Miscellaneous gynaecology

Injuries in obstetric and gynaecological practice: overview 772 Ureteric injury 774

Bladder and urethral injury 776 Communication and record keeping 778

Medico-legal aspects of obstetrics and gynaecology: overview 780

Consent to treatment 782 Consent: other issues 783

Consent for common gynaecological procedures: overview 784 Consent for surgery that breaches the peritoneum 786 Consent for surgery that enters the uterine cavity 788 Considerations for preoperative assessment in gynaecology 789 Clinical risk management: identifying and analysing risks 790 Clinical risk management: risk reduction 792

Gynaecological imaging I 794 Gynaecological imaging II 796 Gynaecological imaging III 797 Gynaecological imaging IV 798

772 CHAPTER 24 Miscellaneous gynaecology

Injuries in obstetric and gynaecological practice: overview

Because of their close anatomical relationship, operating on the genital tract may also incur injury to the urinary tract. Complicated gynaecological procedures increase the risk of urinary tract injury. If an injury occurs, prompt recognition and appropriate management are important both to prevent long-term sequelae (urinary incontinence, fistulae, and, rarely, renal failure) and to reduce litigation related to the injury.

Medico-legal implications

Up to 6% of all medical malpractice claims in gynaecological practice are related to urinary tract injuries. The quantum of claims is probably related to the degree of suffering or perceived suffering by the patient. Thus, urinary tract injuries that lead to litigation are likely to be associated with significant physical and psychological morbidity or loss of income.

Claims have increased over time and every attempt should be made to reduce the risk—despite every effort, occasional injury is inevitable, particularly with highly challenging surgery.

In the event of an adverse event

Remember the GMC guidance on being open and honest with patients:

•If a patient under your care has suffered harm or distress, you must act immediately to put matters right, if that is possible. You should offer an apology and explain fully and promptly to the patient what has happened, and the likely short-term and long-term effects.

•Patients who complain about the care or treatment they have received have a right to expect a prompt, open, constructive, and honest response including an explanation and, if appropriate, an apology. You must not allow a patient’s complaint to affect adversely the care or treatment you provide or arrange.

Remember, doctors who are open, honest, and non-defensive are less likely to be sued for negligence and less likely to have formal complaints made about them, regardless of what has gone wrong.

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URETERIC INJURY 775

Presentation

Postoperatively, uretric injury presents with:

•Fever (sepsis).

•Flank pain from hydronephrosis.

•Vaginal fistulae.

•Non-specific symptoms of malaise, ileus, or the presence of a pelvic mass (‘urinoma’).

•Bilateral ureteric injury is very rare, so renal function is usually normal.

Risk factors for ureteric injury

•Previous surgery.

•Bulky tumours distorting anatomy and/or displacing ureters.

•Endometriosis with peritoneal scarring or frozen pelvis.

•PID and tubo-ovarian abscesses.

•Carcinoma of the cervix with parametrial involvement.

•Situations that require haste (e.g. CS).

•Angular or broad ligament tears during CS.

Prevention is better than cure!

Identification of the ureters prior to ligation of the uterine and ovarian arteries during hysterectomy should be routine practice. If difficult surgery is anticipated or encountered identification aids include:

•Preoperative ureteric stents (can be ‘lighted’).

•IV administration 10mL indigo carmine or methylene blue with 20mg of furosemide. Leakage of dye or contrast is demonstrated with ureteric injury.

•Retrograde pyelography under fluoroscopic guidance (identifies ureteric strictures).

BLADDER AND URETHRAL INJURY 777

Urethral injury at a glance

Female urethral injuries are rare, and they occur commonly with urethral instrumentation, vaginal surgery, and obstetric complications. Most commonly the result of difficult catheterization where it is forced and there is rupture or subsequent scarring of the urethra.

Presentation

•Diagnosis can be difficult, but they can present with urethral bleeding or an inability to void (retention or poor stream and dribbling).

•Fistulae will present with labial swelling or with leaking of urine through the vagina.

Diagnosis

•IVU.

•Voiding cystourethrography.

•MRI.

•Cystoscopy.

Treatment

•For most cases urethral catheterization is sufficient if this is possible.

•Suprapubic catheterization may be necessary prior to formal repair.

•Larger tears are surgically repaired using layered closure.

