Ulcerative ColitisTTSS-PouchNCT06331637
Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis
An observational study of Ulcerative Colitis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Transanal Transection and Single-Stapled anastomosis (TTSS) and Double-stapled anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will include adult patients diagnosed with drug-refractory and/or steroid-dependent Ulcerative Colitis (UC), scheduled for pouch surgery with double-stapled or Transanal Transection and Single-Stapled (TTSS) approach.
Who may be able to join
- Adult (≥ 18 years old) patients diagnosed with drug-refractory and/or steroid-dependent UC scheduled for elective restorative proctectomy.
- Patients scheduled for robotic or laparoscopic surgery
Who cannot join
- Planned open surgery.
- Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, 02 8224 7776 ext. 0039, colorapp@humanitas.it
Stefano De Zanet, MS, 02 8224 4623 ext. 0039, colorapp@humanitas.it
About this study
Official title: Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)
Read the detailed description
Ileal Pouch-Anal Anastomosis (IPAAI in Ulcerative Colitis (UC) patients is usually performed by double-stapling technique after rectal transection with a linear stapler. Double-stapling is increasingly criticized for the uneven longer cuffs and potential weak points. The Transanal Transection and Single-Stapled (TTSS) approach may potentially overcome the limitations of double-stapling. A single-stapled anastomosis may be accomplished through a transanal rectal transection followed by bottom-up dissection (transanal-ileal pouch-anal anastomosis) or through an abdominal, rectal dissection and subsequent transanal transection and single-stapled anastomosis. TTSS-IPAA approach was shown to provide reduced rectal cuff length and reduced rate of urgency at six months after stoma closure. However, the retrospective and single-center features of these findings may prevent a robust conclusion about the superiority of TTSS-IPAA. The purpose of this study is to compare short-term and functional outcomes of double-stapling versus TTSS techniques for IPAA in UC patients in a prospective multicentric cohort study.
- Conditions
- Ulcerative Colitis
- Being tested
- Transanal Transection and Single-Stapled anastomosis (TTSS), Double-stapled anastomosis
- Keywords
- Ileal Pouch-Anal Anastomosis, Intestinal Function
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal Transection and Single-Stapled anastomosis (TTSS)Procedure or surgery
Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)
Double-stapled anastomosisProcedure or surgery
Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)
| Study group | Role | What they receive |
|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | Patients will undergo restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal anastomosis (IPAA) Receives: Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS) | |
| Double-stapled anastomosis | Patients will undergo restorative proctectomy with double-stapled Ileal Pouch-Anal anastomosis (IPAA) Receives: Procedure: Double-stapled anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch Function Score (PFS)
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Measured: 6 months after surgery or stoma closure
Secondary outcomes (8)
Pouch Function Score (PFS)
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Measured: 12 months after surgery or stoma closure
Pouch Function Score (PFS)
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Measured: 24 months after surgery or stoma closure
Postoperative complications
Rate difference of postoperative complications, classified according to the Clavien-Dindo scale [ranging from 0 (no complications) to 5 (complications leading to death)] between the study cohorts
Measured: 90 days after surgery
Anastomotic leak
Rate difference of anastotic leaks between the study cohorts
Measured: 90 days after surgery
Patients fit for stoma closure
Proportion difference of patients fit for stoma closure in the study cohorts. Patients fit for stoma closure have already closed the stoma or have an intact anastomosis as demonstrated by a water contrast enema, Computed Tomography (CT) scan, endoscopic, or surgical revision
Measured: 12 months after surgery
Healthcare costs
Median difference of healthcare costs (direct and indirect) between the study cohorts
Measured: 12 months after surgery
Rectal cuff lenght
Median difference of rectal cuff lenght (in cm) between the study cohorts
Measured: At surgery
Pouch complications
Incidence rate difference of pouch complications or defunction- defined as any condition affecting the pouch function or requiring the pouch breakdown, including acute or chronic pouchitis, cuffitis, Crohn's disease of the pouch, or any other inflammatory condition - between the study cohorts.
Measured: 24 months after surgery or stoma closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331637
- Sponsor's protocol ID
- 3782
- Acronym
- TTSS-Pouch
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT06331637
- Acronym / sponsor ID
- TTSS-Pouch / 3782
- Conditions
- Ulcerative Colitis
- Keywords
- Ileal Pouch-Anal Anastomosis, Intestinal Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Mar 2024 (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.
This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)
Detailed description
Ileal Pouch-Anal Anastomosis (IPAAI in Ulcerative Colitis (UC) patients is usually performed by double-stapling technique after rectal transection with a linear stapler. Double-stapling is increasingly criticized for the uneven longer cuffs and potential weak points. The Transanal Transection and Single-Stapled (TTSS) approach may potentially overcome the limitations of double-stapling. A single-stapled anastomosis may be accomplished through a transanal rectal transection followed by bottom-up dissection (transanal-ileal pouch-anal anastomosis) or through an abdominal, rectal dissection and subsequent transanal transection and single-stapled anastomosis. TTSS-IPAA approach was shown to provide reduced rectal cuff length and reduced rate of urgency at six months after stoma closure. However, the retrospective and single-center features of these findings may prevent a robust conclusion about the superiority of TTSS-IPAA. The purpose of this study is to compare short-term and functional outcomes of double-stapling versus TTSS techniques for IPAA in UC patients in a prospective multicentric cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | – | Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS)Patients will undergo restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal anastomosis (IPAA) |
| Double-stapled anastomosis | – | Procedure: Double-stapled anastomosisPatients will undergo restorative proctectomy with double-stapled Ileal Pouch-Anal anastomosis (IPAA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients diagnosed with drug-refractory and/or steroid-dependent Ulcerative Colitis (UC), scheduled for pouch surgery with double-stapled or Transanal Transection and Single-Stapled (TTSS) approach.
Key inclusion criteria (2 listed)
- Adult (≥ 18 years old) patients diagnosed with drug-refractory and/or steroid-dependent UC scheduled for elective restorative proctectomy.
- Patients scheduled for robotic or laparoscopic surgery
Key exclusion criteria (2 listed)
- Planned open surgery.
- Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
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 |
|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS)Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA) | Procedure or surgery | Transanal Transection and Single-Stapled anastomosis (TTSS) |
| Double-stapled anastomosisRestorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA) | Procedure or surgery | Double-stapled anastomosis |
Primary outcome
Pouch Function Score (PFS)
Time frame: 6 months after surgery or stoma closure
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
8 secondary outcomes
Pouch Function Score (PFS)
Time frame: 12 months after surgery or stoma closure
Pouch Function Score (PFS)
Time frame: 24 months after surgery or stoma closure
Postoperative complications
Time frame: 90 days after surgery
Anastomotic leak
Time frame: 90 days after surgery
Patients fit for stoma closure
Time frame: 12 months after surgery
Healthcare costs
Time frame: 12 months after surgery
Rectal cuff lenght
Time frame: At surgery
Pouch complications
Time frame: 24 months after surgery or stoma closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Antonino Spinelli, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
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 Ulcerative Colitis, run by Istituto Clinico Humanitas at 1 site in Italy.
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: opening soon, as of the sponsor's last update on 26 Mar 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (02 8224 7776 ext. 0039, colorapp@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pouch Function Score (PFS) (time frame: 6 months after surgery or stoma closure). 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 Mar 2024.