November 18, 2005 |
March 7, 2011 |
October 2005 |
March 2008 (final data collection date for primary outcome measure) |
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure [ Time Frame: one year from Baseline ] [ Designated as safety issue: No ] The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure. |
- Percent change in total ODS symptom composite score one year post procedure. |
Complete list of historical versions of study NCT00256984 on ClinicalTrials.gov Archive Site |
- Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure [ Time Frame: Baseline, 1 month post procedure ] [ Designated as safety issue: No ]
Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.
- Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.
- Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) [ Time Frame: Baseline, 6 months post procedure ] [ Designated as safety issue: No ]
The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
- PAC QOL Patient Assessment of Constipation (Overall) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol
- SF-12 QOL Change From Baseline (Physical Component)at 12 Months [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
- SF-12 QOL Change (Mental Component) at 12 Months From Baseline [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.
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- - Percent change in ODS symptom composite score from baseline at 1-month, 6-month, 2-year, 3 year, 4-year and 5 years.
- - Change in patient condition scores from baseline at 1-month, 6-months, 1-year, 2-year, 3-year, 4 year and 5-years, to be assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM), and quality of life (PAC-QOL and SF-12).
- - Change from baseline in urge to defecate.
- - Change from baseline in dynamic defecography parameters (including anterior rectocele depth, anteroposterior diameter of rectum) at rest and during evacuation at 6-months postoperative.
- - Global assessment of change in bowel condition by both the investigator and the subject.
- - Patient Surgery Satisfaction Assessment at 1-month, 6-months, and 1-year postoperative.
- - Change from baseline in anorectal pain at onset of defecation at 1-month postoperative.
- -Incidence of dyspareunia at baseline, 1-month, 6-month, and 1 year postoperative.
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Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) |
A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS) |
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). |
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 symptoms/factors 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 intussusception/rectocele, 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. |
Interventional |
Phase 4 |
Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
- Obstructive Defecation Syndrome
- Chronic Constipation
- Rectocele
- Intussusception
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Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler |
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- Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989 Dec;30(12):1737-49.
- Kenton K, Shott S, Brubaker L. The anatomic and functional variability of rectoceles in women. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(2):96-9.
- Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Functional constipation and outlet delay: a population-based study. Gastroenterology. 1993 Sep;105(3):781-90.
- Siproudhis L, Dautreme S, Ropert A, Briand H, Renet C, Beusnel C, Juguet F, Rabot AF, Bretagne JF, Gosselin M. Anismus and biofeedback: who benefits? Eur J Gastroenterol Hepatol. 1995 Jun;7(6):547-52.
- van Dam JH, Hop WC, Schouten WR. Analysis of patients with poor outcome of rectocele repair. Dis Colon Rectum. 2000 Nov;43(11):1556-60.
- Fleshman JW, Fry RD, Kodner IJ. The surgical management of constipation. Baillieres Clin Gastroenterol. 1992 Mar;6(1):145-62. Review.
- Altomare DF, Rinaldi M, Veglia A, Petrolino M, De Fazio M, Sallustio P. Combined perineal and endorectal repair of rectocele by circular stapler: a novel surgical technique. Dis Colon Rectum. 2002 Nov;45(11):1549-52.
- Dodi G, Pietroletti R, Milito G, Binda G, Pescatori M. Bleeding, incontinence, pain and constipation after STARR transanal double stapling rectotomy for obstructed defecation. Tech Coloproctol. 2003 Oct;7(3):148-53.
- Boccasanta P, Venturi M, Stuto A, Bottini C, Caviglia A, Carriero A, Mascagni D, Mauri R, Sofo L, Landolfi V. Stapled transanal rectal resection for outlet obstruction: a prospective, multicenter trial. Dis Colon Rectum. 2004 Aug;47(8):1285-96; discussion 1296-7.
- Boccasanta P, Venturi M, Salamina G, Cesana BM, Bernasconi F, Roviaro G. New trends in the surgical treatment of outlet obstruction: clinical and functional results of two novel transanal stapled techniques from a randomised controlled trial. Int J Colorectal Dis. 2004 Jul;19(4):359-69. Epub 2004 Mar 13.
- Pescatori M, Dodi G, Salafia C, Zbar AP. Rectovaginal fistula after double-stapled transanal rectotomy (STARR) for obstructed defaecation. Int J Colorectal Dis. 2005 Jan;20(1):83-5. Epub 2004 Sep 2. No abstract available.
- Grassi R, Romano S, Micera O, Fioroni C, Boller B. Radiographic findings of post-operative double stapled trans anal rectal resection (STARR) in patient with obstructed defecation syndrome (ODS). Eur J Radiol. 2005 Mar;53(3):410-6.
- Mongardini M, Custureri F, Schillaci F, Cola A, Maturo A, Fanello G, Corelli S, Pappalardo G. [Prevention of post-operative pain and haemorrhage in PPH (Procedure for Prolapse and Hemorrhoids) and STARR (Stapled Trans-Anal Rectal Resection). Preliminary results in 261 cases] G Chir. 2005 Apr;26(4):157-61. Italian.
- Binda GA, Pescatori M, Romano G. The dark side of double-stapled transanal rectal resection. Dis Colon Rectum. 2005 Sep;48(9):1830-1; author reply 1831-2. No abstract available.
- Jayne DG, Finan PJ. Stapled transanal rectal resection for obstructed defaecation and evidence-based practice. Br J Surg. 2005 Jul;92(7):793-4. No abstract available.
- Talley NJ, Phillips SF, Wiltgen CM, Zinsmeister AR, Melton LJ 3rd. Assessment of functional gastrointestinal disease: the bowel disease questionnaire. Mayo Clin Proc. 1990 Nov;65(11):1456-79.
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Completed |
75 |
June 2008 |
March 2008 (final data collection date for primary outcome measure) |
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
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Female |
21 Years to 80 Years |
No |
Contact information is only displayed when the study is recruiting subjects |
United States |
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NCT00256984 |
CI-05-0004 |
No |
Susan Knippenberg, Manager Clinical Affairs, Ethicon Endo-Surgery |
Ethicon Endo-Surgery |
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Study Director: |
Robin F Scamuffa, MS |
Ethicon Endo-Surgery |
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Study Director: |
William Bernie, MD |
Ethicon Endo-Surgery |
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Principal Investigator: |
Anthony J Senagore, MD |
Medical University of Ohio |
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Principal Investigator: |
Anders F Mellgren, MD, PhD |
University of Minnesota - Clinical and Translational Science Institute |
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Ethicon Endo-Surgery |
March 2011 |