Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
NCT ID: NCT02406118
Last Updated: 2021-09-10
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
49 participants
INTERVENTIONAL
2015-03-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
Transanal total mesorectal excision
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Interventions
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Transanal total mesorectal excision
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. biopsy-proven adenocarcinoma of the rectum
3. clinical staging (c or yc): T0-3, N0-2, M0
4. Rectal cancer located 3-12 cm from the anal verge
5. ECOG performance status: 2 or less
6. BMI: less than 30
Exclusion Criteria
2. Obstructing rectal cancer
3. Pregnant or breast-feeding
4. Receiving any other study agents
5. Fecal incontinence
6. History of prior colorectal cancer or inflammatory bowel disease
7. Tumor size: more than 7cm in long diameter
8. CRM: mesorectal fascia involvement or less than 1 mm on MRI
20 Years
80 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Dae Kyung Sohn
MD., PHD, Center for Colorectal Cancer
Principal Investigators
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Dae Kyung Sohn
Role: PRINCIPAL_INVESTIGATOR
NCC,Korea
Locations
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National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Countries
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References
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Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.
Other Identifiers
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NCC2015-0033
Identifier Type: -
Identifier Source: org_study_id
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