Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
|Obstructive Defecation Syndrome Chronic Constipation Rectocele Intussusception||Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- 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.
- Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure [ Time Frame: Baseline, 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.
- Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). [ Time Frame: Baseline, 6 months ]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 ]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 ]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 ]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 ]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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256984
|United States, Florida|
|Colon and Rectal Clinic of Orlando|
|Orlando, Florida, United States, 32806|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|United States, Minnesota|
|Colon & Rectal Surgery Associates Ltd.|
|Minneapolis, Minnesota, United States, 55454|
|United States, Ohio|
|University Hospitals of Cleveland|
|Cleveland, Ohio, United States, 44106|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Medical University of Ohio, Department of Surgery|
|Toledo, Ohio, United States, 43614|
|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 - Clinical and Translational Science Institute|