학술논문
Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.
Document Type
Article
Author
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; Wexner, Steven D.
Source
Subject
Language
ISSN
1866-6817
Abstract
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/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5–7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien–Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1–7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). 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. [ABSTRACT FROM AUTHOR]