Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Study Overview
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Brief Summary
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Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.

Official Title
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Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Conditions
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Early Rectal Cancer, Large Rectal Adenomas

Intervention / Treatment
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* Procedure: transanal endoscopic microsurgery
* Procedure: endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively. Have signed approved informed consent form for the study preoperative stage uT0 and/or uT1, mrT0 and/or mrT1 Exclusion Criteria: non-epithelial tumors tumors </= 3 cm in size recurrent tumors suspicion of lymph node metastasis (N + disease) preoperative stage uT2 and/or mrT2 mucous or low-grade adenocarcinoma preoperative stage rM1 and/or uM1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transanal endoscopic microsurgery<br>a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital. | Procedure: transanal endoscopic microsurgery<br>* a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.<br>|
| Experimental: endoscopic submucosal dissection<br>an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital. | Procedure: endoscopic submucosal dissection<br>* an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | 14 day | 
| En-block resesction rate |  | 14 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of locoregional recurrence |  | 12 months | 
| Morbidity defined by the Clavien-Dindo classification |  | 30 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery