Phase 4
N=75
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Obstructive Defecation Syndrome · Chronic Constipation · Rectocele · Intussusception
Bottom Line
View on ClinicalTrials.gov: NCT00256984 ↗Enrolled (actual)
75
Serious AEs
18.7%
Results posted
Apr 2011
Primary outcome: Primary: Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure — 60.8 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure |
60.8 | — |
| SECONDARY Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure |
-50.7 | — |
| SECONDARY Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). |
1.43 | — |
| SECONDARY Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) |
-57.0 | — |
| SECONDARY PAC QOL Patient Assessment of Constipation (Overall) |
0.95 | — |
| SECONDARY SF-12 QOL Change From Baseline (Physical Component)at 12 Months |
6.32 | — |
| SECONDARY SF-12 QOL Change (Mental Component) at 12 Months From Baseline |
4.83 | — |
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).
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00256984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.