Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site (LATERAL-01)

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

lower rectal cancer patients who are suitable and willing to accept laparoscopy- assisted TME procedure and also agree with the trial

Description

Inclusion Criteria:

• adenocarcinoma of the rectum by biopsy
• the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
• tumor diameter less than 4cm
• baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
• tolerable to surgery
• be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

• history of malignant colorectal neoplasia
• recent diagnosis with other malignancies
• patients requiring emergency surgery such as obstruction，perforation and bleeding
• tumor involving adjacent organs, anal sphincter, or levator ani muscle
• muti-focal colorectal cancer
• preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
• history of inflammatory bowel disease or familial adenomatous polyposis
• participating in other clinical trails
• can not tolerate the surgery
• history of serious mental illness
• pregnancy or lactating women
• preoperative uncontrolled infection
• the researchers believe the patients should not enrolled in

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of circumferential resection margin (CRM) of the specimens	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.	10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The grade score of the specimens integrity	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.	10 days after surgery
The distance between lower tumor margin and the lower reaction margin	shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.	10 days after surgery
local recurrence rate	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.	3 years after surgery
the operative time	preoperative safety containing operation information, complication information.	30 days after surgery
postoperative hospital stay	recovery information.	3 year after surgery
the score of postoperative life	quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.	6 months after surgery
disease free survival rate	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.	3-year after surgery
overall survival rate	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.	3-year after surgery
the rate of postoperative complications	preoperative safety containing operation information, complication information.	30 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking University People's Hospital; Peking Union Medical College 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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: rectal cancer; total mesorectal excision; transanal surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CR-TaTME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No