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

This study has been completed.

Study NCT00256984 Information provided by Ethicon Endo-Surgery

First Received on November 18, 2005. Last Updated on March 7, 2011 History of Changes

Results First Received: October 27, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Obstructive Defecation Syndrome Chronic Constipation Rectocele Intussusception
Intervention:	Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Stapled Trans-Anal Rectal Resection (STARR)	STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler

Participant Flow: Overall Study

	Stapled Trans-Anal Rectal Resection (STARR)
STARTED	75
COMPLETED	59
NOT COMPLETED	16

Baseline Characteristics

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Reporting Groups

	Description
Stapled Trans-Anal Rectal Resection (STARR)	STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler

Baseline Measures

	Stapled Trans-Anal Rectal Resection (STARR)
Number of Participants [units: participants]	75
Age ^[1] [units: years] Median ( Full Range )	48 ( 23 to 80 )
Gender [units: participants]
Female	75
Male	0
ODS composite score ^[2] [units: units on a scale] Mean ± Standard Deviation	6.19 ± 3.13
number of subjects in each age range having STARR procedure [units: participants]
<=29 years	4
Between 30 and 39 years	9
Between 40 and 49 years	26
Between 50 and 59 years	18
Between 60 and 69 years	11
>=70 years	7

[1]	Median age at consent
[2]	Based upon Obstructed Defecation Syndrome (ODS) questionnaire. This questionnaire has eight questions, each dealing with frequency of a particular attribute associated with ODS (mechanical, difficulties to evacuate, digitation to evacuate, return to toilet to evacuate, feeling of incomplete evacuation, straining to evacuate, time needed to evacuate, and lifestyle alterations). Each is scored 0-3 (low to high on scale, no units. "0" is the lowest frequency of occurrence, "3" is the highest frequency of occurrence; the total of all attributes (0-24) is the final score.

[1]

Median age at consent

[2]

Based upon Obstructed Defecation Syndrome (ODS) questionnaire. This questionnaire has eight questions, each dealing with frequency of a particular attribute associated with ODS (mechanical, difficulties to evacuate, digitation to evacuate, return to toilet to evacuate, feeling of incomplete evacuation, straining to evacuate, time needed to evacuate, and lifestyle alterations). Each is scored 0-3 (low to high on scale, no units. "0" is the lowest frequency of occurrence, "3" is the highest frequency of occurrence; the total of all attributes (0-24) is the final score.

Outcome Measures

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1. Primary:

Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure [ Time Frame: one year from Baseline ]

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2. Secondary:

Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure [ Time Frame: Baseline, 1 month post procedure ]

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3. Secondary:

Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). [ Time Frame: Baseline, 6 months ]

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4. Secondary:

Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) [ Time Frame: Baseline, 6 months post procedure ]

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5. Secondary:

PAC QOL Patient Assessment of Constipation (Overall) [ Time Frame: Baseline, 12 months ]

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6. Secondary:

SF-12 QOL Change From Baseline (Physical Component)at 12 Months [ Time Frame: Baseline, 12 Months ]

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7. Secondary:

SF-12 QOL Change (Mental Component) at 12 Months From Baseline [ Time Frame: Baseline, 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Susan Knippenberg, Clinical Scientist
Organization: Ethicon Endo-Surgery
phone: 513 337-3452
e-mail: sknippen@its.jnj.com

Publications:

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

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.

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.

Siproudhis L, Dautreme 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.

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.

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

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.

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.

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.

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.

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. No abstract available.

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.

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.

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. No abstract available.

Jayne DG, Finan PJ. Stapled transanal rectal resection for obstructed defaecation and evidence-based practice. Br J Surg. 2005 Jul;92(7):793-4. No abstract available.

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.

Responsible Party:	Susan Knippenberg, Manager Clinical Affairs, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00256984 History of Changes
Other Study ID Numbers:	CI-05-0004
Study First Received:	November 18, 2005
Results First Received:	October 27, 2009
Last Updated:	March 7, 2011
Health Authority:	United States: Institutional Review Board