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

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