STARR PROCEDURE FOR OBSTRUCTED DEFAECATION SYNDROME (ODS)- 12-MONTH FOLLOW-UP

Author(s)

Goran Ribaric, MD, Health Outcome Manager1, David R Jayne, BSc, MB, BCh, MD, Senior Lecturer & Consultant Surgeon2, Angelo Stuto, MD, Surgeon3, Oliver Schwandner, MD, Surgeon4, Luca Morlotti, MSc, Senior Health Outcome Manager11Ethicon Endo Surgery, Norderstedt, Germany; 2 St. James's University Hospital, Leeds, United Kingdom; 3 Ospedale Santa Maria degli Angeli, Pordenone, Italy; 4 Caritas-Krankenhaus St. Josef, Regensburg, Germany

Objective: A European STARR registry was set-up to determine the short-term safety and effectiveness of the STARR procedure for obstructed defaecation syndrome. Methods: STARR registries in Italy, Germany and the UK were designed with a web-based interface to allow pooling of results for combined analysis. Recruitment commenced in January 2006. Data collection included a symptom severity score (SSS), obstructed defaecation score (ODS), Cleveland clinic incontinence score, symptom-specific (PAC-QoL) and generic (ED-5Q utility and VAS) QoL score. All complications were recorded. Data collection was performed at baseline, 6 weeks, and 6 and 12 months. Results: A total of 1456 patients were recruited and eligible for analysis. There were 214 (14.7%) male patients. The mean age was 54 yrs (range: 17-92). Mean operative time was 44mins (range: 15-210). Average length of stay was 3 days (range:1-36). By September 2007, 698 (48%) and 422 (29%) were eligible for analysis at 6 and 12 months. respectively. A significant symptomatic improvement was seen between baseline and 6 months and maintained at 12 months (SSS: baseline 24.1 (95%CI: 23.8,24.4) v's 12 months 12.5 (95%CI: 12.1,12.9), p<0.001; ODS: baseline 15.3 (95%CI: 14.9,15.6) v's 12 months 5.8 (95%CI: 4.8,6.7), p<0.001. This was reflected in a significant improvement in both PAC-QoL and ED-5Q QoL scores at both 6 and 12 months. Incontinence scores improved from 3.1 (95%CI: 2.9,3.3) at baseline to 2.9 (95%CI: 2.1,2.7) at 6 months and 1.9 (95%CI: 1.5,2.2) at 12 months (p<0.001). 457 minor and major complications were reported, of which the most frequent were: unexpected pain (7.7%), urinary retention (6.8%), bleeding (4.5%), stapled line complications (3.2%), sepsis (1.4%), incontinence (1.3%). Postoperative defaecatory urgency was reported in 17% of patients. There was no mortality. Conclusion: STARR for ODS is safe,effective and significant improvement in QoL.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PHC12

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Surgery

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