Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04169152
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2019-11-13
Brief Title:
CAES for Internal Hemorrhoids and Rectal Prolapse
Sponsor:
Faming Zhang
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse a National Multi-centre Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
None
Brief Summary:
Cap-assisted endoscopic sclerotherapy CAES is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy However the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies Therefore a nationwide multi-center large sample prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse to provide reliable evidence for popularization of this minimally invasive technology
Detailed Description:
CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method Firstly the cap added to the front of colonoscope can fully expose the operating field Secondly before or during the opportunity of CAES endoscopist can perform endoscopic differentiation diagnosis such as tumors inflammatory bowel disease and others induced hematochezia endoscopic therapy within lower-gut based on the same colon preparation thus saving patients medical cost physical and mental pain The last but not least specially designed length of endoscopic injection needle eg10-20 mm was used in CAES could be helpful for accurately controlling the injection angle direction depth under direct vision and to avoid iatrogenic injury due to ectopic injectionThe core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy reduce the iatrogenic injuries avoid pain during and after therapy Our pilot studies demonstrated that CAES based on long injection needle is an effective safe convenient operation technique 100 of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up with no severe or obvious complications related to CAES However the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None