Il consenso informato
Before surgery or any other diagnostic or therapeutic intervention, information is given, and patients have to give their informed consent. It is, however, not unequivocally clear what ‘information’ and ‘informed consent’ exactly means. Both concepts are not strictly defined and tend moreover to change over time and to vary from country to country.
The conflicts between patients and doctors are frequently based upon a perceived lack of information. We believe that the modern web technology provides a unique opportunity to give adequate, updatable information, which is precisely the aim of this site.
What is information ?
There is no doubt that patients should receive information. The content of the information which should be given is more controversial
1. Any information carries a dilemma . Complete, precise and detailed information is practically impossible, since it requires a medical back-ground to fully understand the subtle differences. Moreover this would require a prohibitively long time to give. Another difficulty is that some information is not always wise to give.
2. Information should be given in an understandable language : this is an additional difficulty. The medical language was developed to facilitate communication, between doctors. Without the medical language information becomes imprecise.
3. No uniformity exists about which information should be given : the median standard of care for a given country at a certain point in time, or the best care available at that moment. The prevailing medicolegal standard against which any problem is judged, is ‘the median standard of care in that country at a given moment’. Therefore the median standard is what is generally given as information, and what is translated by professional bodies into ‘Guidelines’. This discrepancy between median standard of care versus best care available becomes especially difficult in periods of transition An example is e.g. when open surgery was and is being replaced progressively by laparoscopic surgery. Hysterectomies can be done by open surgery, as a laparoscopic assisted vaginal hysterectomy , or as a full laparoscopic hysterectomy. The choice and information will depend to a large extend upon the stage of transition of the individual surgeon from open surgery to laparoscopic surgery.
4. For results, risks and complications, the peer reviewed literature is the gold standard and this information should always be given. It should be understood, however , that the peer reviewed literature contains 2 types of information. First the complications reported by centers of exellence devoted to a specific pathology : these groups have more expertise but simultaneously treat more severe pathology. The former will decrease the complication rate, the latter will increase the complication rate. Secondly in the literature overviews of countries or other reviews are reported : these figures obviously are different from those reported by centers of excellence : they contain all surgeons, including those with little experience, and overall deal with less levere pathology
5. It is unclear how detailed the list of complications should be. It is practically impossible and also not desirable to list all the potential complications, even those with a very low risk. It is widely accepted that overall no information is given about complications with a frequency less than 1%.
6. Individual information versus general information. One may ask the question whether individualized information should/can be given for results and complications ? Should the patient receive information about the individual gynecologist’s results and complications ? Should a patient know how experienced a surgeon is in a given operation ?.
7. What is a complication ? A complication is poorly defined. To illustrate this, the following 2 examples are given. Complete excision of endometriosis infiltrating through the bowel wall, requires resection of part of the bowel wall : this is complete surgery, not a complication. The best definition of a complication I could find is ‘a complication is something which was not necessary, or avoidable and which enhances the morbidity or mortality of the patient’. With this definition, any surgery which can be done with equal results by laparoscopy, but is done by laparotomy has the complication of a laparotomy by definition.
What is consent ?
Informed consent can only be given after having been informed. Since information is not clearly defined, it is obvious that consent also is not clearly defined. This moreover varies from country to country, and over time.
For surgery there is the additional difficulty of complications which can occur during surgery, which are generally very rare but which necessitate immediate action, i.e. without the possibility of additional information and consent. This is often solved by asking permission to ‘do whatever might be necessary’. This is difficult for the patient, whereas to give detailed and full information about all possibilities is practically impossible.
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The patient will be informed about
-indication of proposed treatment : i.e. why an intervention is proposed
-alternative treatments : we intentionally will try to give information about all treatments available also when we do not offer them ourselves, and not only about those which are considered ‘standard of care’
-results of treatment : whenever possible, the patient will be informed about our personal results during a given period including the number of patients who have ondergone a similar operation. Simultaneously the standard of care results will be given.
-complications : not only the ‘reported incidences will be given, but also our personal complication rates during a given period, for that intervention.
Information will be given orally. Additionally more detailed information is given for some interventions using brochures etc when available. Given the complexity of the information, which moreover is prone to ondergo changes over time the initiative to develop this web site was taken, in order to provide up to date and individualized information. Each page will have to possibility to be downloaded and printed, and will feature the name of the author and the date it was written.
An informed consent form will have to be signed by the patients
On this form will be written
-which information was given
-who gave the information
-for which operation/intervention the patients gives consent
-which intervention the patient does wants not to have , e.g. removal of an ovary or a uterus.
-who gave the consent to do a specific intervention eg the parents for minors.
-eventual additional consent : eg to store data of the patient in a database for later scientific use, to store blood, fluid or tissue samples for later research use.
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Questions to ask before surgery and before giving Informed Consent
For the patient it is important to get full information before surgery. The consent you give should be clear and unequivocal. Below are some guidelines of information the patient should have before signing informed consent for surgery.
1. How experienced is the surgeon in the surgery of endometriosis.
- To judge this ask the number of cases operated per year and the total number already operated. I operate some 400 women with endometriosis/ year and operated more than 4000 in total.
- More specifically ask how many deep endometriosis lesions of more than 2 cm in diameter have been treated. This will be a fair estimate of the experience to handle bowel, ureter and bladder endometriosis. I Operated more than 500 women with large rectovaginal nodules.
2. Which type of surgery will be performed This should be explained in detail and written unequivoqually in the informed consent. The reason why this is important, is the discrepancy between the the best available treatment and the treatment which is mostly used by the median surgeon in a country or region at a given moment. The latter is what is defined medicolegally as a normal treatment, unless defined otherwise in the informed consent. Specifically for ednometriosis I consider it important that .
- the surgeon can perform excision of typical lesions. Coagulation/vaporistion only can be misleading.
- the surgeon excises cystic ovarian endometriosis of less than 5 cm diameter. Coagulation/vaporisation only is associated with a higher recurrence rate and is often is a symptom of less experience in advanced endoscopic surgery.
- large cystic ovarian endometriosis of more than 6-7 cm should generally be treated as a two step procedure. Treatment in one step generally results in the removal of appreciable amounts of ovarian tissue. For infertility patients this is crucially important. For women over 40 years with only pain symptoms, it may be discussed to remove the ovary, since this is a simpler procedure.
- How will deep endometriosis be handled. It is mandatory that deep endometriosis is not treated without bowel preparation. If the surgeon is not experienced to excise deep endometriosis, it generally is a fair deal is that deep endometriosis will not be treated and that the patient is referred to somebody with experience.
3. What is the risk that a laparotomy or other unexpected surgery will have to be performed during surgery for endometriosis. In my practice, I estimate these risks are as follows.
-for subtle and typical endometriosis : untill today 0%.
-for cystic ovarian endometriosis : untill today I never removed an ovary and since 1995 I never performed a laparotomy for cystic ovarian endometriosis unless agreed clearly before surgery. The exceptions to remove an ovary are eg a women of 45 years, without any wish for conception and with a large cyst or multiple cysts, since an adnexectomy is much easier than a cystectomy.
- for deep rectovaginal endometriosis : since 1995 and untill today all patients -even with lumps up to 6 cm in diameter- have been treated conservatively without one laparotomy.
- for larger deep sigmoid endometriosis it sometimes is preferable to do a sigmoid resection with an end to end anastomosis -in my experience less some 5 %-. Whether this can be done by laparoscopy or laparotomy depends on the experience of the local bowel surgeon.
- the risk of a hysterectomy clearly is 0%.
4. What is the recurrence rate of endometriosis after surgery. Fair estimates are
- 3% to 7% for cystic ovarian endometriosis
- around 1% for deep endometriosis. I consider any recurrence of deep endometriosis within a few years to be caused by either a incomplete surgery or a missed diagnosis. Since surgery for deep endometriosis -especially the larger ones- always is a compromise between aggressive surgery and larger resections of bowel wall and of ureter and bladder wall (and thus of the risk of complications after surgery) and complete surgery (with less recurrences) prudent surgery will depend on the expertise and the judgment of the surgeon.
5. Is the surgeon prepared to tape the whole procedure and give you a copy of the surgery. This probably will be charged extra because of the work involved. It anyway give a good estimate of the surgical skills and experience. An often heard criticism is that this will show any mistakes or errors and that this is actually inacceptable in the medico-legal climate we are living in. I believe that the best relationship is an open one, where the patients knows what the experience of the surgeon is, knowing that nobody is perfect and that any surgeon will make occasionnally a mistake -errare humanum est.
