Rectal Cancer, Surgery
Conditions
Keywords
Rectal Cancer, Transanal Transection and Single-Stapled anastomosis, Total Mesorectal Excision
Brief 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.
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.
Interventions
Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
PROCEDUREDouble-stapled Total Mesorectal Excision (TME)
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.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 Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anastomotic leak | 90 days after surgery | Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Recovery Profile (PRP) score | 90 days after surgery | Median difference of Postoperative Recovery Profile (PRP) \[ranging from 0 (completely recovered) to 68 (not recovered)\] in the study cohorts. |
| Proportion of patients fit for stoma closure | 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. |
| Rate of postoperative complications | 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. |
| Low Anterior Resection Syndrome (LARS) score | 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. |
| Cancer recurrence | 24 months after surgery | Incidence rate difference of cancer recurrence- defined as any local or distal recurrence or metastasis- in the study cohorts. |
| Healthcare costs | 12 months after surgery | Median difference of healthcare costs (direct and indirect) in the study cohorts. |
Countries
Italy
Contacts
Primary ContactAnnalisa Maroli, PhD
Backup ContactStefano De Zanet, MS
Outcome results
None listed