| 1. |
- Nüssler, Emil, et al.
(author)
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Impact of surgeon experience on routine prolapse operations
- 2018
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In: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 29:2, s. 297-306
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Journal article (peer-reviewed)abstract
- Introduction and hypothesis: Surgical work encompasses important aspects of personal and manual skills. In major surgery, there is a positive correlation between surgical experience and results. For pelvic organ prolapse (POP), this relationship has to our knowledge never been examined. In any clinical practice, there is always a certain proportion of inexperienced surgeons. In Sweden, most prolapse surgeons have little experience in performing prolapse operations, 74% conducting the procedure once a month or less. Simultaneously, surgery for POP globally has failure rates of 25-30%. In other words, for most surgeons, the operation is a low-frequency procedure, and outcomes are unsatisfactory. The aim of this study was to clarify the acceptability of having a high proportion of low-volume surgeons in the management of POP.Methods: A group of 14,676 exclusively primary anterior or posterior repair patients was assessed. Data were analyzed by logistic regression and as a group analysis.Results: Experienced surgeons had shorter operation times and hospital stays. Surgical experience did not affect surgical or patient-reported complication rates, organ damage, reoperation, rehospitalization, or patient satisfaction, nor did it improve patient-reported failure rates 1 year after surgery. Assistant experience, similarly, had no effect on the outcome of the operation.Conclusions: A management model for isolated anterior or posterior POP surgery that includes a high proportion of low-volume surgeons does not have a negative impact on the quality or outcome of anterior or posterior colporrhaphy. Consequently, the high recurrence rate was not due to insufficient experience of the surgeons performing the operation.
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| 2. |
- Nüssler, Emil Karl, et al.
(author)
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Decisions to use surgical mesh in operations for pelvic organ prolapse : a question of geography?
- 2019
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In: International Urogynecology Journal. - : Springer London. - 0937-3462 .- 1433-3023. ; 30:9, s. 1533-1539
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Journal article (peer-reviewed)abstract
- Introduction and hypothesis: Surgical mesh can reinforce damaged biological structures in operations for genital organ prolapse. When a method is new, scientific information is often contradictory. Individual surgeons may accept different observations as useful, resulting in conflicting treatment strategies. Additional scientific information should lead to increasing convergence.Methods: Based on data from the Swedish National Quality Register of Gynecological Surgery, all patients who underwent their first recurrent anterior compartment prolapse operation between 2006 and 2017 were included (2758 patients). Surgical mesh was used in 56.5%. We analyzed inter-county disparities in and patterns of mesh use over 12 years. To minimize confounding, we selected a group of highly comparable patients where similar decision patterns could be expected.Results: The use of mesh differed between counties by a factor of 11 (8.6-95.3%). Counties with low use of mesh continued with low use and counties with high use continued with high use.Conclusions: Decisions regarding how to interpret existing scientific information about mesh implants in the early years of mesh use have led to "communities of practice" highly influenced by geographical factors. For 12 years, these groups have made disparate decisions and upheld them without measurable change toward consensus. The scientific learning process has stopped-despite the abundance of new publications and the steady supply of new types of mesh. Ongoing disparity in surgeons' choices in comparable patients has an adverse effect on clinical care. For the patient, this represents 12 years of a geographical lottery concerning whether mesh is used or not.
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| 3. |
- Nüssler, Emil, et al.
(author)
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Operation for primary cystocele with anterior colporrhaphy or non-absorbable mesh : patient-reported outcomes
- 2015
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 26:3, s. 359-366
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Journal article (peer-reviewed)abstract
- The aim of this study was to compare the results of primary anterior vaginal wall prolapse repair, using standard anterior colporrhaphy or non-absorbable mesh in a routine health care setting. The study was based on prospectively collected data from the Swedish National Register for Gynaecological Surgery. All patients were operated on solely for primary, anterior vaginal wall prolapse between January 2006 and October 2013: 6,247 women had an anterior colporrhaphy, and in 356 a non-absorbable mesh was used. Data were collected from doctors and patients up to 1 year after surgery. The 1-year cure rate for the mesh group was superior to that of the colporrhaphy group with an odds ratio (OR) of 1.53 (CI 1.1-2.13), corresponding to a number needed to treat (NNT) of 13.5. Patient satisfaction, OR = 2.45 (CI 1.58-3.80), and patient improvement, OR 2.99 (CI 1.62-5.54), was also higher in the mesh group. However, patient-reported complications, OR = 1.51 (CI 1.15-1.98), and the incidence of persisting pain in the loin, OR = 3.58 (CI 2.32-5.52), were also higher in the mesh group as were surgeon-reported complications, OR = 2.27 (CI 1.77-2.91), bladder injuries, OR = 6.71 (CI 3.14-14.33), and re-operations within 12 months, OR = 6.87 (CI 3.68-12.80). Mesh reinforcement, in primary anterior vaginal wall prolapse patients, enhanced the likelihood of anatomical success at 1 year after surgery. However, mesh implant was associated with a significantly higher incidence of bladder injury, reoperations, both patient- and surgeon-reported complications, more patient-reported pain and a longer hospital stay.
