Clinical trial NCT00256984: Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Official title: A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Defecation Syndrome
Chronic Constipation
Rectocele
Intussusception
Keywords: Obstructive Defecation Syndrome
Colorectal Surgery
Defecography
Constipation
Rectocele
Intussusception
Quality of Life
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure
timeFrame: one year from Baseline
Secondary outcomes:
measure: Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure
timeFrame: Baseline, 1 month post procedure
measure: Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).
timeFrame: Baseline, 6 months
measure: Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)
timeFrame: Baseline, 6 months post procedure
measure: PAC QOL Patient Assessment of Constipation (Overall)
timeFrame: Baseline, 12 months
measure: SF-12 QOL Change From Baseline (Physical Component)at 12 Months
timeFrame: Baseline, 12 Months
measure: SF-12 QOL Change (Mental Component) at 12 Months From Baseline
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Colon and Rectal Clinic of Orlando
state: Florida
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Minneapolis
country: United States
facility: Colon & Rectal Surgery Associates Ltd.
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio, Department of Surgery
state: Ohio
city: Portland
country: United States
facility: Portland Medical Center
state: Oregon
Study officials:
affiliation: Ethicon Endo-Surgery
name: Robin F Scamuffa, MS
role: STUDY_DIRECTOR
affiliation: Ethicon Endo-Surgery
name: William Bernie, MD
role: STUDY_DIRECTOR
affiliation: Medical University of Ohio
name: Anthony J Senagore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Anders F Mellgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Grassi R, Romano S, Micera O, Fioroni C, Boller B. Radiographic findings of post-operative double stapled trans anal rectal resection (STARR) in patient with obstructed defecation syndrome (ODS). Eur J Radiol. 2005 Mar;53(3):410-6. doi: 10.1016/j.ejrad.2004.12.012.
citation: Mongardini M, Custureri F, Schillaci F, Cola A, Maturo A, Fanello G, Corelli S, Pappalardo G. [Prevention of post-operative pain and haemorrhage in PPH (Procedure for Prolapse and Hemorrhoids) and STARR (Stapled Trans-Anal Rectal Resection). Preliminary results in 261 cases]. G Chir. 2005 Apr;26(4):157-61. Italian.
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