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Sponsored by: |
Ethicon Endo-Surgery |
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Information provided by: | Ethicon Endo-Surgery |
ClinicalTrials.gov Identifier: | NCT00256984 |
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).
Condition | Intervention | Phase |
---|---|---|
Obstructive Defecation Syndrome Chronic Constipation Rectocele Intussusception |
Procedure: Stapled Transanal Resection (STARR) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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) |
Estimated Enrollment: | 130 |
Study Start Date: | October 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Colon and Rectal Clinic of Orlando | |
Orlando, Florida, United States, 32806 | |
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 | |
United States, Minnesota | |
Colon & Rectal Surgery Associates Ltd. | |
Minneapolis, Minnesota, United States, 55454 | |
United States, Ohio | |
Medical University of Ohio, Department of Surgery | |
Toledo, Ohio, United States, 43614 | |
The Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Portland Medical Center | |
Portland, Oregon, United States, 97205 |
Study Director: | Robin F Scamuffa, MS | Ethicon Endo-Surgery |
Study Director: | William Bernie, MD | Ethicon Endo-Surgery |
Principal Investigator: | Anthony J Senagore, MD | Medical University of Ohio |
Principal Investigator: | Anders F Mellgren, MD, PhD | University of Minnesota |
Responsible Party: | Ethicon Endo-Surgery ( Susan Knippenberg, Manager Clinical Affairs ) |
Study ID Numbers: | CI-05-0004 |
Study First Received: | November 18, 2005 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00256984 |
Health Authority: | United States: Institutional Review Board |
Obstructive Defecation Syndrome Colorectal Surgery Defecography Constipation |
Rectocele Intussusception Quality of Life |
Intestinal Obstruction Signs and Symptoms Rectocele Digestive System Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases |
Constipation Quality of Life Intussusception Intestinal Diseases Rectal Diseases |
Pathologic Processes Disease Syndrome |