Rectal Neoplasms Clinical Trial
Official title:
Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial
This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.
Background: Transanal minimally invasive surgery (TAMIS) is an effective surgical alternative
to transanal excision for treating early rectal neoplasms not amenable to en bloc resection
by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a
revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms
with low morbidity. To date, no randomized controlled trial can be found in the literature
comparing the two modalities.
Objectives: To compare the short-term clinical outcomes, functional outcomes, costs, and
recurrence rates between ESD and TAMIS for early rectal neoplasms.
Design: Prospective randomized controlled trial.
Subjects: One hundred and fourteen consecutive patients diagnosed with early rectal neoplasms
(>/=2 cm in size and without evidence of deep submucosal invasion) that are not amenable to
en bloc resection by conventional colonoscopic techniques will be recruited.
Interventions: Patients will be randomly allocated to receive either ESD or TAMIS.
Outcome measures: Primary outcome: 30-day morbidity/mortality defined by the Clavien-Dindo
classification. Secondary outcomes: hospital stay, functional outcomes and quality of life,
overall costs, R0 resection rate, and recurrence rate.
Conclusions: Results of the present study can provide evidence-based clarification of the
efficacy and safety of ESD in treating early rectal neoplasms. The Investigators hypothesize
that ESD is associated with lower morbidity, shorter hospital stay, and similar R0 resection
rate when compared with TAMIS. A faster recovery and earlier discharge after ESD may reduce
financial burden to the hospital/healthcare system. The results of this proposed project may
have a significant impact on the future treatment strategy for early rectal neoplasms.
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