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.
Study Type
OBSERVATIONAL
Enrollment
472
Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)
Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
RECRUITINGRate of anastomotic leak
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
Time frame: 90 days after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after surgery
Healthcare costs
Median difference of healthcare costs (direct and indirect) in the study cohorts.
Time frame: 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.
Time frame: 6 months after surgery or stoma closure
Low Anterior Resection Syndrome (LARS) score
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Median difference of Low Anterior Resection Syndrome (LARS) score \[ranging from 0 (no LARS symptoms) to 42 (severe LARS symptoms)\] in the study cohorts.
Time frame: 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.
Time frame: 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.
Time frame: 24 months after surgery