Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Syndrome

Low Anterior Resection Syndrome

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients undergoing open low anterior resection

Patients undergoing laparoscopic low anterior resection

Patients undergoing robotic low anterior resection

Patients undergoing transanal Total Mesorectal Excision (taTME)

Open approach for Total Mesorectal Excision

Open Total Mesorectal Excision

Laparoscopic approach for Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Robotic approach for Total Mesorectal Excision

Robotic Total Mesorectal Excision

Transanal approach for Total Mesorectal Excision

Transanal Total Mesorectal Excision

Patricia Tejedor

Carlos Pastor

The surgical management of rectal cancer includes a Total Mesorectal Excison (TME); depending on the height of the tumor, the problem of preservation of the anal sphincter arises, being able to perform a low anterior resection, an ultra-low anterior resection (RAUB) or an intersphincteric dissection. In some cases invading the sphincters or the puborectalis muscle, an abdominoperineal resection needs to be performed, being the gold standard in this particular situation so far.

TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer.

The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/without derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm), 10) rectal resection following a 'watch \& wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease.

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be 3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023).

It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.

Patient Reported Outcomes Following Cancer of the Rectum

LARS score from 0-42 where 0 means better outcomes

Incontinence score from 0-28 where 0 means better outcomes

Quality of life questionnaire, colorectal cancer related

University of Navarrra Hospital (Clinica Universitaria)

Hospital de Leon

Hospital del Río Hortega

University Hospital Gregorio Marañón

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Retention

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure

a transanal bottom-up approach was employed for the TME procedure

transanal total mesorectal excision

A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received

Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.

Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer

Urinary Retention Following Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Yanhong Deng

Director

Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually.

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.

The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.

robot-assisted total mesorectal excision

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

laparoscopic total mesorectal excision

This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.

Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.

Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer

A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function

DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause

Southwest Hospital, China

Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）

Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision.

Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）

Transanal total mesorectal excision

Patients undergo Laparoscopic total mesorectal excision.

Laparoscopic total mesorectal excision

Yimei Jiang, MD

This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.

Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer

Positive rate of circumferential resection margin (pathological assessment)

Pathological assessment of completeness of the TME specimen（complete, near

Length of distal margin （millimeter，mm）

Estimated blood loss（milliliters，ml）

Duration of hospital stay（days after surgery）

Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge

Ruijin Hospital

Chief Physicion

Cases which undergo rectal resection with laparoscopic intersphincteric resection.

Cases with rectal cancer which undergo Transanal minimally invasive Total mesorectal excision.

the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum

laparoscopic intersphincteric resection (LISR group)

Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.

Transanal minimally invasive Total mesorectal excision (TAMIS group)

Osama eldamshety, PhD

Sherif Kotb, PhD, MD

Adel Fathi, PhD, MD

A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.

Ideal surgery for rectal cancer should not only obtain adequate radial and circumferential margins, but also preserve normal sphincter function.In 1990, the results of a 'close shave' at anterior resection were reported, suggesting that a resection margin of 1 cm or less produced an oncological outcome similar to that of a resection margin greater than 1 cm.

Sphincter preservation presents several advantages; The lower risk of intraoperative rectal perforation and positive circumferential margin than APR, the lower risk of damaging the pelvic branches of the pelvic autonomic nerve and The preservation of the body image that may increase quality of life.

Recently, the clinical outcome of intersphincteric resection (ISR) as a laparoscopic approach (laparoscopic ISR) has been reported, but laparoscopic ISR for patients with bulky low rectal cancer remains challenging particularly for T3 tumors in patients with a narrow pelvis, because of the difficulty in understanding the accurate anatomy of the small pelvic cavity, in dissecting the TME or the tumor specific mesorectal excision (TSME) plane, and in transecting the lower rectum safely. Moreover, numerous studies have demonstrated that laparoscopic techniques have many advantages in colorectal surgery compared with open surgery.

