The aim of this study is to determine how complications can be avoided in gynecological minimally invasive surgery in Europe. The Norwegian Gynecological Endoscopic Registry (NGER) facilitates medical research over a long duration. Can experiences from the Norwegian registry be used to develop a European registry to avoid complications? To answer this question, we used the NGER data from February 2013 until March 2015 to analyze the complications of gynecological endoscopy. The registry includes sociodemographic factors, related comorbidity, previous surgery, present procedure, and intraoperative complications. Postoperative complications were identified with a questionnaire administered 4 weeks after surgery. The risk factors leading to complications in gynecological endoscopy were found to be obesity, diabetes mellitus, heart disease, hypertension, previous surgery due to cervical carcinoma in situ, and low educational level. Regional differences in the complication rate were noted. National web-based operation registries such as the NGER can identify the risk factors for complications of gynecological endoscopic surgery and can help improve the outcome after surgery. The experience from NGER can be used to establish a European register.
Highlights
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A national registry for gynecological minimally invasive surgery is proposed.
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Avoiding complications is the best form of prevention.
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The risk factors for complications of gynecological endoscopy are identified.
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The detected risk factors ensure effective prevention and improvement of complications.
Aim
The aim of this study is to determine how complications can be avoided and health-care research optimized in gynecological minimally invasive surgery in Europe.
Introduction
Complications in surgery have emerged as a significant issue. Some complications incurred during surgery pose a significant burden on patient health and cost to society, but the impact of such complications is highly variable.
The total health-care expenditure is the sum of public and private expenditures as a ratio of the total population, which has been increasing worldwide . The expenditures for health care in Switzerland increased from 8.8% of the gross domestic product (GDP) in 1995 up to 10.9% of the GDP in 2013 . The health-care costs in Switzerland in 2013 were about US$ 69 billion, 28% of which were generated by surgical departments . This situation is comparable to those in most European and North American countries . In the USA, the health share of GDP increased from 13.7% in 1993 to 16.2% in 2007. The national health expenditures in the USA increased from US$ 912,5 billion in 1993 to US$ 2.241,2 billion in 2007, with the costs for hospital care in the USA increasing from US$ 317,1 billion (35% of the total health-care costs) in 1993 to US$ 696,5 billion (31% of the total health-care costs) in 2007 .
In the USA, the mean in-hospital cost of all patients without complications were US$ 27,946 (SD US$ 15,106), whereas the mean cost of all patients with at least one complication of any severity was US$ 62,392 (SD US$ 72,470), which significantly increased 2.3 times. Complications graded according to the five-point scaled Clavien–Dindo classification were found to affect costs compared to interventions without complications (US$ 27,946). A grade I complication, for example, generated significant additional costs of US$ 2793 and a grade IV complication of more than US$ 130,000. Complications classified as grade IIIb (intervention under general anesthesia) or higher led to a significant increase in costs compared with procedures without postoperative complications .
All surgical procedures for treating ectopic pregnancy and ovarian cysts as well as hysterectomy for benign indications at all gynecologic departments in Norway from 2003 to 2006 were investigated, and women in this population did not receive the same treatment for the same gynecological disease . These observations may be due to the conventional use of familiar operation techniques and education in laparoscopic procedures.
The risk of complications increases with the complexity of the surgical procedure and the experience of the surgeon . The complication rates vary depending on the available equipment , chosen procedure , socioeconomic status of the patient , and regional and national differences . When data are usually lacking or insufficient, surgical complications only in selected groups can be evaluated. In addition, limited research on medical injuries due to surgery hinders the efficient and qualified evaluation of surgical complications. The results of research on surgical complications vary widely with an overall complication rate ranging from 0.2% up to 10.3% . Moreover, research on complication rates for defined procedures, for example, laparoscopic hysterectomy, has also not produced homogeneous results. The overall complication rate for laparoscopic hysterectomy varies from 1.6% to 10.2% and 11.2% . Sociodemographic characteristics, comorbidity, medical history, indications, equipment, and performing of the different types of procedures affect the outcome of surgery. At present, it is difficult not only to investigate the indication for, performance of, and complications of the surgery in an entire population but also to collect data on risk factors that may or may not affect the incidence of surgical complications.
Medical records provide substantial clinical information that allows the identification of complications and various injuries, but transforming medical records into useful research data on complications and injuries requires both extensive resources and exceptional knowledge and skills in medical settings and research methods . Mandatory medical registries are alternative systems for investigating patient outcomes after surgery and health service research. Adequate and efficient health service research and registration of all surgical complications is possible only with widespread complete data collection.
At present, minimally invasive surgery in gynecology is very common and well established. Sophisticated laparoscopic procedures such as laparoscopic hysterectomy, myomectomy, sacrocolpopexy, and pelvic lymph node dissection have become daily routine operations. Avoiding complications is the best form of prevention; thus, it is crucial to detect risk factors for surgical complications.
In 2012, the Norwegian government and the Norwegian Gynaecological Society (NGF) jointly initiated a national web-based registry for laparoscopic and hysteroscopic procedures. The Vestfold Hospital Trust Tønsberg in Norway developed the register in 2012 in collaboration with the ICT department at University of Tromsø (UiT) – The Arctic University of Norway Registration. Registration was begun in 2013, and participation in the Norwegian gynecologic registry is mandatory according to Norwegian law. To date, the Norwegian Gynecological Endoscopic Registry (NGER) is the first and only web-based national register for gynecological endoscopy worldwide.
The initial results of the NGER show that some of the registered factors such as general health parameters, comorbidity, and previous surgery appear to be associated with a higher risk of complications . Can the Norwegian experience of developing and implementing a gynecological endoscopic registry be used for a European registry to avoid complications?
Introduction
Complications in surgery have emerged as a significant issue. Some complications incurred during surgery pose a significant burden on patient health and cost to society, but the impact of such complications is highly variable.
The total health-care expenditure is the sum of public and private expenditures as a ratio of the total population, which has been increasing worldwide . The expenditures for health care in Switzerland increased from 8.8% of the gross domestic product (GDP) in 1995 up to 10.9% of the GDP in 2013 . The health-care costs in Switzerland in 2013 were about US$ 69 billion, 28% of which were generated by surgical departments . This situation is comparable to those in most European and North American countries . In the USA, the health share of GDP increased from 13.7% in 1993 to 16.2% in 2007. The national health expenditures in the USA increased from US$ 912,5 billion in 1993 to US$ 2.241,2 billion in 2007, with the costs for hospital care in the USA increasing from US$ 317,1 billion (35% of the total health-care costs) in 1993 to US$ 696,5 billion (31% of the total health-care costs) in 2007 .
In the USA, the mean in-hospital cost of all patients without complications were US$ 27,946 (SD US$ 15,106), whereas the mean cost of all patients with at least one complication of any severity was US$ 62,392 (SD US$ 72,470), which significantly increased 2.3 times. Complications graded according to the five-point scaled Clavien–Dindo classification were found to affect costs compared to interventions without complications (US$ 27,946). A grade I complication, for example, generated significant additional costs of US$ 2793 and a grade IV complication of more than US$ 130,000. Complications classified as grade IIIb (intervention under general anesthesia) or higher led to a significant increase in costs compared with procedures without postoperative complications .
All surgical procedures for treating ectopic pregnancy and ovarian cysts as well as hysterectomy for benign indications at all gynecologic departments in Norway from 2003 to 2006 were investigated, and women in this population did not receive the same treatment for the same gynecological disease . These observations may be due to the conventional use of familiar operation techniques and education in laparoscopic procedures.
The risk of complications increases with the complexity of the surgical procedure and the experience of the surgeon . The complication rates vary depending on the available equipment , chosen procedure , socioeconomic status of the patient , and regional and national differences . When data are usually lacking or insufficient, surgical complications only in selected groups can be evaluated. In addition, limited research on medical injuries due to surgery hinders the efficient and qualified evaluation of surgical complications. The results of research on surgical complications vary widely with an overall complication rate ranging from 0.2% up to 10.3% . Moreover, research on complication rates for defined procedures, for example, laparoscopic hysterectomy, has also not produced homogeneous results. The overall complication rate for laparoscopic hysterectomy varies from 1.6% to 10.2% and 11.2% . Sociodemographic characteristics, comorbidity, medical history, indications, equipment, and performing of the different types of procedures affect the outcome of surgery. At present, it is difficult not only to investigate the indication for, performance of, and complications of the surgery in an entire population but also to collect data on risk factors that may or may not affect the incidence of surgical complications.
Medical records provide substantial clinical information that allows the identification of complications and various injuries, but transforming medical records into useful research data on complications and injuries requires both extensive resources and exceptional knowledge and skills in medical settings and research methods . Mandatory medical registries are alternative systems for investigating patient outcomes after surgery and health service research. Adequate and efficient health service research and registration of all surgical complications is possible only with widespread complete data collection.
At present, minimally invasive surgery in gynecology is very common and well established. Sophisticated laparoscopic procedures such as laparoscopic hysterectomy, myomectomy, sacrocolpopexy, and pelvic lymph node dissection have become daily routine operations. Avoiding complications is the best form of prevention; thus, it is crucial to detect risk factors for surgical complications.
