Ileostomy Closure in Rectal CancerNCT02774447
Day-Case Closure of Loop Ileostomy in Rectal Cancer
An observational study of Ileostomy Closure in Rectal Cancer, run by Uppsala University at 1 site in Sweden.
Trial summary
The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileostomy Closure in Rectal Cancer
- What is being tested?
- ileostoma closure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Mar 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients earlier operated at the local hospital, who are now planned for closure of ileostomy
Who may be able to join
- Adults not older than 80 planed for closure of ileostomy
- The patient should not have had the ileostomy for more than 1 year
- Informed written consent should be given
- The patient should have a phone
- Should have an adult supervision at home for the first 24 hours after discharge
- American Society of Anesthesiologists (ASA) classification 1-2
Who cannot join
- ASA classification 3 and above
- The pre-operative investigation have shown anastomosis leakage or stricture
- Dementia or other cognitive dysfunction
- The need of an interpreter
- Patients assessed not being able to manage themselves at home post-operative
- Insulin treated diabetes
Show all 21Show fewer
- Coagulopathy
- Other organ dysfunction
- Bleeding more than 300 ml
- If converted to laparatomy
- Other intraoperative difficulties leading to suspected increased risk of complication
- Discharge criteria:
- Stable vital parameters regarding circulation and respiration
- No sign of bleeding
- Pain relief possible through per oral administration
- Emptied urinary bladder
- Able to maintain per oral nutrition
- Mobilization possible
- Obtained oral and written information about symptoms of sepsis and bowel obstruction
- Obtained telephone number of a contact-nurse
- Obtained time for wound-inspection at the surgical unit
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Landstinget Västmanland,Centrum för klinisk forskning
Västerås, 72189
About this study
Official title: Day-Case Closure of Ileostomy: A Pilot Study
The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.
Read the detailed description
For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.
- Conditions
- Ileostomy Closure in Rectal Cancer
- Being tested
- ileostoma closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileostoma closureProcedure or surgery
The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients with ileostoma | In association with anterior resection of rectal cancer these patients obtain loop-ileostoma in order to avoid complications. These are closed within a few months and according to previous studies the admission time is 3-5 days after operation. This study is a single-arm study. The arm include patients having had rectal cancer operation and who have obtained a loop-ileostoma and that meet the inclusion criteria.
The operation procedure is standardized; shortly described by dissecting the ileostoma from the abdominal wall and everting the stoma ledges, which will be sutured or stapled. The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will be followed up. Receives: Procedure: ileostoma closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complications
Measured: 30 days
Number of patients re-admitted
Measured: 30 days
Number of patients re-operated
Measured: 30 days
Number of patients who were able to return home after day-case closure of loop-ileostomy
Measured: 24 houres
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startAug 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy Closure in Rectal CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas Chabok, Phd, MD, Study director, Centrum for Clinical Research Västerås/Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774447
- Sponsor's protocol ID
- Dnr 2014/363
- Status last verified
- Apr 2020
- First submitted
- 28 Sep 2015
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Afshari K, Nikberg M, Smedh K, Chabok A. Loop-ileostomy reversal in a 23-h stay setting is safe with high patient satisfaction. Scand J Gastroenterol. 2021 Sep;56(9):1126-1130. doi: 10.1080/00365521.2021.1947367. Epub 2021 Jul 5.
PubMed 34224302
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day-Case Closure of Ileostomy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02774447
- Acronym / sponsor ID
- Dnr 2014/363
- Conditions
- Ileostomy Closure in Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 17 May 2016 (estimated)
- 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 aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.
Detailed description
For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients with ileostoma | – | Procedure: ileostoma closureIn association with anterior resection of rectal cancer these patients obtain loop-ileostoma in order to avoid complications. These are closed within a few months and according to previous studies the admission time is 3-5 days after operation. This study is a single-arm study. The arm include patients having had rectal cancer operation and who have obtained a loop-ileostoma and that meet the inclusion criteria. The operation procedure is standardized; shortly described by dissecting the ileostoma from the abdominal wall and everting the stoma ledges, which will be sutured or stapled. The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will be followed up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients earlier operated at the local hospital, who are now planned for closure of ileostomy
Key inclusion criteria (6 listed)
- Adults not older than 80 planed for closure of ileostomy
- The patient should not have had the ileostomy for more than 1 year
- Informed written consent should be given
- The patient should have a phone
- Should have an adult supervision at home for the first 24 hours after discharge
Key exclusion criteria (21 listed)
- ASA classification 3 and above
- The pre-operative investigation have shown anastomosis leakage or stricture
- Dementia or other cognitive dysfunction
- The need of an interpreter
- Patients assessed not being able to manage themselves at home post-operative
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 |
|---|---|---|
| ileostoma closureThe operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks. | Procedure or surgery | Rectal cancer patients with ileostoma |
Primary outcome
Number of patients with complications
Time frame: 30 days
Number of patients re-admitted
Time frame: 30 days
Number of patients re-operated
Time frame: 30 days
Number of patients who were able to return home after day-case closure of loop-ileostomy
Time frame: 24 houres
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 8 Apr 2020.
- Derived from this study: PubMed 34224302Afshari K, Nikberg M, Smedh K, Chabok A. Loop-ileostomy reversal in a 23-h stay setting is safe with high patient satisfaction. Scand J Gastroenterol. 2021 Sep;56(9):1126-1130. doi: 10.1080/00365521.2021.1947367. Epub 2021 Jul 5.
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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.
Abbas Chabok, Phd, MD study director
Centrum for Clinical Research Västerås/Uppsala University
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 Ileostomy Closure in Rectal Cancer, run by Uppsala University at 1 site in Sweden.
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 21 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 8 Apr 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 Sweden. 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?
Number of patients with complications (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774447, which also lists 1 linked publication.
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 8 Apr 2020.