Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transanal endoscopic microsurgery | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transanal endoscopic microsurgery | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | 14 day | |
| En-block resesction rate | 14 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of locoregional recurrence | 12 months | |
| Morbidity defined by the Clavien-Dindo classification | 30 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stanislav Chernyshov, MD | Contact | +7 499 199 86 43 | stchernyshov@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Centre of Coloproctology | Recruiting | Moscow | 123423 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41136652 | Derived | 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. 2026 Jan;40(1):469-474. doi: 10.1007/s00464-025-12319-7. Epub 2025 Oct 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| endoscopic submucosal dissection | 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. |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067369 | Transanal Endoscopic Microsurgery |
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D000067368 | Transanal Endoscopic Surgery |
| D057605 | Natural Orifice Endoscopic Surgery |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011351 | Proctoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008866 | Microsurgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D003938 | Diagnostic Techniques, Digestive System |
Not provided
Not provided