•Proximal damage to the urethra requires reconstruction surgery including bladder flap–urethral tube reconstruction and vaginal flap urethroplasty.

•Long-term suprapubic catheterization may be necessary in the small group of women for whom urethral repair is unsuccessful.

Urethral surgery is very difficult and requires expert urological input.

Risk factors during Caesarean section

•Emergency CS, particularly category 1.

•Low station of the presenting part (especially at full dilatation as the bladder is stretched up the lower segment and is ‘higher than expected’).

•Prolonged labour prior to section.

•Preterm delivery (<32wks gestation).

•Previous CS (risk increases with increasing number of CS).

•Previous extensive abdominal and pelvic surgery, especially previous myomectomy.

•The presence of lower uterine and cervical fibroids.

•Operator skill.

COMMUNICATION AND RECORD KEEPING 779

Good documentation

•Always record correct date and time of every patient encounter.

•Ensure name, date of birth, and identifying number are on every sheet of paper.

•Always write legibly in black ink.

•If entries need to be changed/altered then cross out old entry, but leave it visible and legible and sign and date new changes.

•Never alter or remove pages from notes when things may have gone wrong—they have usually been photocopied already!

•Always identify yourself by signature, printed name, and position.

•Identify all people present for any discussions (especially interpreters).

•Keep notes contemporaneously wherever possible (you never remember things quite as they were if there is a time delay).

•If you need to back-date an entry (e.g. if you are called to deal with an emergency) then indicate that this is back-dated and what time the actual event refers to.

•Document discussions fully, particularly possible complications; ‘complications of laparoscopy explained’ will not stand up to scrutiny or challenge after a bowel injury!—see b Consent to treatment, p. 782.

•For operative procedures or diagnostic imaging, take hard-copy prints or preferably archive images wherever possible—a diagram may also be useful.

•If you need to deviate from a guideline then fully document your reasons for doing so in the given clinical situation including when discussed with a colleague.

•Avoid abbreviations and acronyms wherever possible, or explain them (IUD = intrauterine device or intrauterine death!?).

•Never make jokes or flippant comments: they are distasteful, notes are a legal document, and patients can access their files—how would you feel if your notes said ‘needs a checkup from the neck up’?

•For operative procedures or diagnostic imaging, take hard-copy prints or preferably archive images wherever possible—a diagram may also be useful.

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Medico-legal aspects of obstetrics and gynaecology: overview

It is good medical practice for all doctors to have a basic understanding of the law and its relationship with medicine. For the obstetrician and gynaecologist it is essential, because of the many complex medico-legal issues dealt with on a daily basis. The two largest areas for medico-legal claims are A&E and obstetrics.

UK law and the court system

The legal system in England and Wales is quite different from that in Scotland, although many of the principles are the same. What is described here is the English system. Medico-legal cases may be heard in different types of court. The court system is hierarchical. The Supreme Court is the most senior court in the land followed by the Court of Appeal and the High Court. Laws are made in a variety of different ways.

Common law

This is law that is developed over time through decisions made by judges. These decisions establish legal principles or ‘precedent’ which can be applied to future cases. Precedent set by a higher court such as the Supreme Court overrules that of a lower court. Medical law regarding clinical negligence is largely derived from common law.

Statute law

These are laws made by parliament. Statute law overrides common law developed by the courts. Many medico-legal issues in obstetrics and gynaecology are governed by statutes, such as the Abortion Act 1967.

Medical negligence

In order to establish that negligence has occurred, it must be shown that on the balance of probabilities:

•The doctor or hospital had a duty of care.

•There was a breach of that duty.

•The breach of duty caused harm to the patient.

MEDICO-LEGAL ASPECTS OF OBSTETRICS AND GYNAECOLOGY 781

What is medical negligence?

•Claims for medical negligence are both more common and more costly in obstetrics and gynaecology than in any other specialty.

•The National Health Service Litigation Authority (NHSLA) has dealt with nearly £2 billion of claims by patients since 1995.

•Claims are usually made against doctors (in practice a claim is made against a hospital trust) in civil law rather than criminal charges.

•Medical negligence is the legal term used when harm arises because of a breach of duty by an individual clinician or a hospital:

•an inappropriate treatment or failure to make a correct diagnosis may be found negligent if the patient suffers harm as a result

•it may be judged negligent to fail to warn a patient about a risk inherent in an operation, e.g. ureteric injury during hysterectomy.

•The standard used to decide if a doctor breached his or her duty of care is whether a responsible body of medical opinion, acting in a logical manner, would have acted differently in the same circumstances.

•It also has to be proved that, on the balance of probabilities, it was the breach of duty that caused the harm. Thus, where an abnormal CTG was not acted upon and a baby develops CP, negligence will only be established if the CP is shown to be caused by hypoxia during labour and not another cause.

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Consent to treatment

1Treating an adult without her consent may lead to claims of negligence or, more rarely, a claim of battery.

Consent

In order for consent to be valid the patient must:

•Have the capacity to give consent.

•Give consent voluntarily.

•Be given appropriate information regarding the procedure.

Capacity

•The Mental Capacity Act 2005 has defined capacity in law.

•The pain and distress caused by labour is not enough to determine that a woman lacks capacity to consent.

Assessment of capacity

The person will lack capacity if there is a disturbance in the functioning of the mind or brain so she cannot:

•Understand the information relevant to the decision.

•Retain the information.

•Use or weigh the information.

•Communicate the decision.

Voluntary consent

Consent must be given freely, without undue influence or pressure from others.

Information

To avoid a claim of battery, a patient must be aware of the nature and purpose of any procedure to which she consents. For example, when a medical student is to perform a vaginal examination, it must be clear to the patient that the purpose is to enhance the student’s training and not for the benefit of the woman. More commonly, lack of information during the consent procedure may give rise to a claim of negligence.

Consent for operations

The law does not specify who can take the consent for an operation, but the person obtaining consent should, at the very least, be familiar with the procedure and be able to explain it in detail. Thus in complex cancer or laparoscopic surgery it may be wise for the operating surgeon to obtain the patient’s written consent.

The Department of Health has published guidance on what information should be given to patients before an operation. This includes:

•Details of the proposed procedure.

•The nature of the condition being treated.

•The benefits of treatment.

•Alternative treatments.

•Serious and frequently occurring risks.

•Additional procedures that may be necessary, e.g. blood transfusion.

CONSENT: OTHER ISSUES 783

Consent: other issues

Refusal of treatment

The law allows a competent adult to refuse medical treatment without reason or justification.

Blood products

Religious groups such as Jehovah’s Witnesses may refuse all blood products and it is essential that such wishes are very carefully documented. In cases where advanced refusal of blood products is known and the potential for bleeding anticipated (e.g. laparoscopy for ectopic pregnancy) the most senior person available should perform the procedure.

Caesarean section

Several cases have been brought to court challenging a woman’s right to refuse a CS thought by doctors to be in the best interests of her or her fetus.

The law is clear that the fetus in utero has no legal rights up until the moment of birth. Therefore, a woman may refuse to consent to CS even if the consequences for herself or the fetus are death or severe injury.

Subfertility

The Human Fertilization and Embryology Authority (HFEA) Act 1990 regulates the area of reproductive medicine covering:

•Infertility treatments using donated genetic material.

•Infertility treatments involving stored genetic material.

•The creation of embryos outside the body.

•Embryo research.

The Act established the HFEA. This body licenses, monitors, and reports on establishments that provide fertility treatments. Individuals undergoing fertility treatments covered by the Act must give written consent to treatment as well as to storage of gametes and embryos. When couples have fertility treatment together, both must consent to the treatment and either may withdraw their consent at any time.

Consent in children

It is not uncommon for child <16yrs to request contraception or a TOP without parental knowledge. In the case of Gillick vs. West Norfolk and Wisbech AHA (1985), the courts ruled that doctors may treat children without parental consent if certain conditions are fulfilled:

•The child understands the advice or treatment being given.

•Attempt has been made to persuade the child to inform the parents.

•In case of seeking contraception, the child is likely to have unprotected intercourse whether or not contraception is prescribed.

•The physical or mental health of the child is likely to suffer if the treatment is not provided.

CONSENT FOR COMMON GYNAECOLOGICAL PROCEDURES 785

Some practical tips on consent

•If you are the surgeon, consent the patient personally, do not delegate the responsibility unless unavoidable.

•If consent has already occurred, but there is a significant time gap (more than 1mth) then check it is still clinically appropriate and consider reconsent for the procedure.

•If you do not document what you have discussed it didn’t occur!

•‘Risks of procedure fully discussed’ is not adequate—you need to be procedure specific including realistic possible outcomes.

•Even if a patient’s decisions about her procedure seem inappropriate they are her right to make—if you feel uncomfortable about

a patient’s decision or are feeling manipulated into performing something you do not feel is appropriate then do not do the procedure!—get a second opinion.

•Always record their LMP and current method of contraception in the reproductive age group.

•If there is even a remote chance the patient may be pregnant (especially in the luteal phase) then it is better to postpone the procedure—the commonest reason for a pregnancy post-sterilization is that the patient was pregnant at the time of the procedure!

If you are in any doubt about the appropriateness of surgery, the patient’s decision, or unexpected anaesthetic issues on the day (e.g. temperature or unexpected low Hb) at the time of consent, then it is generally better to postpone the operation—if something adverse occurs, the first question will always be ‘did she need an operation at all or on that day?’

Further reading

RCOG. (2008). Obtaining valid consent. Clinical Governance Advice 6. M http://www.rcog.org.uk/ womens-health/clinical-guidance/obtaining-valid-consent

CONSENT FOR SURGERY THAT BREACHES THE PERITONEUM 787

Consent issues specific to laparoscopic sterilization

The following are mandatory for anyone requesting sterilization:

•Absolute certainty that their family is complete.

•The irreversible nature of sterilization.

•A recognized failure rate of 1:200.

•That male sterilization is a less risky procedure, done under LA, and has a failure rate of 1:2000 after two negative semen analyses.

•There has been a full consideration of all long-acting reversible contraceptives (LARCs), e.g. IUCD, Mirena®, implants.

1Current recommendations are that sterilization should almost never be considered in patients <30yrs as later regret is common. A second opinion, at minimum, is good practice in these circumstances.

Further reading

RCOG. (2008). Obtaining valid consent. Clinical Governance Advice 6. M http://www.rcog.org.uk/ womens-health/clinical-guidance/obtaining-valid-consent

788 CHAPTER 24 Miscellaneous gynaecology

Consent for surgery that enters the uterine cavity

Procedures involving entry to the uterine cavity include hysteroscopy, evacuation, and TOP procedures.

•Primary purpose of procedure, e.g. diagnostic/therapeutic/both.

•What if anything will be removed, including making the patient aware this may change depending upon intraoperative findings, e.g. hysteroscopy +/– endometrial biopsy +/– resection of polyp +/– fibroid resection.

•Specifically consent for operative resection if this is a realistic possibility.

•Risks of all intrauterine procedures: haemorrhage/infection (endometritis)/small risk of uterine perforation with a small risk of injury to bowel, bladder, ureters, major blood vessels.

•Specifically for ERPC/TOP procedures the small risk of incomplete evacuation.

•Risks of intra-abdominal injury increase when operative resection and/ or other energy sources are used.

•Small risk of the need for laparoscopy +/– laparotomy and repair in the event of uterine perforation.

Endometrial ablation procedures

In addition to the above issues the following are mandatory for anyone requesting endometrial ablation:

•Absolute certainty that their family is complete.

•The continued need for contraception post procedure.

•The possibility (procedure type dependent) of amenorrhoea.

•The possibility of the need for a second procedure in the next 5yrs.

Further reading

RCOG. (2008). Obtaining valid consent. Clinical Governance Advice 6. M http://www.rcog.org.uk/ womens-health/clinical-guidance/obtaining-valid-consent

CONSIDERATIONS FOR PREOPERATIVE ASSESSMENT 789

Considerations for preoperative assessment in gynaecology

Preoperative assessment has all of the same general considerations as for all other surgical procedures—the majority of procedures are now done in day surgery. In terms of specific considerations they are procedure specific, but consider the following.

Specific gynaecological issues

•All women in the reproductive age are pregnant till proven otherwise—ensure that contraception and last normal menstrual period (LNMP) are clearly sought and documented in clinic and again immediately preoperatively (see bConsent to treatment, p. 782).

•The above is especially true in those having surgery for fertility reasons—a preoperative pregnancy test is mandatory, but also beware unprotected sex in the cycle of the procedure—her pregnancy test may not be positive yet!

•If there is any doubt regarding possible pregnancy or the viability of a pregnancy prior to ERPC then do not continue until your doubts have been answered.

•NEVER assume a woman’s future reproductive wishes—always ask them and document them.

•Do not operate on a pregnant women unless that is the indication for surgery (e.g. ERPC) or the benefits outweigh the risks.

•Do not forget anti-D administration for all Rh –ve women who have a uterine evacuation procedure or surgery for ectopic pregnancy.

•Where the uterine cavity is instrumented consider chlamydial prophylaxis to prevent ascending infection unless the patient has been screened recently and is –ve—the default position is to give it!

•Many of the women will de facto have risk factors for VTE, e.g. pregnancy, pelvic surgery, COCP use. All need a WHO VTE assessment.

•Woman having intraperitoneal surgery need consideration for bowel preparation if: multiple previous abdominal surgery, endometriosis, known adhesions, cancer.

•The need for specific preoperative investigations (e.g. ECG, CXR) is otherwise similar to general surgery, though nearly all will require an FBC and Group + Save at minimum.

•The majority of women will require ultrasound (or more rarely other imaging, e.g. CT/MRI) as part of their clinical pathway to provide information regarding their procedure—Ask yourself: ‘Has this patient had an ultrasound?’, and if not, ‘does she need one?’

790 CHAPTER 24 Miscellaneous gynaecology

Clinical risk management: identifying and analysing risks

Clinical risk management is a mechanism for improving the quality of patient care. There are several steps in the process.

Identifying risk

What went wrong or what could go wrong

There are local and national sources used to identify risk issues outlined in the opposite box

Completing an incident reporting form

Most trusts have a dedicated reporting form to complete. These should be available in all clinical areas. All members of staff of all grades should be encouraged to complete forms when they are aware of risk incidents. A form should be completed for all actual adverse incidents affecting patients, as well as near misses.

Many units have a list of specific risk triggers that should prompt completion of a risk form. These might include an unplanned return to theatre, cord pH <7.10, or an operative blood loss of more than 800mL.

Serious incidents must be reported immediately to the local lead for clinical risk. All hospitals will have definitions for what constitutes such a serious untoward incident. When a serious incident has occurred, all staff concerned should prepare contemporaneous statements of their involvement whilst the incident is still fresh in their mind.

When writing incident reports and statements, only an account of the facts should be documented, not an opinion of what went wrong.

Incident form information

•Full patient details.

•Date, time, and location of incident.

•All staff involved (statements may be requested at a later date).

•Brief factual report of the incident.

Risk analysis

Root cause analysis is a structured investigation that aims to identify the true cause of a problem and the actions necessary to eliminate it.

Adverse incidents rarely occur as a result of individual error alone. Factors contributing to the incident should be identified and an analysis report submitted.

CLINICAL RISK MANAGEMENT: IDENTIFYING AND ANALYSING RISKS 791

Possible sources of risk identification

Local sources for identifying risk

•Incident report forms.

•Patient complaints.

•Audit results.

National sources for identifying risk

•NPSA alerts.

•Reports of national confidential enquiries.

•Care Quality Commission.

Possible contributory factors to a risk incident

•The patient.

•Individual staff.

•Communication.

•Team working (or not).

•Education and training of staff.

•Equipment and resources.

•Working conditions.

Risk analysis report

Will contain:

•Obvious outcomes that occurred.

•The chronology of events.

•The care management problems identified.

•A list of contributing factors.

•Recommended actions required.

•A timetable for implementation of recommendations.

792 CHAPTER 24 Miscellaneous gynaecology

Clinical risk management: risk reduction

Risk reduction

May be achieved by:

•Training.

•Introduction of guidelines.

•Increasing resources.

Risk elimination

May mean ceasing to provide a particular service.

Acceptance of risk

There is an acceptance that some risk cannot be reduced or eliminated. Hospitals attempt to keep litigation costs to a minimum by joining the Clinical Negligence Scheme for Trusts (CNST—see Box 24.1).

Dissemination of lessons learned

•Local level: sharing information with other units in the hospital.

•National level: through bodies such as the NPSA and Royal Colleges.

•Sharing information should include good practice points.

What risk management is not!

•‘Big brother.’

•A vehicle for individual blame or recrimination.

•An audit or research tool.

•A management policing policy (it is for everyone to learn from).

•Only designed to highlight bad care (good care should also be commended and fed back to staff, even if the outcome is poor or risk has occurred).

•A legal or negligence body.

CLINICAL RISK MANAGEMENT: RISK REDUCTION 793

Box 24.1 The Clinical Negligence Scheme for Trusts

•The CNST handles clinical negligence claims against member NHS bodies.

•Membership is voluntary, but currently all NHS and primary care trusts in England belong.

•The costs of the scheme are met by membership contributions:

•the total projected claims cost are assessed in advance each year and contributions are determined for each trust (influenced by a range of factors including type of trust and specialties it provides)

•discounts are available to trusts that achieve the relevant NHSLA risk management standards and to those with a good claims history.

When a claim is made against a member of the CNST, the body remains the legal defendant, but the NHSLA is responsible for handling the claim and associated costs.

GYNAECOLOGICAL IMAGING I 795

Postmenopausal bleeding

Approximately 10% of women with PMB will have gynaecological cancer, most of which is endometrial cancer.

A TVS examination with measurement of ET can discriminate between women at high and low risk.

Using a cut-off of an ET of 4mm:

•96% of endometrial carcinomas can be identified using TVS.

•Endometrial cancer and hyperplasia can be suspected on TVS, but need a biopsy to confirm them histologically.

•If the ET is <4mm it is extremely unlikely that the woman has endometrial cancer—<1% (very high negative predictive value).

•Up to 55% of women with no disease will also have a positive result (much lower positive predictive value).

•Polyps may also be picked up as focal entities.

•Incidental ET measurements >4mm do not generally need further investigation in the absence of PMB.

•These ET measurements, in women before they are officially menopausal, cannot be used as their ET will vary depending upon cyclical activity.

Although the –ve predictive value is high for ET <4mm, in the presence of recurrent PMB the patient should have hysteroscopy.

Other methods for assessing the endometrium

•Saline infusion sonography:

•infusion of saline into uterine cavity during scanning

•allows assessment of focal endometrial lesions

•agreement between saline infusion sonography and hysteroscopy is excellent.

•MRI may be indicated in the presence of fibroids if hysteroscopy is unhelpful.

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Gynaecological imaging II

Pelvic pain

Acute pelvic pain

•USS is the diagnostic imaging method of choice.

•The following can reliably be diagnosed on TVS:

•ovarian cysts

•some sequelae of PID (including pyosalpinx and tubo-ovarian abscess)

•hyrdosalpinges

•fibroid degeneration.

2 Colour Doppler may aid in adnexal torsion, but the findings are not specific enough and the diagnosis is usually made on clinical findings.

2 Haemorrhagic ovarian cysts and ruptured ovarian cyst accidents have typical appearances on TVS.

Chronic pelvic pain

•Endometriosis may be diagnosed by the finding of endometriomas and occasionally by the visualization of endometriotic nodules elsewhere in the pelvis such as the rectovaginal septum, although these may be better visualized with MRI or rectal USS.

•Adenomyosis is associated with a thickening of the myometrium, uterine asymmetry, and with areas of both dand iechogenicity.

•The diagnostic accuracy of imaging to assess pelvic adhesions is uncertain.

•‘Soft markers’ including immobile ovaries, site-specific tenderness, and loculated pelvic fluid may indicate pathology confirmed by laparoscopy.

Subfertility

USS is used in both the diagnosis and the management of infertility. It can be used to diagnose conditions such as polycystic ovarian disease and hydrosalpinx and to track follicular growth and rupture during normal and stimulated cycles during infertility treatment.

•Oocyte retrieval for assisted conception techniques is performed under USS guidance.

•Complications such OHSS can also be assessed by USS.

•HSG using radio-opaque dye and image intensification used to be the imaging method of choice to assess the uterine cavity and fallopian tubes:

•has now been superseded by hysterosalpingo-contrast-sonography (HyCoSy) where a solution is infused into the uterine cavity whilst performing a TVS

•combines a baseline TVS, assessment of the fallopian tubes and possibly even ovulation if the investigation is correctly timed.

•TVS is used to confirm viable or non-viable intrauterine pregnancy and indeed ectopic pregnancy as a result of IVF or other assisted

reproduction techniques.