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

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.

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