Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
NCT ID: NCT03718351
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
236 participants
INTERVENTIONAL
2018-09-24
2021-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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transanal endoscopic microsurgery
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.
transanal endoscopic microsurgery
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.
endoscopic submucosal dissection
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.
endoscopic submucosal dissection
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.
Interventions
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transanal endoscopic microsurgery
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.
endoscopic submucosal dissection
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.
Eligibility Criteria
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Inclusion Criteria
* Have signed approved informed consent form for the study
* preoperative stage uT0 and/or uT1, mrT0 and/or mrT1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
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Rybakov Evgeny, MD
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
Locations
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State Scientific Centre of Coloproctology
Moscow, , Russia
Countries
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Central Contacts
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References
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Rybakov E, Chernyshov S, Likutov A, Khomiakov E, Yugai O, Alekseev M, Maynovskaia O, Tarasov M, Achkasov S. The results of randomized controlled trial comparing effectiveness of transanal endoscopic microsurgery versus endoscopic submucosal dissection. Surg Endosc. 2025 Oct 24. doi: 10.1007/s00464-025-12319-7. Online ahead of print.
Other Identifiers
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104a
Identifier Type: -
Identifier Source: org_study_id
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