Colon CancerNCT01071824
Comparison of Limb Size of Transverse Coloplasty Pouch
A study testing Transverse coloplasty pouch (Long limb) and Transverse coloplasty pouch (Short limb) in people with Colon Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Transverse coloplasty pouch (Long limb) and Transverse coloplasty pouch (Short limb)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Dec 2023
- 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
- all patients in need of rectal resection due to benign or malign disease
- >=18 years
Who cannot join
- anamnestic rectal resection
- life expectancy of less than 2 years
- pregnancy
- <18 years
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
KS Liestal
Liestal, Basel-Landschaft, 4410
Christoph A. Maurer, Prof., +41619252150, christoph.maurer@ksli.ch
Christoph A. Maurer, Prof MD
About this study
Official title: Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision
The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.
Read the detailed description
No detailed description necessary, see brief summary.
- Conditions
- Colon Cancer
- Being tested
- Transverse coloplasty pouch (Long limb), Transverse coloplasty pouch (Short limb)
- Keywords
- size, limb, transverse coloplasty pouch, rectal resection, mesorectal excision, treatment outcome
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse coloplasty pouch (Long limb)Procedure or surgery
Transverse coloplasty pouch with long limb
Transverse coloplasty pouch (Short limb)Procedure or surgery
Transverse coloplasty pouch with short limb
| Study group | Role | What they receive |
|---|---|---|
| Transverse coloplasty pouch (Short limb) | Active comparator | The short limb is the standard technique of transverse coloplasty pouch. Receives: Procedure: Transverse coloplasty pouch (Short limb) |
| Transverse coloplasty pouch (Long limb) | Experimental | The long limb relates to straight coloanal anastomosis. Receives: Procedure: Transverse coloplasty pouch (Long limb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch function 4 month after closure of protective ileostomy.
Measured: 4 month
Secondary outcomes (1)
Pouch function 2 and 12 month respectively after closure of protective ileostomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph A. Maurer, MD, Kantonsspital Liestal
- Investigators
- Christoph A Maurer, Prof, Principal investigator, Kantonsspital Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071824
- Sponsor's protocol ID
- 303/08
- Status last verified
- Aug 2019
- First submitted
- 18 Feb 2010
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT01071824
- Acronym / sponsor ID
- 303/08
- Conditions
- Colon Cancer
- Keywords
- size, limb, transverse coloplasty pouch, rectal resection, mesorectal excision, treatment outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Feb 2010 (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 the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.
Detailed description
No detailed description necessary, see brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transverse coloplasty pouch (Short limb) | Active comparator | Procedure: Transverse coloplasty pouch (Short limb)The short limb is the standard technique of transverse coloplasty pouch. |
| Transverse coloplasty pouch (Long limb) | Experimental | Procedure: Transverse coloplasty pouch (Long limb)The long limb relates to straight coloanal anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients in need of rectal resection due to benign or malign disease
- >=18 years
Key exclusion criteria (5 listed)
- anamnestic rectal resection
- life expectancy of less than 2 years
- pregnancy
- <18 years
- missing informed consent
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 |
|---|---|---|
| Transverse coloplasty pouch (Long limb)Transverse coloplasty pouch with long limb | Procedure or surgery | Transverse coloplasty pouch (Long limb) |
| Transverse coloplasty pouch (Short limb)Transverse coloplasty pouch with short limb | Procedure or surgery | Transverse coloplasty pouch (Short limb) |
Primary outcome
Pouch function 4 month after closure of protective ileostomy.
Time frame: 4 month
1 secondary outcome
Pouch function 2 and 12 month respectively after closure of protective ileostomy.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Christoph A Maurer, Prof principal investigator
Kantonsspital Liestal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse coloplasty pouch (Long limb) and Transverse coloplasty pouch (Short limb) in people with Colon Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Aug 2019. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph A. Maurer, Prof. (+41619252150, christoph.maurer@ksli.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pouch function 4 month after closure of protective ileostomy. (time frame: 4 month). 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 15 Aug 2019.