In 2012, the Norwegian government and the Norwegian Gynaecological Society (NGF) jointly initiated a national web-based registry for laparoscopic and hysteroscopic procedures. The Vestfold Hospital Trust Tønsberg in Norway developed the register in 2012 in collaboration with the ICT department at University of Tromsø (UiT) – The Arctic University of Norway Registration. Registration was begun in 2013, and participation in the Norwegian gynecologic registry is mandatory according to Norwegian law. To date, the Norwegian Gynecological Endoscopic Registry (NGER) is the first and only web-based national register for gynecological endoscopy worldwide.
The initial results of the NGER show that some of the registered factors such as general health parameters, comorbidity, and previous surgery appear to be associated with a higher risk of complications . Can the Norwegian experience of developing and implementing a gynecological endoscopic registry be used for a European registry to avoid complications?
Material and methods
The legal background of the NGER is the Norwegian Health Register Law passed on 18 May 2001 . The Norwegian Health Register Law strictly follows European Human Rights Law article 8 and European Directory for Data Protection article 16 (95/46/EG) .
The NGER allows medical research and health service research over a long duration as the patient data can be captured. Written patient consent is mandatory for registration. The managing director of the registry is responsible for daily operation, logistics, economy, secure data quality, and supervision of registered users. The advisory board of the registry consists of specialists and patient representatives, for example, from The Norwegian Endometriosis Organization. ICT specialists at UiT ensure online operation of the technical solution. Then they forward the data for evaluation to an expert team at SKDE (Center for Clinical Documentation and Evaluation) in Tromsø.
Doctors and employees in the health service may register as users in the portal. Accepted users are therefore centrally registered. Secure user identification is possible with a two-factor authentification step, which follows a log-on procedure with a username and password as well as a one-time code sent to the user’s mobile phone. Data collection is web based and uses the protected platform OpenQReg © (Geeknet, Fairfax, VA, USA), which utilizes Tomcat, MySQL, and Java .
Registered users have continuous online access to their own anonymous data compared with the results nationwide. The Norwegian health department publishes yearly reports at the department and national level, in which complications, indication for surgery, and implementation are published.
Registration includes the following data:
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Demographic factors are noted, including mother language, education, and marital status.
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General health parameters such as body mass index (BMI), pregnancy, parity, and American Society of Anesthesiologists (ASA) classification are registered.
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Related comorbidities are noted.
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Any previous surgery, including vaginal surgery, laparoscopy, and laparotomy, is registered.
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Details of the present procedure are noted with general data such as primary surgery/reoperation, indication according to the International Classification of Diseases (ICD)-10, anesthetics, and duration of procedure. It is also relevant if the operation is elective or acute and if the operation is conducted during normal operating schedule or on call.
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Furthermore, details of laparoscopy and hysteroscopy with relevant parameters such as laparoscopic access, used instruments, and intraoperative complications are registered specifically.
Four weeks after surgery, a questionnaire was sent by the central office of the registry to document postoperative complications. Patients who failed to respond were contacted by letter and thereafter by telephone to secure the highest possible response rate. The complications were graded to a four-point scaled classification: grade 1, light complication; grade 2, moderate complication; grade 3, serious complication; and grade 4, death.
In this study, we used the registered data of the NGER from 1 February 2013 to 31 March 2015 to analyze the intra- and postoperative complications nationwide. The patients registered in the NGER were matched with the data of the Norwegian Patient Registry (NPR) to investigate completeness . We conducted the chi-squared test to determine any significant difference between the expected complication rate and the observed frequencies in one or more categories. Binary logistic regression analysis was used to measure the effect size of the different factors on the complication rate.
Results
Between February 2013 and March 2015, the details of 3.033 patients were completely documented in the registry. The follow-up rate during this period was 82%. Of the registered procedures, 67% were laparoscopies, 30% hysteroscopies, and 3% a combined procedure of laparoscopy and hysteroscopy. The average age was 47.7 years, the average height 167 cm, the average weight 72 kg, and the average BMI 26. The average number of pregnancies in a single patient was 2.2, and the average birth rate was 1.6.
No significant change was noted in the complication rate of both hysteroscopies ( Fig. 1 ) and laparoscopies ( Fig. 2 ) during the registration period. The average intraoperative complication rate is 3.7% for hysteroscopy and 2.8% for laparoscopy. The most common complications of laparoscopy and hysteroscopy are postoperative infections and hemorrhage ( Table 1 ). The number of postoperative infections is high, warranting further analysis.
