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Functional Outcomes after Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results from the North American Multicenter taTME Trial
*Katherine F. Donovan1, *Katherine C. Lee1, *Alison Ricardo1, *Antoinette Bonaccorso1, *Natalie F. Berger1, *Dana Sands2, *John Marks3, *Justin Maykel4, *Karim Alavi4, *Karen Zaghiyan5, *Mark Whiteford6, *Elisabeth Mclemore7, *Sami Chadi8, *Sherief F. Shawki9, *Scott Steele10, *Alessio Pigazzi11, *Matthew Albert12, *Theresa DeBeche-Adams12, *Fu-Yuan Cheng13, Steven Wexner14, Patricia Sylla1
1Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York, NY; 2Department of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL; 3Department of Colorectal Surgery, Lankenau Medical Center, Wynnewood, PA; 4Division of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA; 5Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA; 6Gastrointestinal and Minimally Invasive Surgical Division, The Oregon Clinic, Providence Cancer Center, Portland, OR; 7Division of Colorectal Surgery, Department of Surgery, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 8Division of Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre and University Health Network, Toronto, ON, Canada; 9Department of Colorectal Surgery, Mayo Clinic, Rochester, MN; 10Department of Surgery, Cleveland Clinic, Cleveland, OH; 11Division of Colorectal Surgery, New York-Presbyterian Weill Cornell Medical Center, New York, NY; 12Department of Colon and Rectal Surgery, Advent Health Orlando, Orlando, FL; 13Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, NY; 14Department of Colorectal Surgery, Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL

Objective: Proctectomy for rectal cancer may result in substantial alterations in defecatory, urinary, and sexual function that can persist beyond 12 months postoperatively. The recent multicenter Phase II taTME trial demonstrated the procedural and preliminary oncologic safety of sphincter-preserving taTME in patients with stage I-III rectal tumors. We now report the short and long-term postoperative functional outcomes relative to preoperative baseline in this cohort. Methods: This analysis consisted of prospectively registered self-reported questionnaire data collected from patients enrolled in the Phase II taTME trial. Fecal continence (FIQL and Wexner), defecatory function (COREFO), urinary function (IPSS), and female/male sexual function (FSFI, IIEF) scores were assessed preoperatively (PQ), 3-4 months post-ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). Scores at all 3 time points were compared using Wilcoxon Signed-Rank test. Results: TaTME was performed in 70 males and 30 females with median age 58 (IQR 49-62) and median BMI 27.8 (IQR 23.9–31.8) kg/m2. 71 patients received neoadjuvant treatment. Tumors were located a median of 5.8 (IQR 4.5-7.0) cm from the anal verge with intersphincteric resection performed in 36% and handsewn anastomoses in 54%. Ileostomy was created in all 100 patients and reversed in 98 after a median of 5.8 (IQR 3.1-7.4) months. The PQ, FQ1, and FQ2 completion rate was 99%, 94%, and 91%. Median time from taTME to FQ1 was 9.5 (IQR 7.2–11.0) months and to FQ2 was 18.7 months (IQR 16.0–20.1). Among 85 patients who completed questionnaires at all time points, FIQL, Wexner, and COREFO in all domains significantly worsened between PQ and FQ1 (Fig 1A-B, 1D, p<0.01). Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved (p<0.05). FIQL depression and embarrassment did not change between FQ1 and FQ2 (p=0.18 and p=0.30, respectively). There was no change in urinary function (IPSS) at any time (Fig 1C). For females, FSFI significantly declined for desire, arousal, lubrication, orgasm, and satisfaction between PQ and FQ1 (Fig 1E, p<0.05), but did not change between FQ1 and FQ2. In males, IIEF score significantly declined across all domains post-operatively (Fig 1F, p<0.05) with no change between FQ1 and FQ2. Conclusions: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains significantly improved by 12 months without returning to baseline. Urinary function was preserved while sexual function significantly declined in both males and females without significant improvement by 18 months. Our results address patient expectations and inform shared decision-making regarding sphincter-preserving taTME. The prevalence of depression and embarrassment related to fecal continence that persist beyond 12 months provides opportunities for intervention and peer support.

Figure 1. Questionnaire scores pre-surgery (PQ), 3-4 months post-ileostomy-closure (FQ1), 12-18 months post-taTME (FQ2). * signifies statistical significance (p<0.05). A. Fecal Incontinence Quality of Life (FIQL). B. Wexner. C. International Prostate Symptom Score (IPSS). D. COREFO. E. Female Sexual Function Index (FSFI) (n=25). F. International Index of Erectile Function (IIEF) (n=58).
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