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

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03718351

Enrollment

236

Registered

2018-10-24

Start date

2018-09-24

Completion date

2021-09-24

Last updated

2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Rectal Cancer, Large Rectal Adenomas

Keywords

Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery

Brief summary

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.

Interventions

PROCEDUREtransanal 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.

PROCEDUREendoscopic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
R0 resection rate	14 day
En-block resesction rate	14 day

Secondary

Measure	Time frame
Incidence of locoregional recurrence	12 months
Morbidity defined by the Clavien-Dindo classification	30 day

Countries

Russia

Contacts

Primary ContactStanislav Chernyshov, MD

stchernyshov@gmail.com+7 499 199 86 43

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026