An observational study in Rectal Cancer, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Beijing Friendship Hospital · Observational
Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer. However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal total mesorectal excision (TaTME) might serve as a better procedure for these patients, for it might ease the dissection of the low mesorectum. So far, several studies have showed the promising results of TaTME, but the multi-center data in China is still lacking. This nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data on the safety and efficacy of this procedure in Chinese patients with rectal cancer and encouraging future research in this field.
patients with middle-lower rectal neoplasms who are suitable and willing to accept TaTME procedure and also agree with the registry
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
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
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 incidence of postoperative complications
the incidence of postoperative complications after transanal total mesorectal excision.
Time frame: 30 days after surgery
the severity of postoperative complication assessed by Clavien Dindo grade
the severity of postoperative complication after transanal total mesorectal assessed by Clavien Dindo grade
Time frame: 30 days after surgery
the grade of anastomotic leakage
the grade of anastomotic leakage for patients who develop anastomotic leakage after transanal total mesorectal excision assessed by the grading system proposed by International Study Group of Rectal Cancer (ISREC).
Time frame: 30 days after surgery
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital