Key words
adhesions - adhesion prophylaxis - awareness - patient education - lawsuit
Schlüsselwörter
Adhäsionen - Adhäsionsprophylaxe - Wahrnehmung - Aufklärung - rechtliche Konsequenzen
Background
Adhesions following surgery have long been known, and the first scientific paper on
the subject was written more than 100 years ago [1]. However, an understanding of the fundamental pathomechanisms involved has only
been achieved over the last decades. Numerous studies have been performed on the consequences
of adhesions for patients as well as on the associated implications for the health
system [2], [3], [4]. The results of these studies are clear and pose the question of whether the scientific
work of the last few decades has influenced awareness of adhesions in daily practice.
In particular, surgeons who perform abdominopelvic operations should have a specific
interest in the subject since patients should be educated as a matter of course on
high-incidence complications. The occurrence of adhesions varies from study to study
and lies generally between 20 and 93 percent [5], [6], [7], [8], [9], [10]. Adhesions can currently be considered the most commonly recorded complication following
abdominopelvic surgery.
The present article provides a short overview and pays particular attention to the
level of awareness of adhesions among physicians and patients. The potential legal
consequences of patient education and consent are discussed, and a patient information
form developed by the authors is proposed.
Formation of Adhesions
Adhesions are bands of connective tissue which join two normally separate anatomical
structures. As a reaction to a peritoneal trauma, for instance due to inflammation
(inflammatory processes) or surgery, increased vessel permeability occurs during normal
healing, resulting in a migration of inflammatory cells and accumulation of fibrin.
Among others, fibroblasts also migrate into the fibrin matrix where they produce extracellular
matrix components, thereby modifying the fibrin matrix. The accumulated fibrin can
normally be broken down by the fibrinolytic system. However, if the fibrin is not
degraded due to reduced fibrinolysis, the fibrin matrix becomes the basis for adhesion
formation [11], [12]. In a further process, the initially reversible connective tissue bands can undergo
stable reconstruction and become vascularised and innervated [13], [14]. The formation of adhesions is a complex process involving changes in the fibrinolytic
system itself and the various cytokines which influence the fibrinolytic system [15], [16]. Hypoxia is an important factor. Studies on fibroblasts have shown that collagen
synthesis is stimulated under hypoxia conditions, and factors in the fibrinolytic
system are influenced in terms of antifibrinolytic activity [17], [18]. Other influencing factors are the cytokines released during an inflammatory reaction.
Increased concentrations of proinflammatory cytokines are found in the peritoneal
fluid of patients with adhesions [19], [20]. These cytokines are capable of stimulating the fibrinolytic system factors, thereby
causing an antifibrinolytic effect [21], [22]. In abdominopelvic surgery, an inflammatory reaction as well as hypoxia can be more
marked as a result of an extensive surgical trauma, peritoneal sutures or the use
of electrocoagulation. Moreover, laparoscopic interventions can result in damage to
the peritoneum through a negative effect of the pneumoperitoneum on the peritoneal
cells or dehydration of the cells when using dry insufflation gas. The formation of
adhesions is thus stimulated [23], [24], [25], [26].
Complications Resulting From Adhesions
Complications Resulting From Adhesions
Adhesions form within 3–5 days; however, complications associated with the adhesions
often become clinically relevant and indicate symptoms only some time after the initial
operation. One of the most significant complications is mechanical ileus, with adhesions
representing the most common aetiology. A recent review of 29 studies investigating
the causes of acute ileus indicated that adhesions accounted for 85 % of acute small
bowel obstructions. In general, acute ileus is responsible for 5 % of hospital admissions,
and 50 % of these cases are treated surgically [27]. Furthermore, adhesions can have a negative impact on fertility. However, only a
few studies, some of which are older, have been conducted on the influence of adhesions
on fertility [28], [29], [30]. Two small, prospective studies have indicated that the use of an adhesion barrier
resulted in a higher pregnancy rate in comparison with the control group [31], [32]. Other complications caused by adhesions include the development of chronic pelvic
pain [33] as well as difficult and prolonged subsequent surgeries with the risk of inadvertent
damage to the intestine, blood vessels or urethra [3], [34]. The considerable costs of treating complications caused by adhesions constitute
a burden on the health system [4], [35]. Considering the significant consequences of adhesions, it is essential that surgeons
performing abdominopelvic operations establish a strategy for preventing adhesions.
Patients should be informed as a matter of course on the risks associated with adhesions
and ways of minimising these risks.
Prevention of Adhesions
In addition to meticulous surgical techniques and careful handling of connective tissues,
strategies for minimising the risk of adhesion formation include reduced suturing
and minimised tissue trauma by limited use of electrocoagulation. Coagulation time
and frequency should be reduced, and aerosolised tissue arising from electrocoagulation
should be aspirated. Foreign bodies, such as materials with loose fibres, should be
avoided. The use of wet instead of dry cloths or sponges and the use of starch-free
and latex-free gloves during laparotomy are recommended measures. A reduction of pressure
and duration of the pneumoperitoneum during laparoscopy can limit the occurrence of
adhesions. The peritoneum should be thoroughly rinsed during laparoscopy as well as
laparotomy in order to reduce dehydration of the peritoneal cells [36].
Currently there is no certain way of predicting which operations and which patients
will present with symptomatic adhesions. Adhesion prophylaxis should be considered
in the form of anti-adhesion devices following abdominopelvic surgery. Currently no
systemic pharmaceutical products are available for reducing adhesions. All available
products are designed to mechanically separate the injured tissue from the surrounding
organs during the healing process. There is no doubt that these products can in principle
reduce adhesions following abdominopelvic surgery. However, current data do not clearly
indicate the factor by which a reduction is possible because the reductions achieved
vary depending on the device used and the study undertaken. A large, randomised, double-blind
study (n = 402) comparing the use of an adhesion barrier with a purely Ringer lactate
solution instillation indicated a significant difference in the reduction of new adhesions.
In the treatment group (n = 203), 47 % of patients developed new adhesions compared
with 57 % in the control group (n = 199). In this study, clinical success was defined
as a reduction in the number of sites of adhesion occurrence of at least 3 or 30 %
following adhesiolysis. In the treatment group, clinical success was recorded in 49 %
of patients compared with 38 % in the control group. In the subgroup of infertile
female patients, 55 % in the treatment group (n = 102) indicated clinical success
compared with 33 % in the control group (n = 112) [37]. A further large, prospective blind study (n = 546) investigated the efficacy of
the adhesion barrier following myomectomy. The incidence of adhesions was assessed
in a second-look laparoscopy and indicated the following: abdominal myomectomy without
adhesion barrier (28.1 %; n = 154), laparoscopic myomectomy without adhesion barrier
(22.6 %; n = 155), abdominal myomectomy with adhesion barrier (22 %; n = 154) and
laparoscopic myomectomy with adhesion barrier (15.9 %; n = 157) [6]. Other studies have been the subject of meta-analyses [38], [39]. Due to uncertainty of the efficacy of anti-adhesion agents, it is difficult for
physicians to decide on which agent to use. Moreover, many adhesion barriers are still
very expensive and are seldom reimbursed by health funds. A validated, scientific
re-evaluation of the efficacy of anti-adhesion products, combined with a thorough
patient education are urgently needed in order to establish the use of these products.
Physician Awareness
Questions are increasingly being asked about adhesion awareness on the part of the
physicians and patients. One might expect that the results of experimental and clinical
studies during the past decades would have increased awareness among physicians, and
that patients are being better informed on adhesions. The following paragraphs provide
an overview of three studies on physician awareness in relation to adhesions. Surgically
active gynaecologists in Germany [40] and Great Britain [41] as well as general surgeons and gynaecologists in The Netherlands [42] were surveyed.
In Germany, a questionnaire was sent to all gynaecological clinics and was completed
by the respective head physician or one of the specialists. The results of the study
indicated a high level of awareness by German gynaecologists. The response rate was
34 % (279/833), suggesting that the questionnaires tended to be completed by physicians
with a specific interest in the subject. The majority of surveyed gynaecologists (66 %)
confirmed that patients with adhesions made up a significant proportion of their daily
surgical activities. Although over 60 % of the respondents agreed that adhesions were
accompanied by considerable morbidity in their patients, only 38 % used adhesion barriers
in routine practice [40].
In Great Britain, the questionnaire was sent to all members of the Royal College of
Obstetricians and Gynaecologists, with a response rate of 10 % (390/4010). About 94 %
of the surveyed gynaecologists confirmed that adhesions gave rise to serious consequences
and agreed that adhesion barriers should be used in operations with a high risk of
adhesion formation. 65 % of the respondents were even of the opinion that adhesion
barriers should be used in all operations. When asked about their current anti-adhesion
strategy, however, less than 10 % indicated the use of adhesion barriers in their
daily routine [41].
The response rate from the Netherlands was 34 % (501/1455) and showed a similar outcome:
67 % of those surveyed confirmed the clinical relevance of adhesions, but only 13 %
had used an anti-adhesion agent during the year preceding the survey [42].
In summary, the majority of surgeons were relatively well informed with regard to
the individual survey questions, but only a minority actually used adhesion barriers
in routine practice. This result emphasises the difficulty in evaluating the benefits
of anti-adhesion agents and operations performed according to anti-adhesion standards.
The studies also indicated that even the surveyed surgeons do not inform their patients
sufficiently. Only 10 % of the surgeons in the Netherlands stated that they informed
their patients about adhesions as a matter of routine, while 41 % stated that they
had never mentioned adhesions to their patients. In Great Britain, only 23 % of gynaecologists
informed their patients prior to all operations and 38 % prior to some operations.
Only 2 % of the respondents offered their patients written information on the subject
[40], [41], [42]. In Germany, 83 % of the gynaecologists surveyed informed their patients on adhesions.
However, a recent prospective study investigating the process of patient education
in a German university clinic indicated that adhesions were discussed in only 44 %
of consultations. If adhesions are not routinely discussed prior to all abdominopelvic
operations, despite the fact that they are common and can have serious consequences,
other sources are the only possibility to increase patient awareness of the issue.
Ideally, however, the best source of information should be the consultation between
doctor and patient.
Patient Awareness and Legal Consequences
Patient Awareness and Legal Consequences
A recent study of the awareness of adhesion by patients conducted in two hospitals
in Great Britain and in one Germany university medical centre corroborated the hypothesis
that patients are not being sufficiently educated on adhesions [43]. In Germany, 44 % of doctors at the university medical centre discussed adhesions
during their patient consultations, but only 39 % of these patients felt satisfactorily
informed. In Great Britain, 27 % of patients were informed about adhesions during
consultations. The authors assumed that the variance in percentages between Germany
and Great Britain was due to the difference in type of consultation. Since no written
consent form is used in Great Britain, the authors assumed that doctors often forgot
to discuss adhesions. In Germany, on the contrary, written consent forms are used
in which adhesions are listed together with other complications. By virtue of this
fact, the information rates indicated in Germany are to be considered particularly
low. Nevertheless, the study showed that patients who had been informed about adhesions
indicated their doctor had been the main source of information. This further emphasises
the importance of consultations [43].
An information form specifically aimed at discussing the problem of adhesions is a
very useful aid for patient and doctor during a consultation. For the patient, a form
written in clear and simple language can help prepare for the discussion with the
doctor. For doctors, the routine use of a form can be a reminder to discuss the risk
of adhesions with the patient and can provide professional information with which
to correctly inform the patient. Professor De Wilde has worked in collaboration with
the medical publisher Perimed Fachbuch Verlag to develop an information form focused
on adhesions in abdominopelvic operations, see [Fig. 1]. An information form can and should never be a substitute for a personal consultation.
Nevertheless, it offers patients important information and can serve as evidence for
the physician at any time, especially in cases of legal disputes, that the patient
was informed about adhesions and the associated complications.
Fig. 1 Perimed information form.
Guidelines can prompt physicians to discuss serious complications during each consultation,
even when the probability of occurrence is low. Less serious complications must be
discussed if their occurrence is common [44]. Since a precedence setting case in Great Britain, physicians are deemed negligent
if they do not inform patients of complications with a risk of over 1–2 % [45]. Depending on the operation, the 5-year risk of a hospital admission due to complications
caused by adhesions lies well over the 1–2 % risk factor [46]. Nevertheless, a study conducted in Great Britain indicates that complications caused
by adhesions are only noted on 9 % of information forms [47].
The number of successful lawsuits due to adhesion-related complications is increasing
[48]. It is in the interests of surgeons, therefore, to be prepared for potential claims
and to be in a position to provide evidence that patients are routinely informed on
possible complications from adhesions. This is particularly important since a reversal
of evidence may be imposed by law in Germany by virtue of which the physician is obliged
to provide proof of informing the patient [49].
Conclusion
Adhesions are of major clinical significance and should be considered to be the most
frequent complication following abdominopelvic surgery. Although physicians consider
the issue important, a considerable number of patients are not being routinely informed
about adhesions and the potential associated complications. It is in the interests
of patients and physicians to educate patients on the risks of adhesions and on the
currently available preventive measures. Although the information form cannot and
should not be a substitute for a personal consultation, it is a very useful communication
aid between physician and patient and serves as documentary evidence of the consultation.
Five Key Statements
-
Today, adhesions are the most common complications following abdominopelvic operations.
-
Adhesions potentially have serious consequences for patients, such as acute small
bowel obstruction, infertility, chronic pelvic pain and complications during follow-on
operations.
-
A sound surgical technique and the use of laparoscopy cannot totally prevent the formation
of adhesions; the use of adhesion barriers in abdominopelvic operations should be
considered.
-
Currently, patients are not being sufficiently informed about adhesions and the potential
resulting complications; this may lead to successful lawsuits against treating physicians.
-
Prior to any abdominal operation, patients should be routinely informed about adhesions
by means of a written consent form.