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| 4. |
- Nüssler, Emil, et al.
(author)
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Repair of recurrent rectocele with posterior colporrhaphy or non-absorbable polypropylene mesh : patient-reported outcomes at 1-year follow-up.
- 2019
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 30:10, s. 1679-1687
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Journal article (peer-reviewed)abstract
- INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of repair of isolated, recurrent, posterior vaginal wall prolapse using standard posterior colporrhaphy versus non-absorbable polypropylene mesh in a routine health care setting.METHODS: This cohort study was based on prospectively collected data from the Swedish National Register for Gynaecological Surgery. All patients operated for recurrent, posterior vaginal wall prolapse in Sweden between 1 January 2006 and 30 October 2016 were included. A total of 433 women underwent posterior colporrhaphy, and 193 were operated using non-absorbable mesh. Data up to 1 year were collected.RESULTS: The 1-year patient-reported cure rate was higher for the mesh group compared with the colporrhaphy group, with an odds ratio (OR) of 2.06 [95% confidence interval (CI) 1.03-4.35], corresponding to a number needed to treat of 9.7. Patient satisfaction (OR = 2.38; CI 1.2-4.97) and improvement (OR = 2.13; CI 1.02-3.82) were higher in the mesh group. However, minor surgeon-reported complications were more frequent with mesh (OR = 2.74; CI 1.51-5.01). Patient-reported complications and re-operations within 12 months were comparable in the two groups.CONCLUSIONS: For patients with isolated rectocele relapse, mesh reinforcement enhances the likelihood of success compared with colporrhaphy at 1-year follow-up. Also, in our study, mesh repair was associated with greater patient satisfaction and improvement of symptoms, but an increase in minor complications. Our study indicates that the benefits of mesh reinforcement may outweigh the risks of this procedure for women with isolated recurrent posterior prolapse.
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| 5. |
- Nüssler, Emil Karl, et al.
(author)
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Operation for recurrent cystocele with anterior colporrhaphy or non-absorbable mesh : patient reported outcomes
- 2013
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In: International Urogynecology Journal. - : Springer London. - 0937-3462 .- 1433-3023. ; 24:11, s. 1925-1931
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Journal article (peer-reviewed)abstract
- Introduction and hypothesis: The aim of this study was to compare patient reported outcomes and complications after repair of recurrent anterior vaginal wall prolapse in routine health care settings using standard anterior colporrhaphy or non-absorbable mesh.Methods: The study is based on prospective data from the Swedish National Register for Gynaecological Surgery. 286 women were operated on for recurrent anterior vaginal wall prolapse in 2008–2010; 157 women had an anterior colporrhaphy and 129 were operated on with a non-absorbable mesh. Pre-, and perioperative data were collected from doctors and patients. Patient reported outcomes were evaluated 2 months and 12 months after the operation.Results: After 12 months, the odds ratio (OR) of patient reported cure was 2.90 (1.34–6.31) after mesh implants compared with anterior colporrhaphy. Both patient- and doctor-reported complications were found more often in the mesh group. However, no differences in serious complications were found. Thus, an organ lesion was found in 2.3 % after mesh implant compared with 2.5 % after anterior colporrhaphy (p = 0.58). Two patients in the mesh group (1.2 %) were re-operated compared with 1 patient (0.6 %) in the anterior colporrhaphy group (p = 0.58). The infection rate was higher after mesh (8.5 %) than after anterior colporrhaphy (2.5 %; OR 3.19 ; 1.07–14.25).Conclusion: Implantation of synthetic mesh during operation for recurrent cystocele more than doubled the cure rate, whereas no differences in serious complications were found between the groups. However, mesh increased the risk of infection.
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| 6. |
- Madsen, Lene Duch, et al.