Although Radical resection is the gold standard for the treatment of rectal cancer, TEM offers the advantage of combining a minimally invasive technique with evident benefits in terms of postoperative morbidity and recovery, long-term functional outcomes and subsequently improved quality of life. Transanal Endoscopic Microsurgery (TEM) developed at 1984 and eliminated most of local transanal excision limitations and triggered a significant improvement in the local excision procedures of rectal lesions. While TEM became the 'gold standard' for the treatment of large rectal adenomas and early rectal cancer, there are special concerns about the lack of adequate lymphadenectomy.

Preoperative chemoradiation therapy is widely used to treat locally advanced rectal cancer to increase resectability, and to enhance sphincter preservation, local control and possibly, survival rates. Surgery is performed six to eight weeks after radiotherapy.

Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).

Outcomes of Transanal Minimally Invasive TME Versus Laparoscopic Intersphincteric Resection Techniques for Rectal Cancer After Initial Neoadjuvant Chemo-radiotherapy: Double Blinded Study

Hospital stay starting from the day of admission till discharge.

Mansoura University

associate lecturer of surgical oncology

Transanally, the rectum is mobilized through the mesorectal plane according to the TME principles, assisted by the transanal surgical platform (Transanally curable surgical resection).

By standard laparoscopic techniques, the rectal cancer will be resected by the conventional laparoscopic TME (LaTME).

Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

Transanally curable surgical resection

Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

Minhua Zheng, M.D., PhD.

Jing Sun, M.D., PhD.

Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.

Background: Transanal total mesorectal excision (TaTME) is increasingly accepted as one of the alternative patterns for the resectable rectal cancer worldwide since its first appearance. For mid-low rectal cancer, TaTME features superior viewpoints and direct access to mobilize the primary lesion without the pelvic anatomic limits. Therefore, the matured TaTME technique could deliver satisfactory clinic outcomes in both surgical and oncological senses. However, the studies that designed to compare the feasibility and repeatability of TaTME with conventional laparoscopic total mesorectal excision (LaTME) remain sparse and limited.

Study Objective: Evaluation of short-term mortality and morbidity, long term overall survival and disease-free survival as well as quality of life in rectal cancer patients in East China.

Study Design: This study is a prospective, single-center, randomized clinical trial with a central monitored electronic data processing system. Corresponding randomization, data collection and comparative analysis will be conducted based on the research group discussion. According to the non-inferiority principle, the power is 80% and the α is 0.05 with 10% margin delta (δ). Total patients will be 258, with 129 in each group given 10% lost in follow-up.

Study Endpoints: The primary outcomes measures will be the Disease-free survival (3-years). The secondary outcomes measures will be overall survival (3-years), mesorectal completeness (the quality of the TME specimen, complete, near complete, incomplete), positive circumferential resection margin (CRM), number of retrieved lymph nodes, morbidity rate, mortality rate.

Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

Transanal Versus Laparoscopic Total Mesorectal Excision for Mid And Low Rectal Cancer in China (TLTME): a Single-center Randomized Clinical Trial

(the quality of the TME specimen, complete, near complete, incomplete)

the rate of positive circumferential resection margin (CRM)

morbidity rate(number of intr-and post-operative encountered cases)

(number of intr-and post-operative encountered complications)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer	NCT06147492	Rectal Cancer	transanal total... Laparoscopic To...	18 Years - 65 Years	Sun Yat-sen University
Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer	NCT02673177	Rectal Neoplasm...	robot-assisted ... laparoscopic to...	18 Years - 70 Years	Southwest Hospital, China
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer	NCT03413930	Rectal Cancer	Transanal total... Laparoscopic to...	18 Years - 80 Years	Ruijin Hospital
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).	NCT02488707	Rectal Cancer	laparoscopic in... Transanal minim...	18 Years -	Mansoura University
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer	NCT03413930	Rectal Cancer	Transanal total... Laparoscopic to...	18 Years - 80 Years	Ruijin Hospital
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer	NCT06147492	Rectal Cancer	transanal total... Laparoscopic To...	18 Years - 65 Years	Sun Yat-sen University
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer	NCT03359616	Rectal Cancer Surgery	Transanally cur... Laparoscopic to...	18 Years - 75 Years	Shanghai Minimally Invasive Surgery Center

Spots Global Cancer Trial Database for laparoscopic total mesorectal excision