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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

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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.

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.

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Acknowledgement

The authors thank all participating surgeons who enrolled patients' data to the registry; Mrs. M. Bauer, coordinating study nurse, Regensburg; Dr. F. Daoud, Medalliance, for statistical evaluation and data management; and Dr. G. Ribaric, Ethicon Endo-Surgery Europe, for organization and support.

Conflict of interest (financial disclosure)

The prospective registry was run under the auspices of the “Deutsche Gesellschaft für Koloproktologie.” The German STARR registry was supported by a grant of Ethicon Endo-Surgery Europe. Ethicon Endo-Surgery Europe provided financial support to finance a study nurse (administrative work). There was no pressure or influence of Ethicon Endo-Surgery Europe on the scientific outcome of the registry.

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Authors and Affiliations

  1. Department of Surgery and Pelvic Floor Center, Caritas-Krankenhaus St. Josef, Landshuter Str. 65, 93053, Regensburg, Germany

    Oliver Schwandner & Alois Fürst

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  1. Oliver Schwandner
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on behalf of the German STARR Registry Study Group

Corresponding author

Correspondence to Oliver Schwandner.

Appendix German STARR registry study group

Appendix German STARR registry study group

Participating centers and collaborating surgeons are (in row of the number of patients included):

Waldkrankenhaus “Rudolf Elle,” Eisenberg (Dr. M. Fiedler, Dr. M. Hopp, Dr. G. Konrad);

Krankenhaus Dresden-Friedrichstadt, Dresden (Dr. S. Stelzner, Fr. Dr. K. Köhler, Dr. G. Hellmich);

Krankenhaus St. Hedwig, Berlin (Dr. J. Schmalfeldt, Dr. E. Lorenz);

Klinikum Mittleres Erzgebirge, Zschopau (Dr. H.-U. Dorn);

Oder-Spree-Krankenhaus, Beeskow (Dr. M. El-Din);

St. Barbara-Klinik, Hamm-Heesen (Dr. L. Sangueza, PD Dr. M. Krämer);

Westpfalz-Klinikum, Kirchheimbolanden (Dr. J. Heist);

Städtisches Klinikum Fulda (Dr. C. Bismarck, PD Dr. J. Hellinger);

Krankenhaus Waldfriede, Berlin (Dr. Th. Unglaube, Dr. R. Scherer);

Klinikum Ludwigsburg, Ludwigsburg (Dr. D. Weimann, Prof. Dr. Th. Schiedeck);

Caritas-Krankenhaus St. Josef, Regensburg (Prof. Dr. O. Schwandner, PD Dr. A. Fürst);

Mathias-Spital, Rheine (Dr. G. Reitemeyer, Prof. Dr. M. Lausen);

St. Martinus-Krankenhaus, Düsseldorf (Dr. U. Vogel, Dr. O. Bachmann, Dr. H. Grosch);

Klinikum Pirna, Pirna (Dr. J. Stiebitz);

Praxis für Koloproktologie, Kiel (Dr. J. Jongen, Dr. H. Peleikis);

Krankenhaus St. Elisabeth und St. Barbara, Halle (Dr. T. Plettner, Dr. W. Asperger);

Marien-Hospital, Erwitte (Dr. A. Peters);

Bethesda-Allgemeines Krankenhaus, Hamburg (PD Dr. S. Petersen, Prof. Dr. M. Sailer);

Schön-Kliniken, Neustadt i. Holstein (Dr. M. Konrad, Prof. Dr. H. Schimmelpenning);

Diakonissenkrankenhaus, Dresden (Dr. T. Jacobi);

Evangelisches Krankenhaus, Herne (Dr. R. Schmidt, Dr. M. Kemen);

Klinikum Essen-Mitte, Essen (Dr. A. Ommer);

DKD, Wiesbaden (Dr. A. Hofmeister);

Chirurgische Klinik Aschersleben-Staßfurt, Aschersleben-Staßfurt (Dr. Th. Landes);

Enddarmzentrum Mannheim, Mannheim (Prof. Dr. A. Herold);

Universitätsklinikum Lübeck, Lübeck (Dr. J. Nolde, Prof. Dr. H.-P. Bruch);

St. Anna-Virngrund-Klinik, Ellwangen (Dr. O. Mayer, Prof. Dr. B. Ultsch).

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Schwandner, O., Fürst, A. & on behalf of the German STARR Registry Study Group. Assessing the safety, effectiveness, and quality of life after the STARR procedure for obstructed defecation: results of the German STARR registry. Langenbecks Arch Surg 395, 505–513 (2010). https://doi.org/10.1007/s00423-009-0591-8

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