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How well do we counsel women prior to laparoscopic procedures?Khaund A, Jamieson R

South and North Glasgow University Hospitals, Greater Glasgow and Clyde, Scotland, UK.

IntroductionApproximately 250,000 women undergo laparoscopic surgery each year. Whilst majority are performed without problems, serious and minor complications may occur. Women should not only be aware of the indications, nature and alternatives to their surgery pre-operatively, but should also be fully informed of the associated risks. The latter is facilitated by informed consent which is bound by medical, legal, ethical and psychological considerations.

It is no longer acceptable to simply complete and sign a consent form. When obtaining consent, precise and legible documentation of the discussion pertaining to the procedure and its risks, is essential. This not only reduces the incidence of litigation, but improves satisfaction for both women and their doctors.It is vital therefore that women are counselled appropriately before laparoscopic procedures.

AimsIn order to improve our method of consent, we audited out current practices when obtaining consent before laparoscopic surgery and compared them to the standards set by the Royal College of Obstetricians and Gynaecologists (RCOG).

MethodsRetrospective casenote review of 50 women who underwent diagnostic laparoscopy as daycases in Greater Glasgow between March and September 2010. Patients were identified from the Daysurgery Theatre Register and case notes retrieved thereafter. A record was made of whether there was evidence of documentation of the risks associated with the procedure either in the gynaecology section of the written case notes, within a dictated letter to the GP or on the consent form itself. Risks discussed with the women were divided into visceral damage (bowel, bladder and major blood vessel damage), the potential need for laparotomy, haemorrhage +/- blood transfusion and infection. Documentation of all the latter points constituted discussion of “all risks.” A note was also made of the grade of doctor obtaining consent.

DiscussionIt is interesting to note that majority of women were consented by a Consultant prior to their surgery. In the current NHS where a Consultant led service is being promoted, this is encouraging. Nonetheless, there is no reason why a trainee experienced in a particular procedure cannot obtain consent preoperatively. Whilst more than half of consultants and middle grade doctors documented all risks associated with laparoscopy in full, this study demonstrates that middle-grade doctors are in fact better at doing this when compared to their senior colleagues (81% versus 52%). All grades of doctor provided some degree of counselling to women, but 53% of Consultants and 19% of trainees documented only some of the specific risks associated with laparoscopy, thus not complying with RCOG standards.When obtaining consent, thorough preoperative counselling and documentation is time consuming, especially during a busy clinic. The provision of a standardised consent form as suggested by the RCOG would not only reduce the time spent documenting the consent discussion, but also ensure that women are given consistent, precise and adequate information by all doctors obtaining consent. The utility of a standardised proforma when obtaining consent for women undergoing Laparoscopic Sterilisation has proven to work well in Greater Glasgow. Provision of a standardised consent form for all women undergoing all laparoscopic procedures, whether diagnostic or operative, would allow better time management in clinic and ensure that all aspects of risk are covered.Below (Figure 2) is an example of a standardised consent form. It is a modified version of that recommended by the RCOG. A copy of the consent form could be given to the woman, along with a patient information leaflet pertaining to the specific procedure.

References

ConclusionThis study demonstrates the lack of consistency and inadequacy which occurs when obtaining consent before laparoscopy. It also demonstrates the need for improvement in the way in which we counsel and consent women before surgery. The introduction of a standardised consent form would facilitate the latter. If proven to be effective, standardised consent forms for abdominal and vaginal surgery, such as those suggested by the RCOG, could subsequently be introduced.

Figure 2

OPTIONALLOGO HERE

OPTIONALLOGO HERE

Royal College of Obstetricians and Gynaecologists. Obtaining Valid Consent. Clinical Governance Advice No.6: Royal College of Obstetricians and Gynaecologists; 2004 (www.rcog.org.uk/resources/public/pdf/CGA_No6.pdf).

Fidelhma O’Mahony, Loannis Koutoukos, Vijay Menon. Risk Management. What should we tell women preoperatively? The Obstetrician and Gynaecologist. 2006; 8: 165-169.

Royal College of Obstetricians and Gynaecologists. Preventing Entry-related Gynaecological Laparoscopic Injuries. Green-top Guideline No. 49. London: Royal College of Obstetricians and Gynaecologists; 2008 (www.rcog.org.uk/womens-health/clinical-guidance/preventing-entry-related-gynaecological-laparoscopic-injuries-green).

Royal College of Obstetricians and Gynaecologists. Gynaecological surgery Consent Advice Nos. 2 - 5; 2004 (www.rcog.org.uk/resources/public).

Name of proposed laparoscopic procedure: Patient identifier/label ............................................................................. Statement of health professional: □ I have explained the procedure to the patient (including the need for vaginal examination and bladder catheterisation) I have also explained: □ The intended benefits of surgery □ Serious risks: ● The overall risk of serious complications from diagnostic laparoscopy is approximately 2 women in every 1000 (uncommon) ● Damage may occur to the bowel, bladder, uterus or major blood vessels which would require immediate repair by laparoscopy or laparotomy (uncommon). Up to 15% of bowel injuries might not be diagnosed at the time of laparoscopy and may require a laparotomy >24hours after the initial laparoscopic procedure ● 3–8 women in every 100 000 undergoing laparoscopy die as a result of complications (very rare) □ Other risks: ● Failure to gain entry to the abdominal cavity and to complete the intended procedure. An immediate laparotomy or rescheduled procedure may be required in such situations ● Bruising / haematoma formation ● Shoulder-tip pain ● Wound infection ● Wound gaping ● Hernia at site of port entry ● Urinary tract infection (from bladder catheter use) ● Anaesthesia ● Blood transfusion This procedure will involve: □ General and/or regional anaesthesia □ Local anaesthesia □ Sedation

Signed (DOCTOR) .....................................................Date……………………....... Name (PRINT) .....................................................................J ob Title………………........ Signed (PATIENT) ………………………………………………Date ……………………….. Name (PRINT) ………………………………………………….. Statement of interpreter (where appropriate) I have interpreted the information above to the patient to the best of my ability in a way in which I believe she can understand Signed ...................................................................................Date..................................... Name (PRINT)……………………………………………………. Top copy accepted by patient: yes/no (please ring)

ResultsFifty women underwent diagnostic laparoscopy. All signed a consent form prior to their procedure, 42 (84%) of which were filed in the case notes.

Twenty three (46%) and 16 (32%) women were consented by the Consultant and middle-grade trainee, respectively.

Of the 23 (46%) consultant consent discussions, only 1 (4%) and 12 (52%) included documentation of all risks in the case notes and on the consent form, respectively. One (4%) and 4 (17%) included discussion of bowel damage, bladder damage and laparotomy in the case notes and GP letter, respectively. The remaining 5 (22%) dictated “risks discussed” in the GP letter, but as such, did not state specific risks (Figure 1).

Of the 16 (32%) middle grade discussions, 13 (81%) included documentation of all risks on the consent form, 1 (6%) included discussion of bowel damage, bladder damage and laparotomy in the GP letter and 2 (13%) stated “risks discussed” in the GP letter, although these were not specifically defined (Figure 1).

Figure 1.

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Documentation of all risks Visceral damage /laparotomy discussed

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