Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation
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Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation : results of the German STARR registry. / German STARR Registry Study Group.
In: LANGENBECK ARCH SURG, Vol. 395, No. 5, 06.2010, p. 505-13.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation
T2 - results of the German STARR registry
AU - Schwandner, Oliver
AU - Fürst, Alois
AU - German STARR Registry Study Group
PY - 2010/6
Y1 - 2010/6
N2 - 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.CONCLUSION: 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.
AB - 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.CONCLUSION: 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.
KW - Chi-Square Distribution
KW - Constipation/etiology
KW - Defecation/physiology
KW - Female
KW - Germany/epidemiology
KW - Humans
KW - Intestinal Obstruction/etiology
KW - Male
KW - Middle Aged
KW - Patient Selection
KW - Postoperative Complications/epidemiology
KW - Prospective Studies
KW - Quality of Life
KW - Rectal Prolapse/complications
KW - Rectocele/complications
KW - Registries
KW - Severity of Illness Index
KW - Treatment Outcome
U2 - 10.1007/s00423-009-0591-8
DO - 10.1007/s00423-009-0591-8
M3 - SCORING: Journal article
C2 - 20549229
VL - 395
SP - 505
EP - 513
JO - LANGENBECK ARCH SURG
JF - LANGENBECK ARCH SURG
SN - 1435-2443
IS - 5
ER -