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

NCT00256984 | Completed Phase 4 Results

• 1 other identifier: CI-05-0004
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

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).

Conditions

Obstructive Defecation Syndrome; Chronic Constipation; Rectocele; Intussusception

Keywords

Obstructive Defecation Syndrome; Colorectal Surgery; Defecography; Constipation; Rectocele; Intussusception; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure

  Baseline, 1 month post procedure

• Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).

  Baseline, 6 months

• Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)

  Baseline, 6 months post procedure

• PAC QOL Patient Assessment of Constipation (Overall)

  Baseline, 12 months

• SF-12 QOL Change From Baseline (Physical Component)at 12 Months

  Baseline, 12 Months

Interventions

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

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (7)

Colon and Rectal Clinic of Orlando

Orlando, Florida, 32806, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Colon & Rectal Surgery Associates Ltd.

Minneapolis, Minnesota, 55454, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Medical University of Ohio, Department of Surgery

Toledo, Ohio, 43614, United States

Location

Portland Medical Center

Portland, Oregon, 97205, United States

Location

Related Publications (16)

• Shorvon PJ, McHugh S, Diamant NE, Somers S, Stevenson GW. Defecography in normal volunteers: results and implications. Gut. 1989 Dec;30(12):1737-49. doi: 10.1136/gut.30.12.1737.

  PMID: 2612988 BACKGROUND

• 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. doi: 10.1007/pl00004019.

  PMID: 10384970 BACKGROUND

• 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. doi: 10.1016/0016-5085(93)90896-k.

  PMID: 8359649 BACKGROUND

• 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.

  PMID: 7552638 BACKGROUND

• 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. doi: 10.1007/BF02236738.

  PMID: 11089592 BACKGROUND

• Fleshman JW, Fry RD, Kodner IJ. The surgical management of constipation. Baillieres Clin Gastroenterol. 1992 Mar;6(1):145-62. doi: 10.1016/0950-3528(92)90024-9.

  PMID: 1586766 BACKGROUND

• 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. doi: 10.1007/s10350-004-6465-9.

  PMID: 12432306 BACKGROUND

• 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. doi: 10.1007/s10151-003-0026-4.

  PMID: 14628157 BACKGROUND

• 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. doi: 10.1007/s10350-004-0582-3.

  PMID: 15484341 BACKGROUND

• 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. doi: 10.1007/s00384-003-0572-2. Epub 2004 Mar 13.

  PMID: 15024596 BACKGROUND

• 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. doi: 10.1007/s00384-004-0658-5. Epub 2004 Sep 2. No abstract available.

  PMID: 15349740 BACKGROUND

• 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.

  PMID: 15741014 BACKGROUND

• 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.

  PMID: 16035252 BACKGROUND

• 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. doi: 10.1007/s10350-005-0103-z. No abstract available.

  PMID: 15991070 BACKGROUND

• Jayne DG, Finan PJ. Stapled transanal rectal resection for obstructed defaecation and evidence-based practice. Br J Surg. 2005 Jul;92(7):793-4. doi: 10.1002/bjs.5092. No abstract available.

  PMID: 15962257 BACKGROUND

• 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. doi: 10.1016/s0025-6196(12)62169-7.

  PMID: 2232900 BACKGROUND

MeSH Terms

Conditions

Rectocele; Intussusception; Constipation

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Signs and Symptoms, Digestive; Signs and Symptoms

Results Point of Contact

• Title: Susan Knippenberg, Clinical Scientist
• Organization: Ethicon Endo-Surgery

sknippen@its.jnj.com

513 337-3452

Study Officials

• Robin F Scamuffa, MS

  Ethicon Endo-Surgery

  STUDY DIRECTOR

• William Bernie, MD

  Ethicon Endo-Surgery

  STUDY DIRECTOR

• Anthony J Senagore, MD

  Medical University of Ohio

  PRINCIPAL INVESTIGATOR

• Anders F Mellgren, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 16, 2018
• Results First Posted: April 7, 2011

Record last verified: 2017-10

Locations

US (7)