Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256984
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2005-11-18
Brief Title:
Study of Stapled Transanal Rectal Resection STARR Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome ODS
Sponsor:
Ethicon Endo-Surgery
Organization:
Ethicon Endo-Surgery
Study Overview
Official Title:
A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection STARR in the Treatment of Obstructed Defecation Syndrome ODS
Status:
COMPLETED
Status Verified Date:
2017-10
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 primary purpose of this study is to determine how effective and how durable STARR stapled transanal rectal resection surgery is in relieving symptoms of intractable constipation associated with obstructive defecation syndrome ODS
Detailed Description:
Rectocele and rectal intussusception are frequent findings in women but are often asymptomatic apart from anatomical defects which can be seen on vaginal examination They can be associated however with refractory constipation that may be best described by the terms Outlet Obstruction or Obstructive Defecation Syndrome ODS ODS is characterized by a symptom complex including the feeling of incomplete evacuation associated with the need to strain excessively and for external assistance digital mechanical or positional maneuvers enemas or suppositories to aid defecation Abdominal or rectal pain is also a common complaint Obstetric trauma is also recognized as a contributing factor However none of these symptomsfactors can be singled out to be pathognomonic for this problem ODS has a prevalence of approximately 12 in the general population
For individuals with ODS and related intussusceptionrectocele a variety of surgical techniques including abdominal vaginal transanal and perineal approaches have been devised The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators Recently a new surgical approach was developed by an Italian surgeon A Longo and has been evaluated in several European centers These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments and warrants further study The procedure is referred to as Stapled Transanal Rectal Resection STARR and this study will assess its effectiveness in a United States population
For individuals with ODS and related intussusceptionrectocele a variety of surgical techniques including abdominal vaginal transanal and perineal approaches have been devised The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators Recently a new surgical approach was developed by an Italian surgeon A Longo and has been evaluated in several European centers These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments and warrants further study The procedure is referred to as Stapled Transanal Rectal Resection STARR and this study will assess its effectiveness in a United States population
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