Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)

Completed · Phase 4

Conditions studied: Obstructive Defecation Syndrome, Chronic Constipation, Rectocele, Intussusception

In brief

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).

Key facts

Study ID

NCT00256984

Run by

Ethicon Endo-Surgery

People needed

75

Starts

2005-10-01

Expected to finish

2008-06-01

Last updated by the study team

2018-07-16

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Colon and Rectal Clinic of Orlando — Orlando, Florida, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Colon & Rectal Surgery Associates Ltd. — Minneapolis, Minnesota, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Medical University of Ohio, Department of Surgery — Toledo, Ohio, United States
• Portland Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.