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The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below.

The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.

TaTME

Conventional Laparoscopic Total Mesorectal Excision

LpTME

Liang Kang, MD,PHD

Yi Xiao, MD, PhD

Weidong Tong, MD, PhD

Liang Kang, MD, PhD

Yanan Wang, MD.PhD

Qingwen Xu, MD

Ming Xie, MD

Yi Zhang, MD,PhD

Jun Ouyang, MD

Quan Wang, MD,PhD

Hong Zhang, MD

Yongchun Song, MD

Bo Feng, MD,PhD

Qing Xu, MD, PhD

Mingyang Ren, MD

Miao Wu, MD

Dan Ma, MD,Phd

Jianping Wang, MD,PHD

Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called "down-to-up" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.

Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising surgical alternative for rectal cancer, especially for mid and low rectal cancer. Theoretically, TaTME holds the potential advantage of providing better access to mobilize the distal rectum, and thus could achieve better pathologic outcomes, such as lower involved circumferential margin (CRM) and incomplete resected mesorectum, which could translate into better oncological outcome for the patients in the long term. However, until now, the feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision, LpTME) of this technique has only been validated in studies with limitations of small sample size, retrospective nature.

Study Objective:This study aims to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival results.

Study design This study is a prospective, multi-center, randomized, open-label, parallel group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic data capture (EDC) system will be utilized for randomization, electronic CRF and data collection. All comparative analyses will be conducted on an "intention to treat" basis.

Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the sample size according to 5-year OS was larger than that based on 3-year DFS. The expected 5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%. Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a total of 1114 patients were planned to enroll for this trial.

Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS) rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection quality, mainly including circumferential involvement rate, and completeness of mesorectum. Resected specimen was pathologically processed and assessed at each center by trained and qualified pathologists independently.2)short term operative results such as morbidity and mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall survival. Besides, functional outcome and quality of life are also evaluated.

Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer

Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial

The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)

To evaluate defecating function with Wexner score

To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire

To evaluate quality of life with EORTC QLQ-30 questionnaire

Peking Union Medical College Hospital

The First Hospital of Jilin University

RenJi Hospital

Shengjing Hospital

The Second People's Hospital of Yibin

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Nanchong Central Hospital

Zunyi Medical College

The First Affiliated Hospital of University of South China

Xinqiao Hospital

Nanfang Hospital, Southern Medical University

First Affiliated Hospital Xi'an Jiaotong University

Ruijin Hospital

Affiliated Hospital of Guangdong Medical University

The Third Xiangya Hospital of Central South University

Sun Yat-sen University

Symptoms and General Pathology

Recurrence

Disease Attributes

patients with rectal cancer receiving transanal TME

patients with rectal cancer receiving open, laparoscopic or robotic TME

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.

taTME

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.

abdTME

Lukas Marti, Dr. med.

Yanic Ammann

Lukas Marti, M D

Kathrin Müller

This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.

Rectal cancer accounts for 3.8% of all new cancer diagnosis and for 3.4% of all cancer-related deaths in the world in 2020. Regarding treatment of rectal cancer, it is essential to perform surgery along the anatomical and embryological planes. This technique called total mesorectal excision (TME) reduces the local recurrence rate and improves the survival. Since the early 2000, TME has changed from open to laparoscopic approach due to better results in short-term outcome. Nevertheless, oncological benefits are modest. In 2009 the first ever transanal TME (taTME) war performed. This novel technique combines abdominal with transanal dissection. Because the distal part of the rectum is approached from below, a better visualization of the mesorectal plane resulting in higher rate of free CRM and of complete TME specimen grade (Quirke Score) can be accomplished. However, taTME remains a hot topic in the current scientific literature. In Norway and the Netherlands a higher rate of anastomotic leakage as well as a higher rate of local recurrence (9.5%) with multifocal growth pattern were described.

Abdominal or Transanal TME for Rectal Cancer Therapy

Abdominal or Transanal TME in Therapy of Rectal Cancer: A Retrospective Cohort Study

time from surgery to end of follow-up or death

time from surgery to end of follow-up or death due to rectal cancer

time from surgery to end of follow-up or death due to or recurrence of rectal cancer

tumor extending to the resection margin in pathological examination (R0, R1)

Quality of mesorectal excision in pathological examination (Good, modest, bad)

size of circular resection margin (mm) in pathological examination

number of lymph nodes in pathological examination

Number of patients with postoperative complications (bleeding, anastomotic leakage, ileus, sacral infect, fistula, other surgical complications). The complications will be classified according the Clavien-Dindo-Classification

Number of patients who die in the first 90 days after surgery

Cantonal Hospital of St. Gallen

Dr. med. Lukas Marti, Leitender Arzt Chirurgie

Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME).

Study procedures consist in 1-team (sequential) or 2-team (combined) low anterior resection with transanal TME using laparoscopic or robotic abdominal assistance.

