Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613399
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Study of Multi-technology Integration Total Mesorectal Excision MTI-TME Versus Conventional Total Mesorectal Excision C-TME for the Treatment of Middle and Distal Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter prospective randomized controlled clinical trial of multi-technology integration total mesorectal excision MTI-TME versus conventional total mesorectal excision C-TME for the treatment of middle and distal rectal cancer
Detailed Description:
Currently laparoscopic total mesorectal excision TME has become the standard procedure for treating middle and distal rectal cancer Anastomotic leakage has always been one of the serious complications of TME surgery and Anastomotic leakage not only increases the hospital expenses but also brings physical discomfort and psychological pain to the patients Furthermore anastomotic leakage is associated with a heightened risk of anastomotic stenosis compromised bowel function delayed initiation of postoperative adjuvant therapy increased local recurrence rates post-surgery and diminished long-term survival outcomes A report from the Netherlands indicates that anastomotic leakage serves as an independent prognostic factor for overall survival in patients diagnosed with rectal cancer Prior studies have documented the incidence of anastomotic leakage to range between 36 and 21 attributable to a confluence of various factors including technical complications oncological considerations and the patient39s overall health status Among these determinants aspects such as blood supply adequacy tension at the site of anastomosis tissue quality and anatomical positioning of the rectum are widely recognized as significant risk factors for developing anastomotic leaksCurrently several strategies are employed to mitigate the incidence of anastomotic leakage including preoperative proctocolectomy anal decompression placement vertical transverse resection of the rectum and anastomotic reinforcement techniques In our clinical practice we have innovatively integrated multiple approaches 1 preservation of the left colic artery LCA 2 high-level resection of the inferior mesenteric vein IMV 3 standardized mobilization of the splenic flexure along with left lateral colon 4 multi-plane dissection of mesorectal flaps and 5 selective reinforcement at the anastomosis Our findings indicate that multi-technology integrated total mesorectal excision MTI-TME significantly reduces both preventive stoma rates and incidences of anastomotic leakage compared to conventional total mesorectal excision C-TME However there remains a lack of robust evidence-based medicine supporting MTI-TME39s advantages in treating middle and distal rectal cancer further research is urgently needed to provide additional clinical evidence
Study Oversight
Has Oversight DMC:
None
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?:
None