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This paper provides advice for clinicians in obtaining consent of women undergoing Laparoscopic Tubal Occlusion. It follows the structure of the Department of Health/Welsh Assembly Government Consent Form 1 and should be used in conjunction with RCOG Clinical Governance Advice No. 6: Obtaining valid consent. Its aim is to ensure that all patients are given consistent and adequate information for consent; it is intended to be used together with dedicated patient information. Clinicians should be prepared to discuss any of the following fully with the patient.
1. Name of proposed procedure or course of treatment
Laparoscopic tubal occlusion (sterilisation for women).
2. The proposed procedure
The fallopian tubes will be blocked or cut. Explain the procedure as described in the patient information.
3. Intended benefits
This procedure intends to permanently prevent pregnancy.
4. Serious or frequently occurring risks
It is recommended that clinicians make every effort to separate serious from frequently occurring risks. Women who are obese, have had previous surgery or who have pre-existing medical conditions must understand that the quoted risks for serious or frequent complications will be increased.
4.1 Serious risks include
- Failure, resulting in unplanned pregnancy: the lifetime failure rate is 1 in 200. 1
- The possibility of a future pregnancy occurring in the fallopian tube if failure occurs.
- Failure to gain entry to the abdomen.
- Uterine perforation.
- Injuries to the bowel, bladder or blood vessels are serious but infrequent risks: 3 in every 1000 procedures. 1
- One woman in every 12 000 undergoing laparoscopy dies as a result of complications1 (more recent evidence suggests that the mortality rate may be lower). 2
4.2 Frequent risks include
- Bruising
- Shoulder-tip pain.
5. Any extra procedures which may become necessary during the procedure
- Laparotomy.
- Repair of damage to bowel, bladder or blood vessels.
6. What the procedure is likely to involve, the benefits and risks of any available alternative treatments, including no treatment
A small telescope is put into the abdomen through two small cuts (one in the navel and one lower down on the abdominal wall) and clips are placed over the fallopian tubes to block them (or describe other method of tubal occlusion). Other therapies such as vasectomy of partner and reversible longterm contraception such as the intrauterine system, the intrauterine device or an implant must be discussed, together with the option of no treatment.
7. Information leaflet/tape
A record should be made of the information leaflet/tape given to the woman prior to surgery.
8. Anaesthesia
The woman must be aware of the form of anaesthesia planned and be given an opportunity to discuss this in detail with the anaesthetist before surgery.
9. Statement of patient: procedures which should not be carried out without further discussion
Other procedures which may be appropriate but not essential at the time should be discussed and the woman's wishes recorded.
References
- Royal College of Obstetricians and Gynaecologists. Male and Female Sterilisation . National evidence-based guideline No. 4. London: RCOG Press; 2004.
- Chapron C, Querleu D, Bruhat M, Madelenat P, Fernandez H, Pierre F, at el. Surgical complications of diagnostic and operative gynaecological laparoscopy: a series of 29,966 cases. Hum Reprod 1998; 13(4):867–72.
Valid until October 2006 unless otherwise indicated
