title: Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation: results of the German STARR registry.
abstract: BACKGROUND
  Internal rectal prolapse and rectocele are frequent clinical findings in patients with obstructed defecation syndrome (ODS). However, there is still no evidence whether stapled transanal rectal resection (STARR) provides a safe and effective surgical option. Therefore, the German STARR registry was initiated to assess safety, effectiveness, and quality of life.
  
  
  METHODS
  The German STARR registry was designed as an interventional, prospective, multicenter audit. Primary outcomes include safety (morbidity and adverse events), effectiveness (ODS, symptom severity, and incontinence scores), and quality of life (PAC-QoL and EQ-5D) documented at baseline and at 6 and 12 months. Statistical evaluation was performed by an independent research organization of clinical epidemiology.
  
  
  RESULTS
  Complete data of 379 patients (78% females, mean age 57.8 years) were entered into the registry database. Mean operative time was 40 min, mean hospitalization was 5.5 days. A total of 103 complications and adverse events were reported in 80 patients (21.1%) including staple line complications (minor bleeding, infection, or partial dehiscence; 7.1%), major bleeding (2.9%), and postsurgical stenosis (2.1%). Comparisons of ODS and symptom severity scores (SSS) demonstrated a significant reduction in ODS score between baseline (mean 11.14) and 6 months (mean 6.43), which was maintained at 12 months (mean 6.45), and SSS at preoperative and at 6- and 12-month follow-up (13.02 vs. 7.34 vs. 6.59; paired t test, p < 0.001). Significant reduction in ODS symptoms was matched by an improvement in quality of life as judged by symptom-specific PAC-QoL and generic ED-5Q (utility and visual analog scale) scores and was not associated with an impairment of incontinence score following STARR (p > 0.05). However, 11 patients (2.9%) showed de novo incontinence, and new-onset symptoms of fecal urgency were observed in 25.3% of patients.
  
  
  CONCLUSIONS
  These data indicate that STARR is a safe and effective procedure. However, conclusions are limited due to the selection and reporting bias of a registry. The problem of fecal urgency needs cautious reassessment.
authors.affiliation: Department of Surgery and Pelvic Floor Center, Caritas-Krankenhaus St. Josef, Landshuter Str. 65, 93053, Regensburg, Germany. oschwandner@caritasstjosef.de
authors.forename: Oliver
authors.initials: O
authors.lastname: Schwandner
authors.forename: Alois
authors.initials: A
authors.lastname: Fürst
mesh_terms: D016009:Chi-Square Distribution; D003248:Constipation / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D003672:Defecation / Q000502:physiology*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D012005:Rectal Prolapse / Q000150:complications / Q000503:physiopathology / Q000601:surgery; D020047:Rectocele / Q000150:complications / Q000503:physiopathology / Q000601:surgery; D012042:Registries; D012720:Severity of Illness Index; D016896:Treatment Outcome