Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04981600
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-28
First Post:
2021-07-04
Brief Title:
Radiofrequency Ablation vs Laser Hemorrhoidoplasty Procedure for Hemorrhoidal Disease
Sponsor:
Umraniye Education and Research Hospital
Organization:
Umraniye Education and Research Hospital
Study Overview
Official Title:
Radiofrequency Ablation vs Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease Prospective Randomised Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
Hemorrhoids which can be defined as vascular cushions located at the anorectal junction constitute an important part of the physiological continence mechanism However under various pathological conditions they can expand below the dentate line and consequently are defined as hemorrhoidal disease which is characterized by various symptoms such as bleeding pain and itching An ideal treatment should be effective in the long term require less intervention to the surrounding structures have low morbidity rates and cause minimal postoperative pain which significantly affects the quality of life of a patient following surgery he aim of this study is to compare the two contemporary minimally invasive methods
Detailed Description:
Hemorrhoids which can be defined as vascular cushions located at the anorectal junction constitute an important part of the physiological continence mechanism However under various pathological conditions they can expand below the dentate line and consequently are defined as hemorrhoidal disease which is characterized by various symptoms such as bleeding pain and itching The indication of treatment depends primarily on the individual burden of the disease rather than its stage An ideal treatment should be effective in the long term require less intervention to the surrounding structures have low morbidity rates and cause minimal postoperative pain which significantly affects the quality of life of a patient following surgery Although conventional resection based techniques have less recurrence rates they tend to have a greater chance of leading to various postoperative complications such as significant postoperative pain urinary retention bleeding abscess formation anal stenosis anal fissure and fecal incontinence deeming non-resection based less invasive techniques more favorable in terms of postoperative morbidity The main mechanism of non-resection based techniques is creating an inflammatory stimulus inside the prolapsed hemorrhoidal tissue which ultimately causes fibrosis and relocation of the tissue above the dentate line There are several randomized controlled trials which compared the laser procedure especially with resection based methods in this regard However to our knowledge which is based on a thorough search in the Pubmed and Google Scholar no randomized clinical trial has been made comparing the radiofrequency ablation method with the laser ablation technique
The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications recovery process and postoperative pain
The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications recovery process and postoperative pain
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