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Complications with alloplastic materials in pelvic floor reconstructive surgeries (Clinical applicability of the IUGA/ICS classification code)

  • The aim of this retrospective observational study is to describe and discuss various complications that can arise after insertion of alloplastic materials in the field of urogynecology that require further surgical interventions in order to manage them or to at least improve the quality of life in those women. We were able to collect data on 77 patients who fulfilled the criteria. Medical history, data of clinical findings, and outcomes were collected and analyzed. The most common complication seen as an indication for resecting slings or meshes was de novo overactive bladder syndrome (40%). Other indications seen were lower urinary tract obstruction or obstructive voiding symptoms (21%), chronic pain (21%), and de novo dyspareunia (13%). 36% of the patients had recurrent symptoms (failure) after insertion of alloplastic materials in the form of urinary incontinence or prolapse, 32% presented with vaginal erosions, 2 women had severe signs of infection with abscess formation, another 3 women had urogenital fistulae. Other rare complications after mesh or sling insertion are perforations of the urinary bladder or urethra. Proper case selection is the key factor. The use of meshes and slings seems justified only in patients with known connective tissue weakness and recurrences after native tissue repair. Otherwise, patients will be exposed to unnecessary risk without any expectable improvement to their quality of life. Most of the complications are mainly caused by wrong and inadequate surgical techniques, wrong indications, or missed diagnosis of the underlying problem. In addition, lack of long-term follow-up is usually the cause behind the negligence towards many complications. Therefore, only experienced physicians should be allowed to perform such procedures, and long-term postoperative follow-up is strongly recommended. As slings and meshes are used for procedures of choice as means to improve quality of life, and not for life threatening situations, there is a need for intensive informed consent. All possible alternatives have to be discussed, as do the pros and cons of selected procedures, even the rare complications. Mesh or sling resection is considered to be an effective solution for the management of such complications. It has shown a high success rate in comparison to conservative treatment, and the majority of patients were satisfied and experienced a big improvement in their quality of life. The most common complication after resection is the recurrence of primary symptoms, either urinary incontinence or prolapse. Major or serious intra- or postoperative complications are very rare. All complications were classified and given a code according to the classification system of the international urogynecological association and the international continence society (IUGA/ICS) on 2011. The applicability and practicability of this code were evaluated, looking for ways to possibly improve it or to identify missing parameters. Many patients had more than one code, a problem that entirely torpedoed the idea of “simple” classification. Some complications are not covered individually in the classification, such as failure and recurrence or overactive bladder syndrome. These complications should be included. Many cases began with the same code, despite having different complications. Further sub-classifications should be considered to enable the reader to easily recognize the complication at hand. Patients who came with complications more than one year after mesh or sling insertion were categorized as (T4), regardless of whether the complication arose after 1 year of after 10. Therefore, sub-classifications in the (T4) category are recommended. The “site” category was not applicable in many cases. Furthermore, it is necessary that the severity of a complication is discernible, and should be mentioned in the code. We did not find any correlation between the code given and patient satisfaction. After re-modification and completion, the IUGA/ICS code could be more practical for clinical use, which would allow for the comparison of complications and make the assessment of adverse effects easier for research purposes.
  • Das Ziel dieser Arbeit war es, die Komplikationen nach Implantation von alloplastischen Materialien im Beckenboden zu erfassen, die eine Revisions-Operation erfordern. Es wurde die internationale Klassifikation der „International Urogynecological Association & International Continence Society“ auf ihre Praktikabilität überprüft. Retrospektiv wurden die Zuweisungen in die Universitäts – Frauenklinik Greifswald von 2011 bis 2014 erfasst, bei 77 Patientinnen mussten Komplikationen operativ korrigiert werden. Anamnese, klinische Befunde sowie OP-Berichte wurden dafür bearbeitet und ausgewertet. 52 % der Patientinnen stellten sich mit mehreren Komlikationen und unterschiedlichen Beschwerden vor. Die häufigsten Indikationen für eine Resektion von Band/Netz waren Symptome einer de novo überactiven Blase sowie einer mechanischen Obstruktion. Andere Indikationen waren chronische Schmerzen, de novo Dyspareunie, urogenitale Infektionen, Fistelbildungen und Perforationen der Harnblase. 36% der Patientinnen gaben zusätzlich Rezidive und Senkungsbeschwerden an. Entsprechend der Analyse unserer Daten sind die meisten Komplikationen durch falsche Operationstechnik, z.T. falsche Indikation und Selektion bedingt. Alle von uns erfassten Komplikationen wurden nach IUGA und ICS Kriterien klassifiziert. Es wurde nach Lücken und Verbesserungsmöglichkeiten gesucht. Trotz unterschiedlicher Komplikationen und Zeitintervalle erfuhren viele Fälle die gleiche Kodierung. Viele Patienten hatten mehr als einen Code, welches dem Ziel der "einfachen" Einstufung widerspricht. Einige Komplikationen sind nicht in der Klassifikation vorgesehen. Modifikationen und weitere Sub-Klassifikationen sollten erwogen werden. Die Verwendung von alloplastischen Materialien ist nur bei Patienten mit ausgeprägter Bindegewebsschwäche und Rezidiv nach nativer Gewebereparatur indiziert, nur erfahrene Ärzte sollten solche Eingriffe durchführen und ihre Indikation stellen. Konservative Behandlungsstrategien nach Auftritt einer Komplikation haben nur geringe Heilungschance und eine operative Revision sollte in Betracht gezogen werden. Ein long-term Follow-up ist zu empfehlen, da Komplikationen noch nach Jahren auftreten können.

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Metadaten
Author: Zaher Alwafai
URN:urn:nbn:de:gbv:9-002650-0
Title Additional (German):Komplikationen nach rekonstruktiven Eingriffen am Beckenbodens mit alloplastischen Materialien (Die klinische Anwendbarkeit der IUGA/ICS Klassifikation)
Advisor:Prof. Dr. Marek Zygmunt
Document Type:Doctoral Thesis
Language:English
Date of Publication (online):2016/11/01
Granting Institution:Ernst-Moritz-Arndt-Universität, Universitätsmedizin (bis 31.05.2018)
Date of final exam:2016/10/11
Release Date:2016/11/01
GND Keyword:Band, Beckenboden, Netz, Schlinge, alloplastische Materialien
Faculties:Universitätsmedizin / Klinik und Poliklinik für Frauenheilkunde u. Geburtshilfe
DDC class:600 Technik, Medizin, angewandte Wissenschaften / 610 Medizin und Gesundheit