Obstructive Defecation SyndromePhase 4NCT00256984
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
A Phase 4 study testing Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler in people with Obstructive Defecation Syndrome and Chronic Constipation, run by Ethicon Endo-Surgery at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Obstructive Defecation Syndrome, Chronic Constipation, Rectocele
- What is being tested?
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2005to 1 Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lahey Clinic
Burlington, Massachusetts, 01805
University Hospitals of Cleveland
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colon & Rectal Surgery Associates Ltd.
Minneapolis, Minnesota, 55454
Colon and Rectal Clinic of Orlando
Orlando, Florida, 32806
Portland Medical Center
Portland, Oregon, 97205
Medical University of Ohio, Department of Surgery
Toledo, Ohio, 43614
About this study
Official title: 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).
Read the 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, 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.
- Being tested
- Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
- Keywords
- Obstructive Defecation Syndrome, Colorectal Surgery, Defecography, Constipation, Rectocele, Intussusception, Quality of Life
- Medical subject headings
- Rectocele, Intussusception, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular StaplerProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
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.
Measured: one year from Baseline
Secondary outcomes (6)
Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure
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.
Measured: Baseline, 1 month post procedure
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
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.
Measured: Baseline, 6 months
Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)
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.
Measured: Baseline, 6 months post procedure
PAC QOL Patient Assessment of Constipation (Overall)
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
Measured: Baseline, 12 months
SF-12 QOL Change From Baseline (Physical Component)at 12 Months
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.
Measured: Baseline, 12 Months
SF-12 QOL Change (Mental Component) at 12 Months From Baseline
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.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study start1 Oct 2005
- Primary completion1 Mar 2008
- Study completion1 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Obstructive Defecation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin F Scamuffa, MS, Study director, Ethicon Endo-SurgeryWilliam Bernie, MD, Study director, Ethicon Endo-SurgeryAnthony J Senagore, MD, Principal investigator, Medical University of OhioAnders F Mellgren, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256984
- Sponsor's protocol ID
- CI-05-0004
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2005
- Last updated
- 16 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989 Dec;30(12):1737-49. doi: 10.1136/gut.30.12.1737.
PubMed 2612988Kenton 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. doi: 10.1007/pl00004019.
PubMed 10384970Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Functional constipation and outlet delay: a population-based study. Gastroenterology. 1993 Sep;105(3):781-90. doi: 10.1016/0016-5085(93)90896-k.
PubMed 8359649Siproudhis 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.
PubMed 7552638van Dam JH, Hop WC, Schouten WR. Analysis of patients with poor outcome of rectocele repair. Dis Colon Rectum. 2000 Nov;43(11):1556-60. doi: 10.1007/BF02236738.
PubMed 11089592Fleshman JW, Fry RD, Kodner IJ. The surgical management of constipation. Baillieres Clin Gastroenterol. 1992 Mar;6(1):145-62. doi: 10.1016/0950-3528(92)90024-9.
PubMed 1586766Altomare 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. doi: 10.1007/s10350-004-6465-9.
PubMed 12432306Dodi 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. doi: 10.1007/s10151-003-0026-4.
PubMed 14628157Boccasanta 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. doi: 10.1007/s10350-004-0582-3.
PubMed 15484341Boccasanta 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. doi: 10.1007/s00384-003-0572-2. Epub 2004 Mar 13.
PubMed 15024596Pescatori 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. doi: 10.1007/s00384-004-0658-5. Epub 2004 Sep 2. No abstract available.
PubMed 15349740Grassi 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. doi: 10.1016/j.ejrad.2004.12.012.
PubMed 15741014Mongardini 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.
PubMed 16035252Binda 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. doi: 10.1007/s10350-005-0103-z. No abstract available.
PubMed 15991070Jayne DG, Finan PJ. Stapled transanal rectal resection for obstructed defaecation and evidence-based practice. Br J Surg. 2005 Jul;92(7):793-4. doi: 10.1002/bjs.5092. No abstract available.
PubMed 15962257
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)
- ClinicalTrials.gov ID
- NCT00256984
- Acronym / sponsor ID
- CI-05-0004
- Keywords
- Obstructive Defecation Syndrome, Colorectal Surgery, Defecography, Constipation, Rectocele, Intussusception, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2005 (actual)
- Primary completion
- 1 Mar 2008 (actual)
- Study completion
- 1 Jun 2008 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Posted 7 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- Fecal incontinence to solid stool
- Full-thickness prolapse
- Perineal infection
- Recto-vaginal fistula
- Enterocele (at rest)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler | Procedure or surgery | – |
Primary outcome
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
Time frame: one year from Baseline
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.
6 secondary outcomes
Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure
Time frame: Baseline, 1 month post procedure
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
Time frame: Baseline, 6 months
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
PAC QOL Patient Assessment of Constipation (Overall)
Time frame: Baseline, 12 months
SF-12 QOL Change From Baseline (Physical Component)at 12 Months
Time frame: Baseline, 12 Months
SF-12 QOL Change (Mental Component) at 12 Months From Baseline
Time frame: Baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2612988Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989 Dec;30(12):1737-49. doi: 10.1136/gut.30.12.1737.
- Background: PubMed 10384970Kenton 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. doi: 10.1007/pl00004019.
- Background: PubMed 8359649Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Functional constipation and outlet delay: a population-based study. Gastroenterology. 1993 Sep;105(3):781-90. doi: 10.1016/0016-5085(93)90896-k.
- Background: PubMed 7552638Siproudhis 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.
- Background: PubMed 11089592van Dam JH, Hop WC, Schouten WR. Analysis of patients with poor outcome of rectocele repair. Dis Colon Rectum. 2000 Nov;43(11):1556-60. doi: 10.1007/BF02236738.
- Background: PubMed 1586766Fleshman JW, Fry RD, Kodner IJ. The surgical management of constipation. Baillieres Clin Gastroenterol. 1992 Mar;6(1):145-62. doi: 10.1016/0950-3528(92)90024-9.
- Background: PubMed 12432306Altomare 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. doi: 10.1007/s10350-004-6465-9.
- Background: PubMed 14628157Dodi 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. doi: 10.1007/s10151-003-0026-4.
- Background: PubMed 15484341Boccasanta 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. doi: 10.1007/s10350-004-0582-3.
- Background: PubMed 15024596Boccasanta 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. doi: 10.1007/s00384-003-0572-2. Epub 2004 Mar 13.
- Background: PubMed 15349740Pescatori 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. doi: 10.1007/s00384-004-0658-5. Epub 2004 Sep 2. No abstract available.
- Background: PubMed 15741014Grassi 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. doi: 10.1016/j.ejrad.2004.12.012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin F Scamuffa, MS study director
Ethicon Endo-Surgery
William Bernie, MD study director
Ethicon Endo-Surgery
Anthony J Senagore, MD principal investigator
Medical University of Ohio
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler in people with Obstructive Defecation Syndrome and Chronic Constipation, run by Ethicon Endo-Surgery at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256984, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.