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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) | Patients will undergo rectal cancer surgery through low rectal resection with double-stapled anastomosis Total Mesorectal Excision (TME) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | Procedure | Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of anastomotic leak | Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts. | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after surgery |
| Postoperative Recovery Profile (PRP) score |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Stefano De Zanet, MS | Contact | 02 8224 4623 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | IRCCS Huamanitas Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Double-stapled Total Mesorectal Excision (TME) | Procedure | Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME) |
|
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 | 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 | Median difference of healthcare costs (direct and indirect) in the study cohorts. | 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. | 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. | 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. | 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. | 24 months after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |