Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.
oregon; portland; Anastomotic complication; Circumferential radial margin; Conversion; Rectal cancer; Stoma-free rate; TME grade; Transanal total mesorectal excision
BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765).
METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications.
RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m
CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.
Sylla, Patricia; Sands, Dana; Ricardo, Alison; Bonaccorso, Antoinette; Polydorides, Alexandros; Berho, Mariana; Marks, John; Maykel, Justin; Alavi, Karim; Zaghiyan, Karen; Whiteford, Mark; Mclemore, Elisabeth; Chadi, Sami; Shawki, Sherief F; Steele, Scott; Pigazzi, Alessio; Albert, Matthew; DeBeche-Adams, Teresa; Moshier, Erin; and Wexner, Steven D, "Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results." (2023). Articles, Abstracts, and Reports. 7870.