Clinical trial NCT03253302: Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site
Official title: Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: transanal surgery
total mesorectal excision
rectal cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University People's Hospital
name: Peking University Cancer Hospital & Institute
name: Ruijin Hospital
name: The First Hospital of Jilin University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Liaoning Cancer Hospital & Institute
First posted: 2017-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive rate of circumferential resection margin (CRM) of the specimens
timeFrame: 10 days after surgery
Secondary outcomes:
measure: The grade score of the specimens integrity
timeFrame: 10 days after surgery
measure: The distance between lower tumor margin and the lower reaction margin
timeFrame: 10 days after surgery
measure: local recurrence rate
timeFrame: 3 years after surgery
measure: the operative time
timeFrame: 30 days after surgery
measure: postoperative hospital stay
timeFrame: 3 year after surgery
measure: the score of postoperative life
timeFrame: 6 months after surgery
measure: disease free survival rate
timeFrame: 3-year after surgery
measure: overall survival rate
timeFrame: 3-year after surgery
measure: the rate of postoperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: