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Published on: February 12, 2022
The results of randomized controlled trial comparing effectiveness of transanal endoscopic microsurgery versus
Evgeny Rybakov1, Stanislav Chernyshov2, Aleksey Likutov2
1Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russia. erybakov@gmail.com.
Background:
Comparison of Transanal Endoscopic Microsurgery (TEM) and Endoscopic Submucosal Dissection (ESD) is based only on retrospective studies. With the aim of comparing the effectiveness of TEM and ESD, a single-center randomized clinical trial (RCT) registered at ClinicalTrials.gov NCT03718351 was undertaken.
Patients And Methods:
patients with rectal adenomas ≥ 3 cm were randomized (1:1) to TEM or ESD. The primary outcome was R0 resection rate, the secondary end-points were en bloc resection rate, perioperative morbidity and 2-year recurrence rate.
Results:
between 2018 and 2023, 236 patients were included into the ESD or TEM group (n = 118 each). One patient (0.8%) from the ESD group had conversion to the TEM one. The mean size of lesions was 4.2 cm in the TEM vs. 4.1 cm in the ESD group (p = 0.39). Perioperative complications (> II by Clavien-Dindo) developed in 20/118 (16.9%) patients after TEM vs. 18/118 (15.2%) patients after ESD (p = 0.9). R0 resection and en bloc removal were 79.7% and 97.5% after TEM versus 67.5% and 85.6% after ESD (p = 0.04 and p = 0.002, respectively). Completion surgery performed in 9 (7.6%) and 6 (5.1%) cases, respectively. Those patients were excluded from an analysis of long-term results. Thirty-six patients from the TEM and 48 from the ESD group were lost for the follow up. After at least two-year surveillance, the recurrence rate was identical between the groups: 4/73 (5.4%) in TEM vs. 3/63 (4.8%) in ESD (p = 1.0).
Conclusion:
TEM resulted in a higher R0 and en bloc resection rate comparing to ESD; no difference in the recurrence rate was demonstrated.
