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

NCT03253302 | Unknown

• 1 other identifier: CR-TaTME
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

transanal surgery; total mesorectal excision; rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The grade score of the specimens integrity

  10 days after surgery

• The distance between lower tumor margin and the lower reaction margin

  10 days after surgery

• local recurrence rate

  3 years after surgery

• the operative time

  30 days after surgery

• postoperative hospital stay

  3 year after surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Peking University People's Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Ruijin Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• Liaoning Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant dean, professor

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 17, 2017
• Study Start: October 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

CN (1)