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

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, and Wexner, Steven D.

Published
2023
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6. Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

Author

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

Published
2023
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8. Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results From the Phase II North American Multicenter Prospective Observational Trial.

Author

Donovan, Katherine F., Lee, Katherine C., Ricardo, Alison, Berger, Natalie, Bonaccorso, Antoinette, Alavi, Karim, Zaghiyan, Karen, Pigazzi, Alessio, Sands, Dana, DeBeche-Adams, Teresa, Chadi, Sami A., McLemore, Elisabeth C., Marks, John H., Maykel, Justin A., Shawki, Sherief F., Steele, Scott R., Albert, Matthew, Whiteford, Mark H., Fu-Yuan Cheng, and Wexner, Steven D.

Abstract

Objective: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after transanal total mesorectal excision (taTME). Background: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter phase II taTME trial demonstrated the safety of taTME in patients with stage I to III tumors. Methods: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence [Fecal Incontinence Quality of Life (FIQL), Wexner], defecatory function [Colorectal Functional Outcome (COREFO)], urinary function (International Prostate Symptom Score), and sexual function (Female Sexual Function Index-female, International Index of Erectile Function-male) were assessed preoperatively (PQ), 3 to 4 months postileostomy closure (FQ1), and 12 to 18 months posttaTME [postoperative questionnaire 2 (FQ2)]. Results: Among 83 patients who responded at all 3 time points, FIQL, Wexner, and COREFO significantly worsened postileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. International Prostate Symptom Score did not change relative to preoperative scores. For females, Female Sexual Function Index declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, International Index of Erectile Function declined with no change between FQ1 and FQ2. Conclusions: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decisionmaking regarding taTME. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Complications

Author

Maykel, Justin A., Schlussel, Andrew T., Stein, Sharon L., editor, and Lawson, Regan R., editor

Published
2020
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12. SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE‐2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

Author

Hain, Elisabeth, Lefèvre, Jérémie H., Ricardo, Alison, Lee, Sang, Zaghiyan, Karen, McLemore, Elisabeth, Sherwinter, Danny, Rhee, Rebecca, Wilson, Matthew, Martz, Joseph, Maykel, Justin, Marks, John, Marcet, Jorge, Rouanet, Philippe, Maggiori, Leon, Komen, Niels, De Hous, Nicolas, Lakkis, Zaher, Tuech, Jean‐Jacques, and Attiyeh, Fadi

Subjects
ILEOSTOMY, CLINICAL trials, SURGICAL anastomosis, SURGICAL complications, RECTAL cancer, ONCOLOGIC surgery
Abstract

Aim: Although proximal faecal diversion is standard of care to protect patients with high‐risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE‐1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE‐2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. Methods: SAFE‐2 is a pivotal, multicentre, prospective, open‐label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co‐primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. Discussion: SAFE‐2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. Trial registration: NCT05010850. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Patient Evaluation

Author

Suwanabol, Pasithorn A., Maykel, Justin A., Beck, David E., editor, Steele, Scott R., editor, and Wexner, Steven D., editor

Published
2019
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35. Perioperative Considerations

Author

Damle, Aneel, Maykel, Justin A., Ross, Howard, editor, Lee, Sang, editor, Champagne, Bradley J., editor, Pigazzi, Alessio, editor, and Rivadeneira, David E., editor

Published
2015
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36. Laparoscopic Abdominoperineal Resection

Author

Davids, Jennifer S., Maykel, Justin A., Ross MD FACS FASCRS, Howard M., editor, Lee MD, FACS, FASCRS, Sang W., editor, Mutch MD, FACS, FASCRS, Matthew G., editor, Rivadeneira MD, MBA,FACS, FASCRS, David E., editor, and Steele M.D., FACS, FASCRS, Scott R., editor

Published
2015
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37. St.Gallen consensus on safe implementation of transanal total mesorectal excision

Author

Adamina, Michel, Buchs, Nicolas C., Penna, Marta, Hompes, Roel, Adamina, Michel, Aigner, Felix, Albert, Matthew, Bell, Stephen, Bemelman, Willem, Boni, Luigi, Brown, Carl J., Brown, Gina, Buchs, Nicolas C., Grieder, Felix, Güller, Ulrich, Hompes, Roel, d’Hoore, André, Huscher, Cristiano, Ito, Masaaki, Kneist, Werner, Knol, Joep, Lacy, Antonio, Maykel, Justin, Merrie, Arend, Oh, Jae Hwan, Panis, Yves, Penna, Marta, Perez, Rodrigo Oliva, Pfeffer, Frank, Quirke, Philip, Rouanet, Philippe, Rullier, Eric, Seitinger, Gerald, Sietses, Colin, Spinelli, Antonino, Stevenson, Andrew R. L., Sylla, Patricia, Tekkis, Paris, Tuech, Jean-Jacques, Tuynman, Jurriaan, Warusavitarne, Janindra, Whiteford, Mark, Winter, Des, Wolthuis, Albert, and on behalf of the St.Gallen Colorectal Consensus Expert Group

Published
2017
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39. Other Benign Colorectal Disorders

Author

Maykel, Justin A., Steele, Scott R., Beck, David E., editor, Wexner, Steven D., editor, Hull, Tracy L., editor, Roberts, Patricia L., editor, Saclarides, Theodore J., editor, Senagore, Anthony J., editor, Stamos, Michael J., editor, and Steele, Scott R., editor

Published
2014
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41. The evolution of evaluation and management of urinary or fecal incontinence and pelvic organ prolapse

Author

Steele, Scott R., Varma, Madhulika G., Prichard, David, Bharucha, Adil E., Vogler, Sarah A., Erdogan, Askin, Rao, Satish S.C., Lowry, Ann C., Lange, Erin O., Hall, Glen M., Bleier, Joshua I.S., Senagore, Anthony J., Maykel, Justin, Chan, Sook Y., Paquette, Ian M., Audett, Marie C., Bastawrous, Amir, Umamaheswaran, Preetha, Fleshman, James W., Caton, Gentry, O’Brien, Brendan S., Nelson, Jeffery M., Steiner, Ari, Garely, Alan, Noor, Nabila, Desrosiers, Laurephile, Kelley, Robert, and Jacobson, Nina S.

Published
2015
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47. Other Benign Colorectal Disorders

Author

Maykel, Justin A., Steele, Scott R., Beck, David E., editor, Roberts, Patricia L., editor, Saclarides, Theodore J., editor, Senagore, Anthony J., editor, Stamos, Michael J., editor, and Wexner, Steven D., editor

Published
2011
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