Vaginal prolapse surgery : an epidemiological perspective : studies of native tissue repair versus implants, surgeons´ practical experiences and five year follow-up in the swedish national quality register for gynecological surgery

Abstract: Background: Pelvic organ prolapse (POP) is a common condition that impacts on quality of life for many women. The mean age of Swedish women operated for POP is 60 years, and with a life expectancy of approximately 84 years this means that the average patient will live 24 years subsequent to the operation. Therefore, sustainable long-term results of POP surgery are essential. In an effort to improve long-term outcomes of vaginal prolapse surgery, mesh materials have been developed for this purpose. In Sweden, synthetic mesh is used in 7.4% of all primary operations without any coherent consensus about their use. Prolapse surgery is regarded as a routine procedure performed at almost every hospital in Sweden, but a large proportion of the surgeons are inexperienced. In actuality, 73% of them perform the procedure once a month or less frequently. Simultaneously, surgery for POP has been reported to have a highfailure rate internationally. For most surgeons, the operation is a low-frequency procedure, and outcomes have been reported as unsatisfactory. The specific aims of these thesis were to examine:- Mesh-augmented repairs impact on operative results compared to nativetissue repair.- Surgical experience in performing a specific operation and utilize this knowledge in analysing how it may (or may not) affect operative results.- Long-term (5 year) national follow up of POP operations, regarding both the objective epidemiological data and the patient-reported outcomes.Methods: The studies in this thesis are based on data from the Swedish National Quality Register for Gynaecological Surgery (GynOp), which covers approximately 90% of all gynaecological operations in Sweden. The comparative follow-up of POP surgery using non-absorbable polypropylene mesh versus colporrhaphy using native tissue was analysed in two different cohorts, of women with a primary cystocele and women with a relapse after surgery for a rectocele. Both surgeon reported results and patient-reported outcomes (PROMs) were analysed 1 year post-surgery. Information about surgeons’ experience in performing POP operations was extracted from GynOp over 9 years. Inclusion criteria were otherwise healthy patients who underwent anterior or posterior native tissue repair, or both. The operations were divided into four groups according to the operative experience of the surgeon (measured as average number of operations per active year). Both PROM results and surgeon-reported outcomes after 1 year were investigated. For the long-term follow-up 5 years after any operation for a vaginal prolapse, a new questionnaire to capture PROM data was designed, validated and nationally distributed. Information about re-operations was extracted directly from GynOp.Results: Mesh-augmented repair of a primary cystocele had a significantly better outcome in terms of absence of symptoms, compared with native tissue repair, OR 1.53(95% CI 1.10-2.13), but also had more complications directly related to the procedure (OR 1.51, RD=6.6%). For recurrent rectocele, mesh was superior to native tissue repair, OR 2.06 (95% CI 1.03-4.35); the number of postoperative complications was equal in the two groups. Among the 1,092 surgeons who were active POP surgeons during the study, 803(73%) participated in POP operations once a month or less frequently in their active years. No differences in patient or surgeon-reported outcomes were seen between the “experience groups”. Kaplan-Meier curves for re-operation after a primary POP operation showed an overall retreatment rate of 11.2% after 5 years. The response rate for the patient questionnaire was 74.9%. Overall, 70% of the patients reported no symptoms, and around 72% and 82% were satisfied with the operative results and felt that their symptoms had improved, respectively.Discussion: Mesh use was, after 1 year of follow-up, generally characterized by a high cure rate and varying degrees of complications, such as postoperative pain. However, for recurrent rectocele, we found no immediate drawbacks of the method compared with native tissue repair, with the same high cure rate as seen in other compartments. Surgeon experience had no impact on the native tissue operation, and any inconsistency of outcome is more likely inherent in the method than attributable to a surgeon’s lack of experience.The 5-year results indicate that native tissue repair produces much better results, judging from overall Swedish results, than previously thought. This is backed up both by objective data indicating a minimal number of re-operations within 5 years for the most common cases (i.e. primary rectocele and cystocele) and by the outcomes reported by the patients themselves.Conclusions: Mesh-augmented repair is more effective than native tissue repair forrecurrent rectocele, and without increased risk of complications. Drawbacks of mesh repair vary for other compartments, and for primary operations.- Surgeons’ operative experience in routine POP operations using native tissue has no impact on outcome after 1 year.- Long-term results of POP repair with native tissue are excellent, with a low risk of re-operation and a persistent absence of subjective symptoms.