Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04058223
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2019-08-14
Brief Title:
Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Taipei Medical University Shuang Ho Hospital
Study Overview
Official Title:
Taipei Medical University Shuang-Ho Hospital
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The hemorrhoidal disease affects approximately 44-36 of the general population and it has been estimated that 50 of the population aged 50 years experiences hemorrhoidal problems Traditional hemorrhoidectomy including Milligan-Morgan Ferguson and Whitehead procedures are known to cause significant postoperative pain and discomfort and result in a poor quality of life after operation Since the first introduction of the novel procedure hemorrhoidopexy by Longo in 1998 it has been considered as a safe procedure causing less postoperative pain and resulting in earlier recovery furthermore the patients are able to resume their normal daily life and work The PPH stapler Ethicon Endo-Surgery Inc Cincinnati OH USA was also first introduced in 1998 as a device to perform this procedure Subsequently a new device the DST stapler Covidien Mansfield MA USA was introduced in 2008 with some structural differences including a detachable anvil three anchor points over different levels a larger case and different agraffe sizes
However the majority of current studies have been focusing on the use of PPH stapler for hemorrhoidopexy and comparison with the DST stapler has been rarely discussed One randomized controlled trial that compared between the PPH stapler and the DST stapler reported that the DST stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse however that trial focused only on bleeding among the postoperative complications Currently only a limited number of studies have compared these two devices in terms of pain complications and anorectal stricture incidence rate The present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were treated with either the PPH or the DST stapler The specimen surface area and the relationships with complications were also analyzed
However the majority of current studies have been focusing on the use of PPH stapler for hemorrhoidopexy and comparison with the DST stapler has been rarely discussed One randomized controlled trial that compared between the PPH stapler and the DST stapler reported that the DST stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse however that trial focused only on bleeding among the postoperative complications Currently only a limited number of studies have compared these two devices in terms of pain complications and anorectal stricture incidence rate The present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were treated with either the PPH or the DST stapler The specimen surface area and the relationships with complications were also analyzed
Detailed Description:
None
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