(author)
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Native-tissue repair of isolated primary rectocele compared with nonabsorbable mesh : patient-reported outcomes
- 2017
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In: International Urogynecology Journal. - : Springer Science and Business Media LLC. - 0937-3462 .- 1433-3023. ; 28:1, s. 49-57
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Journal article (peer-reviewed)abstract
- We evaluated patient-reported outcomes and complications after treatment of isolated primary rectocele in routine health-care settings using native-tissue repair or nonabsorbable mesh. We used prospective data from the Swedish National Register for Gynaecological Surgery and included 3988 women with a primary operation for rectocele between 2006 and 2014: 3908 women had native-tissue repair, 80 were operated with nonabsorbable mesh. No concurrent operations were performed. Pre- and perioperative data were collected from doctors and patients. Patient-reported outcomes were evaluated 2 and 12 months after the operation. Only validated questionnaires were used. One year after native-tissue repair, 77.8 % (76.4-79.6) felt they were cured, which was defined as never or hardly ever feeling genital protrusion; 74.0 % (72.2-75.7) were very satisfied or satisfied, and 84 % (82.8-85.9) reported improvement of symptoms. After mesh repair, 89.8 % (77.8-96.6) felt cured, 69.2 % (54.9-81.3) were very satisfied or satisfied, and 86.0 % (72.1-94.7) felt improvement. No significant differences were found between groups. Organ damage was found in 16 (0.4 %) patients in the native-tissue repair group compared with one (1.3 %) patient in the mesh group [odds ratio (OR) 3.08; 95 % confidence interval (CI) 0.07-20.30]. The rate of de novo dyspareunia after native-tissue repair was 33.1 % (30.4-35.8), comparable with that after mesh repair. The reoperation rate was 1.1 % (0.8-1.5) in both groups. Most patients were cured and satisfied after native-tissue repair of the posterior vaginal wall, and the patient-reported outcomes were comparable with results after mesh repair. The risk of serious complications and reoperation were comparable between groups.
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| 7. |
- Nüssler, Emil Karl
(author)
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Surgical quality control of minimally invasive procedures, fast-track surgery and implant technology in gynaecological surgery in Sweden
- 2019
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Licentiate thesis (other academic/artistic)abstract
- Internationally as well as in Sweden, efforts for improvement in gynaecological surgery in recent decades have mainly focused on three new treatment concepts:(1) Use of minimally invasive procedures: since there is an interdependency between the extent of surgical trauma and the risk for adverse outcome, increased use of supposedly atraumatic endoscopic procedures has revolutionized several aspects of surgical care(2) A multimodal approach to eliminate harmful procedures in the peri-operative process based on evidence-based principles(3) Introduction of implants to support damaged tissue with synthetic mesh in incontinence and pelvic organ prolapse patients.Research question 1: Is introduction of a minimally invasive operation enough per se or is the measured improvement mediated by elimination of harmful procedures in the perioperative process?Findings: Our study (Paper I) indicates that by applying a multimodal intervention programme for the pre- and postoperative care of patients undergoing supravaginal hysterectomy, the surgical procedure per se is of less importance than generally considered. Patient-related parameters such as length of postoperative hospital stay, number of days at home with need of painkillers, number of days before return to normal activities, and patient satisfaction did not differ between patients undergoing the laparoscopic procedure and patients undergoing abdominal supravaginal hysterectomy. When evaluating a new and presumably improved operative procedure against an established standard procedure, it is mandatory and of fundamental importance that the two methods are aligned in terms of perioperative care provided.Research question 2: Under which circumstances can it be assumed that a new surgical procedure showing promising efficacy in one setting can be reproduced with similar results in a different clinical setting (Paper I)?Findings: The operating surgeons concluded that, in their hands and under local conditions, laparoscopic technique for supravaginal hysterectomy was not superior to traditional open hysterectomy and stopped using laparoscopic technique. It seems necessary, prior to routine use, to monitor, using scientific tools, whether the advantages described in the literature are achievable under local conditions.Research question 3: Do expected advantages of implants outweigh the unwanted effects and complications caused by implants in operations for recurrent cystocele (Paper II)?Findings: Mesh has better durability but more (minor) complications. It is not possible to determine whether mesh is "generally better" than native tissue operation. Some may focus on the improved durability, others on the increased risks. The surgeon must make a risk assessment for each individual case. The patient must be sufficiently informed to understand the risks and make a personal, informed decision whether she wants an augmentation by implant. Essential for this process is a clear, comprehensible picture of both desired and unwanted effects of the planned surgery. In this context, studies like ours might be of use.
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