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



Status:Completed
Conditions:Constipation, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - 80
Updated:7/18/2018
Start Date:October 1, 2005
End Date:June 1, 2008

Use our guide to learn which trials are right for you!

A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)

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).

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
We found this trial at
7
sites
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
?
mi
from
Burlington, MA
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Portland, Oregon 97205
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials