Informed consent

Before surgery or any other diagnostic or therapeutic intervention, information should be given, and informed consent should be obtained. 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.

Which information should be given ?

Any information carries a dilemma . Complete, precise and detailed information is practically impossible, since it requires a medical back-ground to fully understand subtle differences. Moreover this would require a prohibitively long time to give the information . Another difficulty is that some information is not always wise to give. Information should be given in an understandable language :  The medical language was developed to facilitate communication, between doctors. Without the medical language information tend to become imprecise.

Information on the diagnosis and the planned surgery.

How certain is the diagnosis Since not all diagnoses can be made with 100% certainty before surgery, it is wise to discuss beforehand what should be done when the diagnosis turns out to be wrong. As an example : deep endometriosis which can be an unexpected diagnosis during surgery. It should be clear whether the intervention can be done (provided a bowel preparation was given) or whether this has to be discussed with the patient first. It becomes more difficult when the surgeon does not have the level of experience and when the alternatives are either to stop the intervention and to refer, or to try and often end with incompplete surgery, or -and this occurs- do an hystrectomy and leave the endometriosis untouched.
Which intervention is planned and what are the alternatives ? Unfortunately the standard of care for a given country at a certain point in time is not necessarily the best care available at that moment. The prevailing medicolegal standard to judge an intervention is ‘the median standard of care in that country at a given moment’ . This is translated by professional bodies into ‘Guidelines’.
The standard of care, however is not necessarily the best care available eg hysterectomy by open surgery or laparoscopically. Since today the numerous advantages for the patient of a laparoscopic hysterectomy are well established, this information should be given even if the surgeon does not perform laparoscopies himself. The medicolegal standard of care, cannot be an excuse not to give information concerning alternative treatments.

Information on results and complications .

Results are known to vary with the experience of the surgeon, being worse during the learning curve. Therefore the patient should be informed about the personal experience and results of the surgeon for the intended intervention. The results reported in the peer reviewed literature are the benchmark but it should be understood that those publishing their results are generally well experienced.
Also complications vary with experience . The reports on complications in the peer reviewed literature, can be those reported by centers of exellent surgery devoted to a specific pathology which have more expertise but simultaneously treat more severe pathology. The former will decrease the complication rate, the latter will increase the complication rate. In addition the literature contains complication reviews of countries with incidences which generally are much higher. This decrepancy highlights the difference between the’standard of care and the best care available.

The most important aspect however is to distinguish between necessary surgery, acceptable complications and unacceptable complications or errors.

Necessary surgery is eg the full thickness removal of a deep endometriosis lesion since otherwise the surgery would have been incomplete.
Acceptable complications are eg a ureter lesion for deep endometriosis excision in association with an hydronefrosis, for which we reported 18% lesions. The same holds true for the 5-1% late bowel perforations after deep endometriosis excisions.
unacceptable complications generally are a consequence of inexperience or lack of care. It is unclear how fatique should be judged.
Without systematic videoregistration of the entire intervention, it almost invariably is impossible to distinguish between necessary surgery, acceptable complications and medical mistakes. For this reason videoregistration is standard for our group in Belgium and the gruppo Italo Belga in Italy. In addition we try to publish all our complications in an effort to think about eventual prevention, and in order to help others not to make the same mistakes.

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%.

What is informed consent ?

Informed consent can only be given after having been informed. Besides information and consent, the vary rare and unpredictable events constitute a problem.
Therefore the informed consent form should contain the following elements
-which information was given and by whoim
- the accuracy of the diagnosis and what the probability is that the diagnosis is wrong
- the intended intervention and the alternative treatments including those that the gynaecologist is unaible to perform himself. Thus information on the standard of care clearly is insufficient
-the expected results of surgery. ie the personal results of the surgeon and the number of patients who have ondergone a similar operation. In addition the standard of care results can be given.
-which intervention the patient does wants not to have , e.g. removal of an ovary or a uterus.
- Complications of surgery . At least the standard reported complications should be mentioned. If available the surgeon can give personal data, preferably published in the peer review literature.
- the experience of the surgeon
- whether the intervention will be videorecorded and whether you will get a copy
-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.

Practical questions to ask before giving informed consent for endometriosis surgery

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 endometriosis surgery.
- what is the personal esperience of the surgeon 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 5000 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 200 women with large rectovaginal nodules.
- 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 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 endometriosis I consider it important that the surgeon can perform excision of typical lesions (Coagulation only can be misleading), that the surgeon will excise 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), that large cystic ovarian endometriosis of more than 6-7 cm will be treated as a two step procedure (Treatment in one step generally results in the removal of appreciable amounts of ovarian tissue) 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. 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 that 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 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 some 10 %-. Whether this can be done by laparoscopy or laparotomy depends on the experience of the local bowel surgeon. The risk of an 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 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.