An observational study in Rectal Cancer, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Beijing Friendship Hospital · Observational
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.
lower rectal cancer patients who are suitable and willing to accept laparoscopy- assisted TME procedure and also agree with the trial
Exclusion Criteria:
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.
Time frame: 10 days after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 years after surgery
the operative time
preoperative safety containing operation information, complication information.
Time frame: 30 days after surgery
postoperative hospital stay
recovery information.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-year after surgery
the rate of postoperative complications
preoperative safety containing operation information, complication information.
Time frame: 30 days after surgery
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital