Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results

Patricia Sylla; Dana Sands; Alison Ricardo; Antoinette Bonaccorso; Alexandros Polydorides; Mariana Berho; John Marks; Justin Maykel; Karim Alavi; Karen Zaghiyan; Mark Whiteford; Elisabeth Mclemore; Sami Chadi; Sherief F Shawki; Scott Steele; Alessio Pigazzi; Matthew Albert; Teresa DeBeche-Adams; Erin Moshier; Steven D Wexner

doi:10.1007/s00464-023-10266-9

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results

Surg Endosc. 2023 Dec;37(12):9483-9508. doi: 10.1007/s00464-023-10266-9. Epub 2023 Sep 12.

Authors

Patricia Sylla^{1

1}, Dana Sands², Alison Ricardo³, Antoinette Bonaccorso³, Alexandros Polydorides⁴, Mariana Berho⁵, John Marks⁶, Justin Maykel⁷, Karim Alavi⁷, Karen Zaghiyan⁸, Mark Whiteford⁹, Elisabeth Mclemore¹⁰, Sami Chadi¹¹, Sherief F Shawki¹², Scott Steele¹³, Alessio Pigazzi¹⁴, Matthew Albert¹⁵, Teresa DeBeche-Adams¹⁵, Erin Moshier¹⁶, Steven D Wexner¹⁷

Affiliations

¹ Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY, USA. patricia.sylla@mountsinai.org.
² Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, USA.
³ Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY, USA.
⁴ Department of Pathology, Mount Sinai Hospital, New York, NY, USA.
⁵ Executive Administration Florida, Cleveland Clinic Florida, Weston, FL, USA.
⁶ Department of Colorectal Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
⁷ Division of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA, USA.
⁸ Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁹ Gastrointestinal and Minimally Invasive Surgical Division, The Oregon Clinic, Providence Cancer Center, Portland, OR, USA.
¹⁰ Division of Colorectal Surgery, Department of Surgery, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
¹¹ Division of Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre and University Health Network, Toronto, ON, Canada.
¹² Department of Colorectal Surgery, Mayo Clinic, Rochester, MN, USA.
¹³ Department of Surgery, Cleveland Clinic, Cleveland, OH, USA.
¹⁴ Division of Colorectal Surgery, Department of Surgery, New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.
¹⁵ Department of Colon and Rectal Surgery, Advent Health Orlando, Orlando, FL, USA.
¹⁶ Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.
¹⁷ Department of Colorectal Surgery, Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA.

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.

Keywords: Anastomotic complication; Circumferential radial margin; Conversion; Rectal cancer; Stoma-free rate; TME grade; Transanal total mesorectal excision.

Publication types

Clinical Trial, Phase II
Multicenter Study

MeSH terms

Female
Humans
Laparoscopy* / methods
Male
Middle Aged
Postoperative Complications / epidemiology
Postoperative Complications / etiology
Postoperative Complications / pathology
Proctectomy* / methods
Prospective Studies
Rectal Neoplasms* / pathology
Rectum / pathology
Rectum / surgery
Transanal Endoscopic Surgery* / methods
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03144765