Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Condition: Obstructive Defecation Syndrome; Chronic Constipation; Rectocele; Intussusception
MeSH terms: Rectocele; Intussusception; Syndrome; Constipation
Intervention: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: Female
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Obstructive Defecation Syndrome; Colorectal Surgery; Defecography; Constipation; Rectocele; Intussusception; Quality of Life

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).
    

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