Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
Early Rectal Cancer, Large Rectal Adenomas
About this trial
This is an interventional treatment trial for Early Rectal Cancer focused on measuring Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery
Eligibility Criteria
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
Sites / Locations
- State Scientific Centre of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
transanal endoscopic microsurgery
endoscopic submucosal dissection
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.
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.