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

Rectal Cancer Clinical Trial

— LATERAL-01  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03253302
• Other study ID #: CR-TaTME
• Status: Enrolling by invitation
• Start date: October 1, 2017
• Est. completion date: December 2021

Study information

• Verified date: August 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Cancer Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Hospital of Jilin University, Liaoning Cancer Hospital & Institute, Peking Union Medical College Hospital, Peking University People's Hospital, Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	the operative time	preoperative safety containing operation information, complication information.	30 days after surgery
Secondary	postoperative hospital stay	recovery information.	3 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	the rate of postoperative complications	preoperative safety containing operation information, complication information.	30 days after surgery