Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)

Study Overview
=================
Brief 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).

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.

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)

Conditions
-----------------
Rectocele, Intussusception, Obstructive Defecation Syndrome, Chronic Constipation

Intervention / Treatment
-----------------
* Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | Baseline, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Defecation Syndrome, Colorectal Surgery, Defecography, Constipation, Rectocele, Intussusception, Quality of Life