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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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2021-09-24

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.

Detailed Description

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Conditions

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Early Rectal Cancer Large Rectal Adenomas

Keywords

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Transanal endoscopic microsurgery Endoscopic submucosal dissection Minimally invasive surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

transanal endoscopic microsurgery

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

endoscopic submucosal dissection

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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State Scientific Centre of Coloproctology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Stanislav Chernyshov, MD

Role: CONTACT

Phone: +7 499 199 86 43

Email: [email protected]

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.

Reference Type DERIVED
PMID: 41136652 (View on PubMed)

Other Identifiers

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104a

Identifier Type: -

Identifier Source: org_study_id