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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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>100 patients with stage I\u2013III rectal adenocarcinoma located\u2009\u2264\u200910\u00a0cm 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49\u201362) years and BMI 27.8 (IQR 23.9\u201331.8) kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5\u20137.0) 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\u2013Dindo (CD)\u2009\u2265\u20093 in 28.6%) and 56% (CD\u2009\u2265\u20093 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30\u00a0days. Higher anastomotic risk was noted among males (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.05). At a median follow-up of 5 (IQR 3.1\u20137.4) 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\u2009\u2265\u20093 (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.01), increased time between NRT and surgery (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.03), and higher operative blood loss (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.003).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s00464-023-10266-9","type":"journal-article","created":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T16:32:01Z","timestamp":1694536321000},"page":"9483-9508","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results"],"prefix":"10.1007","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9737-994X","authenticated-orcid":false,"given":"Patricia","family":"Sylla","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Sands","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Ricardo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoinette","family":"Bonaccorso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandros","family":"Polydorides","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana","family":"Berho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Marks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Maykel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karim","family":"Alavi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Zaghiyan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Whiteford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Mclemore","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sami","family":"Chadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherief F.","family":"Shawki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Steele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Pigazzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Albert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"DeBeche-Adams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Moshier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven D.","family":"Wexner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,9,12]]},"reference":[{"key":"10266_CR1","doi-asserted-by":"publisher","first-page":"589","DOI":"10.1097\/SLA.0000000000003002","volume":"269","author":"J Fleshman","year":"2019","unstructured":"Fleshman J, Branda ME, Sargent DJ, Boller AM, George VV, Abbas MA, Peters WR Jr, Maun DC, Chang GJ, Herline A, Fichera A, Mutch MG, Wexner SD, Whiteford MH, Marks J, Birnbaum E, Margolin DA, Larson DW, Marcello PW, Posner MC, Read TE, Monson JRT, Wren SM, Pisters PWT, Nelson H (2019) Disease-free survival and local recurrence for laparoscopic resection compared with open resection of stage II to III rectal cancer: follow-up results of the ACOSOG Z6051 randomized controlled trial. 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Dr. Alexandros Polydorides reports royalties or licenses with Elsevier, Med Learning Group, payment or honoraria from Johns Hopkins and USCAP, and payment for various expert testimony. Dr. John Marks serves as a consultant for Stryker and Intuitive, reports payment or honoraria from Stryker and Medtronic, and participates on the data safety monitoring board (DSMB) or advisory board for Virtual Incision. Dr. Elisabeth McLemore serves as a chair on the SAGES Colorectal Surgery Committee. Dr. Justin Maykel reports consultant fees for Olympus, Takeda, Safeheal, RedDress, and Applied Medical, and payment for expert testimony for medical legal review. Dr. Karim Alavi reports consultant fees for Safeheal and Olympus, payment for expert testimony for Crico, and serves on the DCR editorial board and as an Operative Competency Committee Chair of ASCRS. Dr. Karen Zaghiyan reports grants received by Surgical Research Network and Crohn\u2019s & Colitis Foundation, consultant fees for Takeda and Intuitive, and payment or honoraria from Natera. Dr. Sami Chadi serves as a consultant for Stryker and Noah Medical and receives payment or honoraria from Stryker. Dr. Alessio Pigazzi reports receiving a Research grant from Vioptix, royalties with Xodus Medical, and serves as a consultant for Medtronic, Ethicon, and Intuitive. Dr. Matt Albert reports grants or contracts from Applied Medical, Stryker Endoscopy, Conmed, Human Extensions, Endoquest, Livsmed, Astellas Pharmaceuticals, Distal Motion, Proximie, and Noah, serves as a consultant and receives payment or honoraria from Applied Medical, Stryker, Distal Motion, EndoQuest, Astellas Pharmaceuticals, Livsmed, and ConMed, participates on the DSMB or Advisory board for Proximie and Distal Motion, and holds stock or stock options for Applied Medical, Proximie, and Human Extension. Dr. Teresa deBeche-Adams receives personal honoraria for educational courses with support for travel expenses from Applied Medical. Erin Moshier reports a grant received for biostatistical support by the National Cancer Institute Cancer Center Support Grant P30CA196521-01, which was awarded to the Tisch Cancer Institute of the Icahn School of Medicine at Mount Sinai. Dr. Steven Wexner receives consulting fees from ARC\/Corvus, Baxter, Becton Dickinson, GI Supply, ICON Clinical Research Limited, Intuitive Surgical, Leading BioSciences, Leading Biosciences\/Pallisade Bio, Livsmed, Medtronic, Olympus, Stryker, and Takeda and receives royalties from Intuitive Surgical, Karl Storz Endoscopy America Inc, Medtronic, and Unique Surgical Innovations LLC. Dr. Dana Sands, Dr. Alison Ricardo, Dr. Antoinette Bonaccorso, Dr. Mariana Berho, Dr. Mark Whiteford, Dr. Sherief Shawki, and Dr. Scott Steele have no financial disclosures to report.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclosures"}}]}}