Transanal Total Mesorectal Excision (taTME)

Patricia Sylla, MD

Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach.

Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer.

Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

The management of rectal cancer is multidisciplinary and outcomes are dependent on accurate preoperative staging, performance of a curative resection, and the selective use of neoadjuvant and adjuvant therapy to improve long-term oncologic outcomes. Despite the increasing use of laparoscopic and robotic approaches, radical rectal cancer resection is associated with relatively high rates of conversion to open surgery, variable rates of TME specimen completeness, and morbidity rates that are equivalent to that of open TME with respect to infectious and wound-related complications, as well as defecatory, sexual and urinary dysfunction,.

Transanal TME (taTME) with laparoscopic assistance was developed in an effort to facilitate completion of TME using a primarily transanal endoscopic approach. Based on the preliminary results from several published single-center case series and the first international taTME registry, in carefully selected patients with resectable rectal cancer, taTME with laparoscopic assistance is associated with perioperative outcomes and short-term oncologic outcomes that are equivalent to that of standard TME.

This study is the first phase II multicenter trial of taTME conducted in the United States to evaluate the efficacy and safety of taTME with laparoscopic or robotic assistance relative to standard LAR. A total of 100 subjects with resectable rectal cancer located up to 10 cm from the anal verge will be enrolled across 10 US study sites. It is anticipated that this larger, phase II multicenter study will validate the safety and efficacy of taTME with respect to perioperative outcomes, short and long-term oncologic outcomes and functional results.

Study procedure:

Study procedures will consist in 1-team (sequential) or 2-team (combined) LAR with transanal TME using laparoscopic or robotic abdominal assistance. Laparoscopic or robotic abdominal access will be obtained followed by inferior mesenteric vessels transection, mobilization or the proximal colon and splenic flexure takedown if indicated. Transanal TME is performed either at the same time or following the above steps. Intersphincteric resection (ISR) may be included for very low tumors. Following pursestring closure of the rectum below the tumor, transanal endoscopic TME dissection will proceed circumferentially until the peritoneal cavity is entered anteriorly. Following complete mobilization of the rectosigmoid, the specimen is extracted transanally or transabdominally followed by colorectal or coloanal anastomosis, with or without a diverting loop ileostomy. Operative details will be recorded in case report forms (CRF's).

TME pathology assessment:

Resected specimens will be processed and analyzed by the participating institution's Pathology Department according to standard TME protocol. De-identified photographs of all fresh TME specimens will be independently reviewed by a Pathology Review Committee blinded to the source of the specimen.

Postoperative care and follow-up:

Subjects will be managed according to standard postoperative protocols. Postoperative visits and oncology follow-up visits will occur as per standard practice and oncologic outcomes. All adverse events occurring during the study period will be graded using the Clavien-Dindo system. Postoperative functional questionnaires will be obtained 6-8 months and 12-14 months postoperatively in non-diverted subjects. In diverted subjects, functional questionnaires will be collected 3-4 months and 9-10 months following ileostomy closure (or 12-18 months following the study procedure).

Multicenter Phase II Study of Transanal TME (taTME)

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

Rate of complete and near-complete mesorectal excision achieved with taTME, based on standard pathologic assessment of TME specimens.

The rate of complications experienced intraoperatively and postoperatively (within 30 days of the study procedure)

Incidence of long-term term postoperative complications

Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores from baseline up to 18 months postoperatively - 27 items. All questions can be answered by choosing from five response options; No; Never; Yes, less than once a week; Yes, 1-2 days per week; Yes, 3-5 days per week; Yes, 6-7 days per week.

Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered.

Alterations in Wexner score from baseline up to 18 months postoperatively. Wexner questionnaire - 5 questions and scored from 0 = never to 4= always, with total score from 0 (no incontinence) to 20 (complete incontinence)

Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)

Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.

Alterations in International Prostate Symptom Score (IPSS) from baseline up to 18 months postoperatively - IPSS 8 questions total - 7 questions related to symptoms, each item scored 1-5. (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Total scale ranges from 8-35. Mild (symptom score less than of equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35).

3-year local recurrence rate, distant recurrence rate, disease-free survival and overall survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer	NCT02966483	Rectal Neoplasm... Surgery	TaTME LpTME	18 Years - 75 Years	Sun Yat-sen University
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer	NCT02966483	Rectal Neoplasm... Surgery	TaTME LpTME	18 Years - 75 Years	Sun Yat-sen University
Abdominal or Transanal TME for Rectal Cancer Therapy	NCT04969107	Survival Postoperative M... Mortality Recurrence	taTME abdTME	18 Years -	Cantonal Hospital of St. Gallen
Multicenter Phase II Study of Transanal TME (taTME)	NCT03144765	Rectal Cancer Surgery	Transanal Total...	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for transanal

Every month we try and update this database with for transanal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for transanal

Every month we try and update this database with for transanal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for transanal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.