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Yellinek et al. Mini-invasive Surg 2018;2:22 I http://dx.doi.org/10.20517/2574-1225.2018.17 Page 3 of 7
benign pathology. The overall anastomotic failure rate was 15.7% including early leak (7.8%), delayed leak
(2.0%), pelvic abscess (4.7%), anastomotic fistula (0.8%), chronic sinus (0.9%), and anastomotic stricture
(3.6%). Independent risk factors of anastomotic failure were male sex, obesity, smoking, diabetes mellitus,
tumors > 25 mm, excessive intraoperative blood loss, manual anastomosis, and prolonged operative time.
[14]
Koedam et al. assessed the patient-reported quality of life of 30 consecutive patients who underwent
TaTME for rectal cancer. Quality of life was assessed by three questionnaires: Overall Quality of Life (EQ-
5D-3L), Colorectal Cancer Specific Quality of Life (EORTC: QLQ-C30 and QLQ-CR29) and Anterior Re-
section Syndrome (LARS) scale. Outcomes of the questionnaires at 1 and 6 months were compared with
preoperative (baseline) values. Deterioration for all domains was mainly observed at 1 month after surgery
compared to baseline, but most outcomes had returned to baseline at 6 months. Social function and anal
pain remained significantly worse at 6 months compared to baseline. Major LARS (score > 30) was 33% at
6 months after ileostomy closure. End colostomies were not required in any patients. The authors con-
cluded that TaTME is associated with acceptable quality of life and functional outcome at 6 months after
surgery comparable to published results after conventional laparoscopic low anterior resection.
[15]
Marks et al. reported the long-term outcomes of 373 patients with rectal cancer underwent TaTME.
Ninety six percent of TME specimens were complete/near complete, 94% had a negative circumferential
resection margin, and 98.6% had a negative distal margin. Perioperative morbidity and mortality rates were
13.4% and 0.3%, respectively. The median follow up was 5.5 years. Overall local recurrence, distal metasta-
sis, and 5-year survival was 7.4%, 19.5%, and 90%, respectively.
[16]
In a case matched study that included 300 patients, Perdawood et al. compared TaTME (n = 100), laparo-
scopic TME (LaTME; n = 100), and open TME (OpTME; n = 100). The authors reported that TME resulted
in lower rates of incomplete TME specimens than LaTME, but not OpTME (P = 0.016, P = 0.750, respec-
tively). The rates of CRM involvement, mean CRM distance, and the percentages of successful surgery
were comparable among the three groups (P = 0.368). The conversion to open surgery occurred only in the
LaTME group. TaTME resulted in shorter operation time and less blood loss than the other two groups (P
< 0.001 and P < 0.001). Hospital stay was shorter in the TaTME group (P = 0.002); complication rate and
mortality were comparable among the groups.
The COLOR III randomized controlled trial is being conducted to evaluate the role of TaTME in rectal
cancer and to assess oncological outcomes. It has been designed to compare short- and long-term outcomes
of transanal and laparoscopic TME for mid and low rectal cancer. A total of 1098 consecutive patients
scheduled for resection of a mid or low rectal carcinoma will be included. The distal border of the tumor
has to be within 10 cm of the anal verge on MRI scan. Exclusion criteria are T1 tumors that can be treated
by local excision, tumors with ingrowth in the internal sphincter or levator ani muscle, and all T4 tumors.
All participating centers in the COLOR III trial will keep the coordinating center informed of all patients
[17]
presenting with rectal cancer .
The ETAP-GRECCAR 11 randomized controlled trial is also comparing TaTME to laparoscopic TME.
Patients with T3 lower-third rectal adenocarcinomas for whom conservative surgery with manual coloanal
anastomosis is planned will be recruited. The study is designed as a non-inferiority trial with a main crite-
rion of R0/R1 resection. The inclusion period will be 3 years, and every patient will be followed for 3 years.
[18]
The number of patients needed is 226 .
The US Multicenter study of TaTME with laparoscopic assistance for rectal cancer is a single arm feasibility
trial sponsored by the Society of American Gastrointestinal and Endoscopic Surgeons and the American
Society of Colon and Rectal Surgeons. The primary investigator, Patricia Sylla, aims to enroll 100 patients
from 11 sites.