Informed consent requires complete information
There is no informed consent without correct information of
- the indication of surgery
- the planned surgery
- the alternatives
- the personal experience, the complications and the results of the surgeon for this intervention.
Rules of thumb to judge information
Videoregistration should be used as quality control
- The literature is difficult to interpret by non-specialists, and hypotheses and speculation create false expectations. In addition, the information is difficult to interpret by zooming in on details without the larger picture (something that is normal in peer-reviewed literature since the reader is supposed to be able to interpret the data ).
- Websites and the lay press are not peer-reviewed.
- Important is the credibility of the author? This can be judged by his/her background and publications.
- Those who do not do surgery could give biased information on surgery.
- Controversies should be explained. Even well-performed Randomized Controlled Trials can be interpreted differently. It is useful to understand the background of the controversy and to know what the position is of a doctor.
Surgery can only be judged by video-registration
Video registration is an indication that the surgeon feels confident.
The patient has the right to consent well-informed, freely and in advance to any service provided by a health professional. The consent of the patient is only valid for the medical intervention consented to……see full text
Patients Rights in the EU https://europatientrights.eu/ Click for Belgium Click for Italy More information for other European countries
Medico-legally correct is the knowledge and practice of the median gynaecologist at that moment
thus not
The best or the state of the art
The ideal informed consent
- which information was given
- by whom
- the accuracy of the diagnosis and the probability that the diagnosis is wrong
- the intended intervention
- the alternative treatments
- the expected results of surgery. i.e. the personal results of this surgeon for this intervention.
- Which intervention does the patient want not to have, e.g. removal of an ovary or a uterus?
- Complications of surgery. At least the standard reported complications should be mentioned.
- Whether the intervention will be video-recorded, and whether you will get a copy
- of who gave the consent to do a specific intervention, e.g. the parents of minors.
- Eventual additional consent: e.g. to store data of the patient in a database for later scientific use, to store blood, fluid or tissue samples for later research use.
Practical questions to ask before giving informed consent
The consent you give should be clear and unequivocal. Below are some guidelines of information the patient should have before signing informed consent for endometriosis surgery.
What is the personal percipience of the surgeon To judge this ask the number of cases operated per year and the total number already operated. More specifically, ask how many deep endometriosis lesions of more than 2 cm in diameter have been treated. We did operate on some 400 women with endometriosis/per year and operated on more than 4000 deep endometriosis.
Which type of surgery will be performed This should be explained in detail and best written unequivocally in the informed consent. The reason why this is important is the discrepancy between the best available treatment and the treatment which is used by the median surgeon in a country or region at a given moment. The latter is what is defined medico-legally as a normal treatment unless defined otherwise in the informed consent. Specifically for endometriosis, I consider it important that the surgeon will excise cystic ovarian endometriosis of less than 5 cm diameter (Coagulation/vaporization only is associated with a higher recurrence rate and is often a symptom of less experience), that large cystic ovarian endometriosis of more than 6-7 cm will be treated as a two-step procedure unless in women over 40 years with only pain symptoms where removal of the ovary can be considered since easier. It should be clear how deep endometriosis be handled. If the surgeon is not experienced in excising deep endometriosis, it is fair that unexpected deep endometriosis will not be treated and that the patient is referred to somebody with experience.
What is the risk that a laparotomy or other unexpected surgery? We estimate these risks are as follows :
- for subtle and typical endometriosis: until today, 0% ;
- for cystic ovarian endometriosis: until today, I never removed an ovary, and since 1995, I never performed a laparotomy for cystic ovarian endometriosis unless agreed clearly before surgery.
- For deep recto-vaginal endometriosis: since 1995 and until today, all patients, even with large nodules up to 6 cm in diameter, have been treated without one laparotomy; for larger deep sigmoid endometriosis it sometimes is preferable to do a sigmoid resection anastomosis -in our experience some 10 %-.
- The risk of a hysterectomy clearly is 0%.
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 gives a good estimate of the confidence of the surgeon, his surgical skills and experience. An often-heard criticism is that this will show any mistakes or errors and that this is actually unacceptable in the medico-legal climate we are living in. I believe that the best relationship is an open one, where the patient knows what the experience of the surgeon is, knowing that nobody is perfect and that any surgeon will make occasionally a mistake -errare humanum est.
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