Rectal CancerTTSS-RECNCT06314646
Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients
An observational study of Rectal Cancer and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- Transanal Transection and Single-Stapled anastomosis (TTSS) and Double-stapled Total Mesorectal Excision (TME)
- Type of treatment
- Surgery or procedure
- How many people
- 472 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2024to 31 Dec 2027
- 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 rectal cancer scheduled for elective rectal resection with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS).
Who may be able to join
- Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches.
- Patients scheduled for open, laparoscopic, or robotic surgery.
- Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma.
Who cannot join
- Immediate or delayed hand-sewn coloanal anastomosis.
- Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
- Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.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, 1 recruiting
- Recruiting
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 Long-term Outcomes of Transanal Tran-section and Single-stapled Anastomosis (TTSS) in Rectal Can-cer Patients: a Multicentric International IDEAL Stage 2b Prospective Parallel Cohort Study
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.
Read the detailed description
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique has become a valid alternative to the standard double-stapled anastomosis approach in the surgical treatment of low rectal cancer. Recent evidence showed a significantly reduced number of anastomotic leaks in patients undergoing TTSS compared with patients receiving double-stapled anastomosis, suggesting that TTSS may be technically feasible and may provide a surgical advantage over the traditional double-stapled technique. However, these studies were severely limited by their single-center and retrospective nature. This study aims to confirm the retrospective findings by extending the data collection to additional countries and provide prospective data collection.
- Conditions
- Rectal Cancer, Surgery
- Being tested
- Transanal Transection and Single-Stapled anastomosis (TTSS), Double-stapled Total Mesorectal Excision (TME)
- Keywords
- Rectal Cancer, Transanal Transection and Single-Stapled anastomosis, Total Mesorectal Excision
- Medical subject headings
- Rectal Neoplasms
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
Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
Double-stapled Total Mesorectal Excision (TME)Procedure or surgery
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)
| Study group | Role | What they receive |
|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | Patients will undergo rectal cancer surgery through low rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS) Receives: Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS) | |
| Double-stapled Total Mesorectal Excision (TME) | Patients will undergo rectal cancer surgery through low rectal resection with double-stapled anastomosis Total Mesorectal Excision (TME) Receives: Procedure: Double-stapled Total Mesorectal Excision (TME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic leak
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
Measured: 90 days after surgery
Secondary outcomes (8)
Rate of postoperative complications
Rate difference of overall postoperative complications- classified according to the Clavien-Dindo scale [ranging from 0 (no complications) to 5 (complications leading to death)]- in the study cohorts.
Measured: 90 days after surgery
Postoperative Recovery Profile (PRP) score
Median difference of Postoperative Recovery Profile (PRP) [ranging from 0 (completely recovered) to 68 (not recovered)] in the study cohorts.
Measured: 90 days after surgery
Proportion of 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) in the study cohorts.
Measured: 12 months after surgery
Low Anterior Resection Syndrome (LARS) score
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
Measured: 6 months after surgery or stoma closure
Low Anterior Resection Syndrome (LARS) score
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
Measured: 12 months after surgery or stoma closure
Low Anterior Resection Syndrome (LARS) score
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
Measured: 24 months after surgery or stoma closure
Cancer recurrence
Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start26 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- 472 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, IRCCS Huamanitas Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314646
- Sponsor's protocol ID
- 3747
- Acronym
- TTSS-REC
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2024
- Last updated
- 27 Jun 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative and Long-term Outcomes of Transanal Tran-section and Single-stapled Anastomosis (TTSS) in Rectal Can-cer Patients: a Multicentric International IDEAL Stage 2b Prospective Parallel Cohort Study
- ClinicalTrials.gov ID
- NCT06314646
- Acronym / sponsor ID
- TTSS-REC / 3747
- Conditions
- Rectal Cancer, Surgery
- Keywords
- Rectal Cancer, Transanal Transection and Single-Stapled anastomosis, Total Mesorectal Excision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 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.
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.
Detailed description
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique has become a valid alternative to the standard double-stapled anastomosis approach in the surgical treatment of low rectal cancer. Recent evidence showed a significantly reduced number of anastomotic leaks in patients undergoing TTSS compared with patients receiving double-stapled anastomosis, suggesting that TTSS may be technically feasible and may provide a surgical advantage over the traditional double-stapled technique. However, these studies were severely limited by their single-center and retrospective nature. This study aims to confirm the retrospective findings by extending the data collection to additional countries and provide prospective data collection.
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 rectal cancer surgery through low rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS) |
| Double-stapled Total Mesorectal Excision (TME) | – | Procedure: Double-stapled Total Mesorectal Excision (TME)Patients will undergo rectal cancer surgery through low rectal resection with double-stapled anastomosis Total Mesorectal Excision (TME) |
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 rectal cancer scheduled for elective rectal resection with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS).
Key inclusion criteria (3 listed)
- Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches.
- Patients scheduled for open, laparoscopic, or robotic surgery.
- Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma.
Key exclusion criteria (3 listed)
- Immediate or delayed hand-sewn coloanal anastomosis.
- Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
- Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors 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)Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS) | Procedure or surgery | Transanal Transection and Single-Stapled anastomosis (TTSS) |
| Double-stapled Total Mesorectal Excision (TME)Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME) | Procedure or surgery | Double-stapled Total Mesorectal Excision (TME) |
Primary outcome
Rate of anastomotic leak
Time frame: 90 days after surgery
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
8 secondary outcomes
Rate of postoperative complications
Time frame: 90 days after surgery
Postoperative Recovery Profile (PRP) score
Time frame: 90 days after surgery
Proportion of patients fit for stoma closure
Time frame: 12 months after surgery
Healthcare costs
Time frame: 12 months after surgery
Low Anterior Resection Syndrome (LARS) score
Time frame: 6 months after surgery or stoma closure
Low Anterior Resection Syndrome (LARS) score
Time frame: 12 months after surgery or stoma closure
Low Anterior Resection Syndrome (LARS) score
Time frame: 24 months after surgery or stoma closure
Cancer recurrence
Time frame: 24 months after surgery
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 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
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.
Antonino Spinelli, MD, PhD principal investigator
IRCCS Huamanitas Research Hospital
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 Cancer and Surgery, 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Jun 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?
Rate of anastomotic leak (time frame: 90 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 27 Jun 2024.