Evidence map›Paper›PMID 40789775›Full record

Trial reportSurgical endoscopy2025

Impact of neoadjuvant treatment on functional outcomes after transanal total mesorectal excision (taTME)-a case series.

Katherine F Donovan, Elisa Paoluzzi Tomada, Heather Carmichael, Alison Ricardo, Natalie Berger, Antoinette Bonaccorso, Karim Alavi, Karen Zaghiyan, Alessio Pigazzi, Dana Sands and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03144765 (Multicenter Phase II Study of Transanal Total Mesorectal Excision), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03144765 naactive not recruitingnot on this map

Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer

TypeinterventionalSponsorIcahn School of Medicine at Mount SinaiRan2017 to 2027Enrolled100ConditionsRectal Cancer, SurgeryArmsTransanal Total Mesorectal Excision (taTME)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Katherine F DonovanDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.ORCID http://orcid.org/0009-0003-6657-500X
Elisa Paoluzzi TomadaDepartment of Biomedical Sciences, Humanitas University - Humanitas Research Hospital, Milan, Italy.
Heather CarmichaelDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.
Alison RicardoDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.
Natalie BergerDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.
Antoinette BonaccorsoDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA.
Karim AlaviDivision of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA, USA.
Karen ZaghiyanDivision of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Alessio PigazziDivision of Colorectal Surgery, Department of Surgery, New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.
Dana SandsDepartment of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, USA.
Theresa DeBeche-AdamsDepartment of Colon and Rectal Surgery, AdventHealth Orlando, Orlando, FL, USA.
Sami A ChadiDivision of Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre and University Health Network, Toronto, ON, Canada.
Elisabeth C McLemoreDivision of Colorectal Surgery, Department of Surgery, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
John H MarksDepartment of Colorectal Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
Justin A MaykelDivision of Colon and Rectal Surgery, UMass Memorial Medical Center, Worcester, MA, USA.
Sherief F ShawkiDepartment of Colorectal Surgery, Mayo Clinic, Rochester, MN, USA.
Scott R SteeleDepartment of Surgery, Cleveland Clinic, Cleveland, OH, USA.
Matthew AlbertDepartment of Colon and Rectal Surgery, AdventHealth Orlando, Orlando, FL, USA.
Mark H WhitefordGastrointestinal and Minimally Invasive Surgical Division, The Oregon Clinic, Providence Cancer Center, Portland, OR, USA.
Steven D WexnerDepartment of Colon and Rectal Surgery, Cleveland Clinic Florida, Weston, FL, USA.
Patricia SyllaDivision of Colon and Rectal Surgery, Mount Sinai Hospital, 5 East 98th Street, Box 1259, New York, NY, 10029, USA. patricia.sylla@mountsinai.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTotal mesorectal excision (TME) is known to adversely impact functional outcomes. In a recent Phase II multicenter prospective trial, significant decline in defecatory and sexual function and fecal incontinence-related quality of life (FIQL) was documented following transanal TME (taTME) for rectal cancer, with neoadjuvant treatment (NAT) identified as a predictor of worse function. However, the impact of NAT on baseline function is poorly understood.

methodsPatients in a Phase II multicenter trial (NCT03144765) who underwent taTME with or without NAT completed validated functional questionnaires assessing fecal incontinence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (male: IIEF, female: FSFI). Data were collected pre-NAT, post-NAT, 3-4 months after ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). Paired t-tests or Wilcoxon tests compared scores between timepoints.

resultsOf 71 patients who received NAT, 10 completed both pre- and post-NAT surveys. Median age was 58 years [IQR 48-61], and 7 patients were male. Tumors were located a median 4.75 cm [IQR 4.0-6.0 cm] from the anal verge. Median baseline COREFO score was 38.1 [29.2-49.8], indicating baseline defecatory dysfunction. No significant differences were observed between pre- and post-NAT scores, though FIQL scores demonstrated a trend toward worse incontinence-related quality of life post-NAT (p = 0.06). Postoperatively, Wexner, FIQL, and COREFO worsened from baseline and post-NAT levels, with partial improvement at 18 months post-op, without returning to baseline. No differences were observed in IPSS scores. IIEF scores showed no new erectile dysfunction post-NAT, but low sample size precluded FSFI analysis.

conclusionDefecatory, urinary, and sexual function were not significantly altered by NAT, though FIQL trends suggest worsening incontinence-related quality of life. Assessment of function and health-related quality of life at baseline and after each phase of therapy may help better inform patients about the impact of multimodal rectal cancer treatment.

Indexed as

Fecal IncontinenceNeoadjuvant TherapyPostoperative ComplicationsProctectomyRectal NeoplasmsTransanal Endoscopic SurgeryAgedDefecationFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeSexual Dysfunction, PhysiologicalTreatment OutcomeFunctional outcomesMinimally invasive surgeryNeoadjuvant therapyTaTME

Identifiers

PMID40789775

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.