Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.

The intestinal wall was sutured to ensure the integrity of the bowel.

According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.

Transanal surgery could Preserve anus to reduce trauma and improve the quality of life

transanal surgery

Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.

Miles surgery

After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.

Preoperative chemoradiotherapy

rui zhang, doctor

xin liu, master

Rui Zhang, doctor

peirong ding, doctor

ji zhu, doctor

zhenning wang, doctor

hong zhang, doctor

yu han, doctor

zhaocheng chi, doctor

quan wang, doctor

ge liu, doctor

hang lu, doctor

zheng liu, doctor

rui Zhang, doctor

The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.

Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study

The level of carcinoembryonic antigen in blood

The level of carbohydrate antigen 19-9 in blood

Describe the function of Erectile ,only for male patients

Describe the function of prostate,only for male patients

Describe the function of sexual for female patients

Describe the quality of life for tumor patients

Zhang Rui

Head of colorectal surgery,clinical professor

Colonic Diseases

Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation.

Navigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation.

Conventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the "surgical" anatomical point and its correspondent on the images of the navigation platform.

Intraoperative acquisition (robotic c-Arm) of images

Didier Mutter, MD, PhD

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

* In minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. Although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. Conventional imaging, such as magnetic resonance imaging (MRI) and computed tomography (CT-scan), can provide a detailed view of 2D or 3D internal anatomical structures. However, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). For this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto.
* The proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. The study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. Benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients.
* Surgical navigation will be performed on the basis of preoperative images or intraoperative images.

Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

Measurement of "accuracy" of surgical navigation defined as the distance measured between the position of "surgical" previously defined anatomical landmarks, pointed with a surgical instrument tracked by the navigation system, and corresponding location of the instrument in the navigation image. A distance equal to or less than 4 mm between the two locations will be considered as an optimum accuracy.

Usefulness of intraoperative images acquisition for the registration process of the navigation system by comparing accuracy of surgical navigation (in mm) with or without intraoperative images acquisition

Measurement of "registration error" during surgical navigation defined as the difference between the alignment of the geometric position of the markers in the image space and the actual physical space, with or without intraoperative images acquisition. An error of 2 mm during the recording process will be considered as the optimal parameter

Evaluation of the impact of the introduction of surgical navigation on the operating time. The measurement of the overall operating time (expressed in minutes), associated with surgical navigation

Evaluation of the impact of the introduction of surgical navigation on the exposure of the patient to ionizing radiation, measured with Dose Length Product (DLP) and expressed in mGy \* cm

Evaluation of the impact of the introduction of surgical navigation on the incidence of intra- and / or postoperative complications associated with surgical navigation

IHU Strasbourg

At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.

Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site

Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)

Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.

shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.

shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.

show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.

preoperative safety containing operation information, complication information.

quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.

Peking Union Medical College Hospital

Peking University People's Hospital

Peking University Cancer Hospital & Institute

Ruijin Hospital

The First Hospital of Jilin University

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

Liaoning Cancer Hospital & Institute

Beijing Friendship Hospital

assistant dean, professor

Laparoscopy-assisted transanal total mesorectal excision

Transanal total mesorectal excision

Jae Hwan Oh, MD, PHD

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

The quality of the mesorectum was determined using pathology reports and scored using three grades:

* Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
* Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
* Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.

National Cancer Center, Korea

Head of Center for Colorectal Cancer, National Cancer Center

Herbal and Botanical

All Drugs and Chemicals

Cola

A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.

A minimally-invasive technique in which operations are performed via small incisions (usually 0.5-1.5 cm) at a location distant to the site of interest.

A minimally-invasive approach that allows good precision, flexibility, and control.

Where the protectomy is performed down to up until the Douglas pouch

Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME

TME with LAR

Philippe ROUANET, MD

Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique. Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, TME grade III, and minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions.

Rectal Surgery Evaluation Trial (RESET)

Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

CRM, TME grade III, The absence of clavien dindo grade III-IV complications within 30 days post op

Intuitive Surgical

Institut du Cancer de Montpellier - Val d'Aurelle

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

Laparoscopic 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
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients	NCT03431428	Almost-cCR Surgery Rectal Cancer	transanal surge... Miles surgery Preoperative ch...	18 Years - 75 Years	Liaoning Tumor Hospital & Institute
Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer	NCT03806244	Colorectal Canc...	Intraoperative ...	18 Years -	IHU Strasbourg
Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site	NCT03253302	Rectal Cancer		18 Years - 80 Years	Beijing Friendship Hospital
The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision	NCT01938027	Rectal Cancer	Transanal total...	20 Years - 80 Years	National Cancer Center, Korea
Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer	NCT03806244	Colorectal Canc...	Intraoperative ...	18 Years -	IHU Strasbourg
Rectal Surgery Evaluation Trial (RESET)	NCT03574493	Rectal Cancer	TME with LAR	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
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 transanal surgery