Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated… (NCT00256984) | Clinical Trial Compass
CompletedPhase 4
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
United States75 participantsStarted 2005-10-01
Plain-language 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).
Who can participate
Age range21 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 concurrentl…
What they're measuring
1
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure