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

Chronic Constipation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256984
• Other study ID #: CI-05-0004
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2005
• Est. completion date: June 1, 2008

Study information

• Verified date: October 2017
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2008
• Est. primary completion date: March 1, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Intussusception
• Obstructive Defecation Syndrome
• Rectocele
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Colon & Rectal Surgery Associates Ltd.	Minneapolis	Minnesota
United States	Colon and Rectal Clinic of Orlando	Orlando	Florida
United States	Portland Medical Center	Portland	Oregon
United States	Medical University of Ohio, Department of Surgery	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

References & Publications (16)

Altomare DF, Rinaldi M, Veglia A, Petrolino M, De Fazio M, Sallustio P. Combined perineal and endorectal repair of rectocele by circular stapler: a novel surgical technique. Dis Colon Rectum. 2002 Nov;45(11):1549-52. — View Citation

Binda GA, Pescatori M, Romano G. The dark side of double-stapled transanal rectal resection. Dis Colon Rectum. 2005 Sep;48(9):1830-1; author reply 1831-2. — View Citation

Boccasanta P, Venturi M, Salamina G, Cesana BM, Bernasconi F, Roviaro G. New trends in the surgical treatment of outlet obstruction: clinical and functional results of two novel transanal stapled techniques from a randomised controlled trial. Int J Colorectal Dis. 2004 Jul;19(4):359-69. Epub 2004 Mar 13. — View Citation

Boccasanta P, Venturi M, Stuto A, Bottini C, Caviglia A, Carriero A, Mascagni D, Mauri R, Sofo L, Landolfi V. Stapled transanal rectal resection for outlet obstruction: a prospective, multicenter trial. Dis Colon Rectum. 2004 Aug;47(8):1285-96; discussion 1296-7. — View Citation

Dodi G, Pietroletti R, Milito G, Binda G, Pescatori M. Bleeding, incontinence, pain and constipation after STARR transanal double stapling rectotomy for obstructed defecation. Tech Coloproctol. 2003 Oct;7(3):148-53. — View Citation

Fleshman JW, Fry RD, Kodner IJ. The surgical management of constipation. Baillieres Clin Gastroenterol. 1992 Mar;6(1):145-62. Review. — View 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. — View Citation

Jayne DG, Finan PJ. Stapled transanal rectal resection for obstructed defaecation and evidence-based practice. Br J Surg. 2005 Jul;92(7):793-4. — View Citation

Kenton K, Shott S, Brubaker L. The anatomic and functional variability of rectoceles in women. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10(2):96-9. — View 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. — View Citation

Pescatori M, Dodi G, Salafia C, Zbar AP. Rectovaginal fistula after double-stapled transanal rectotomy (STARR) for obstructed defaecation. Int J Colorectal Dis. 2005 Jan;20(1):83-5. Epub 2004 Sep 2. — View Citation

Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989 Dec;30(12):1737-49. — View Citation

Siproudhis L, Dautrème S, Ropert A, Briand H, Renet C, Beusnel C, Juguet F, Rabot AF, Bretagne JF, Gosselin M. Anismus and biofeedback: who benefits? Eur J Gastroenterol Hepatol. 1995 Jun;7(6):547-52. — View Citation

Talley NJ, Phillips SF, Wiltgen CM, Zinsmeister AR, Melton LJ 3rd. Assessment of functional gastrointestinal disease: the bowel disease questionnaire. Mayo Clin Proc. 1990 Nov;65(11):1456-79. — View Citation

Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Functional constipation and outlet delay: a population-based study. Gastroenterology. 1993 Sep;105(3):781-90. — View Citation

van Dam JH, Hop WC, Schouten WR. Analysis of patients with poor outcome of rectocele repair. Dis Colon Rectum. 2000 Nov;43(11):1556-60. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure	The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.	one year from Baseline
Secondary	Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure	Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.	Baseline, 1 month post procedure
Secondary	Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).	Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.	Baseline, 6 months
Secondary	Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)	The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.	Baseline, 6 months post procedure
Secondary	PAC QOL Patient Assessment of Constipation (Overall)	PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol	Baseline, 12 months
Secondary	SF-12 QOL Change From Baseline (Physical Component)at 12 Months	The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.	Baseline, 12 Months
Secondary	SF-12 QOL Change (Mental Component) at 12 Months From Baseline	SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.	Baseline, 12 months