Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT00635466
Status:
UNKNOWN
Last Update Posted:
2011-06-16
First Post:
2008-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Sponsor:
Japan Society of Laparoscopic Colorectal Surgery
Organization:
Study Overview
Official Title:
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lap RC
Brief Summary:
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Detailed Description:
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCCHCT19-49 | None | None | View |