopped early (reason given: High postoperative morbidity rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- 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.
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?
A study testing Deileostomy in people with Ileostomy, Rectal Cancer, run by Vilnius University at 1 site in Lithuania.
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 2 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 26 Apr 2023. 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 Lithuania. 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: High postoperative morbidity rate). 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?
Postoperative morbidity (time frame: 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 26 Apr 2023.