Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer.

BACKGROUND

Total mesorectal excision has become the standard treatment for rectal cancer, and several investigators have shown that a transanal approach is a feasible option.

OBJECTIVE

This study aimed to evaluate the efficacy of transanal endoscopic total mesorectal excision in patients with rectal cancer.

DESIGN

This study was a prospective, single-arm phase II trial. It was registered on clinicaltrials.gov under identifier NCT02406118.

SETTINGS

Inpatients at a hospital specializing in oncology were selected.

PATIENTS

This prospective study enrolled 49 patients with rectal cancer located 3 to 12 cm from the anal verge who were scheduled to undergo radical surgery.

INTERVENTIONS

Laparoscopy-assisted transanal total mesorectal excision was performed.

MAIN OUTCOME MEASURES

The primary end point was total mesorectal excision quality and circumferential resection margin. Secondary end points included the number of harvested lymph nodes, operation time, and 30-day postoperative complications.

RESULTS

From March 2015 to April 2016, 32 men and 17 women with rectal cancer were enrolled. The mean age was 61.2 years, and mean BMI was 23.3 kg/m. The mean operating time was 158 minutes, and the mean estimated blood loss was 89.3 mL. There were no intraoperative complications and no conversions to open surgery. Successful treatment based on total mesorectal excision quality and circumferential resection margin was achieved in 45 patients (91.8%). Fifteen patients (30.6%) had 30-day postoperative complications, including 7 (14.3%) with anastomotic dehiscence, 5 (10.2%) with urinary retention, 2 (4.1%) with abdominal wound complications, and 1 (2.0%) with ileus. There was no postoperative mortality.

LIMITATIONS

This was a noncomparative single-arm trial conducted at a single institution.

CONCLUSIONS

Transanal endoscopic total mesorectal excision showed acceptable results based on perioperative and short-term oncologic outcomes. Further investigations are necessary to show the benefits and long-term outcomes of this procedure. See Video Abstract at http://links.lww.com/DCR/A563.