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

Ethicon

Status and phase

Completed

Phase 4

Conditions

Chronic Constipation

Obstructive Defecation Syndrome

Rectocele

Intussusception

Treatments

Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler

Study type

Interventional

Funder types

Industry

Identifiers

NCT00256984

CI-05-0004

Details and patient eligibility

About

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).

Full 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.

Enrollment

75 patients

Sex

Female

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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