An interventional study of Transanal total mesorectal excision in Rectal Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Treatment
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.
Difficult case is defined as below;
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.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 12 is below the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
If any one of the following (1 or 2 or 3)
Exclusion Criteria:
Laparoscopy-assisted transanal total mesorectal excision
Procedure: Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
TME quality & circumferential resection margin (CRM)
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
Time frame: the day of surgery
30-day postoperative complications
The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient
Time frame: 1 month after surgery
Number of harvested Lymph Nodes
Time frame: the day of surgery
2-year local recurrence free survival
Time frame: 2 years after surgery
5-year overall survival
Time frame: 5 years after surgery
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea