Status:
COMPLETED
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Obstructive Defecation Syndrome
Chronic Constipation
Eligibility:
FEMALE
21-80 years
Phase:
PHASE4
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 ...
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,...
Eligibility Criteria
Inclusion
- Able to comprehend, understand, and speak the English language
- Able to comprehend, follow, and sign an informed consent document (ICD)
- Able to tolerate general or spinal anesthetic
- Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
- Have experienced ODS symptoms for at least 12 months prior to enrollment
- Have a minimum ODS score of 10
- Have rectocele and/or rectal intussusception confirmed by defecography
- Screened for colorectal neoplasia within 7 years of the screening visit (e.g., colonoscopy or barium enema)
- Have an American Society of Anesthesiologists (ASA) score of no more than 3
- Willing to comply with evaluation and management schedule through 5-year follow-up
Exclusion
- Fecal incontinence to solid stool
- Full-thickness prolapse
- Perineal infection
- Recto-vaginal fistula
- Enterocele (at rest)
- Any complex pelvic floor prolapse requiring a combined surgical approach
- Prior sigmoid or anterior resection or prior rectal anastomosis
- Presence of foreign material adjacent to the rectum (e.g., vaginal mesh)
- Grade IV hemorrhoids
- Pregnancy
- Chronic narcotic use
- Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
- Physical or psychological condition which would impair study participation
- Unable or unwilling to attend follow-up visits and examinations
- Surgical procedure required concurrently with STARR
- Prior pelvic radiotherapy
- Failure to identify any anatomical or physiological abnormality in the evaluation
- Significant rectal fibrosis
- Anal stenosis precluding insertion of the stapling device
- Participation in any other investigational device or drug study 30 days prior to enrollment
- Presence or history of hepatitis B, hepatitis C, and/or HIV positive test
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00256984
Start Date
October 1 2005
End Date
June 1 2008
Last Update
July 16 2018
Active Locations (7)
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1
Colon and Rectal Clinic of Orlando
Orlando, Florida, United States, 32806
2
Lahey Clinic
Burlington, Massachusetts, United States, 01805
3
Colon & Rectal Surgery Associates Ltd.
Minneapolis, Minnesota, United States, 55454
4
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106