- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06314646
Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients (TTSS-REC)
March 18, 2024 updated by: Istituto Clinico Humanitas
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
472
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annalisa Maroli, PhD
- Phone Number: 0039 02 8224 7776
- Email: colorapp@humanitas.it
Study Contact Backup
- Name: Stefano De Zanet, MS
- Phone Number: 0039 02 8224 4623
- Email: colorapp@humanitas.it
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
Low anterior rectal resection with 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)
|
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of anastomotic leak
Time Frame: 90 days after surgery
|
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
|
90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of postoperative complications
Time Frame: 90 days after surgery
|
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.
|
90 days after surgery
|
Postoperative Recovery Profile (PRP) score
Time Frame: 90 days after surgery
|
Median difference of Postoperative Recovery Profile (PRP) [ranging from 0 (completely recovered) to 68 (not recovered)] in the study cohorts.
|
90 days after surgery
|
Proportion of patients fit for stoma closure
Time Frame: 12 months after surgery
|
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.
|
12 months after surgery
|
Healthcare costs
Time Frame: 12 months after surgery
|
Median difference of healthcare costs (direct and indirect) in the study cohorts.
|
12 months after surgery
|
Cancer recurrence
Time Frame: 24 months after surgery
|
Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts.
|
24 months after surgery
|
Low Anterior Resection Syndrome (LARS) score
Time Frame: 6 months after surgery or stoma closure
|
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
|
6 months after surgery or stoma closure
|
Low Anterior Resection Syndrome (LARS) score
Time Frame: 12 months after surgery or stoma closure
|
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
|
12 months after surgery or stoma closure
|
Low Anterior Resection Syndrome (LARS) score
Time Frame: 24 months after surgery or stoma closure
|
Median difference of Low Anterior Resection Syndrome (LARS) score [ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)] in the study cohorts.
|
24 months after surgery or stoma closure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Huamanitas Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 31, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 11, 2024
First Submitted That Met QC Criteria
March 11, 2024
First Posted (Actual)
March 18, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
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Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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