In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.
Levels of evidence (1a-4) and grading of recommendations (A-C) are defined at the end of the Major Recommendations field.
General
Indications for or Against Sterilization
C - If there is any question of a person not having the mental capacity to consent to a procedure that will permanently remove their fertility, the case should be referred to the courts for judgment.
C - Additional care must be taken when counselling people under 30 years of age or people without children who request sterilisation.
What is Required Before the Procedure is Performed?
C - All verbal counselling advice must be supported by accurate, impartial printed or recorded information (in translation, where appropriate and possible), which the person requesting sterilisation may take away and read before the operation.
C - Counselling and advice on sterilisation procedures should be provided to women and men within the context of a service providing a full range of information about and access to other long-term reversible methods of contraception. This should include information on the advantages, disadvantages, and relative failure rates of each method.
C - Both vasectomy and tubal occlusion should be discussed with all men and women requesting sterilisation.
B - Women in particular should be informed that vasectomy carries a lower failure rate in terms of post-procedure pregnancies and that there is less risk related to the procedure.
C - A history should be taken and an examination should be performed on all men and women requesting vasectomy or tubal occlusion.
C - The operating doctor will need to ensure that the counselling, information exchange, history, and examination have been completed and be satisfied that the patient does not suffer from concurrent conditions which may require an additional or alternative procedure or precaution.
Tubal Occlusion
Methods
A - Culdoscopy should not be used as a method of approach for sterilisation.
A - Where equipment and trained staff are available, the laparoscopic approach to the fallopian tubes is quicker and results in less minor morbidity compared with mini-laparotomy.
B - Any effective surgical or mechanical method of tubal occlusion can be used when a mini-laparotomy is used as the method of approach for an interval sterilisation.
B - A modified Pomeroy procedure rather than Filshie clip application may be preferable for postpartum sterilisation performed by mini-laparotomy or at the time of caesarean section, as this leads to lower failure rates.
A - Mechanical occlusion of the tubes by either Filshie clips or rings should be the method of choice for laparoscopic tubal occlusion.
C - The routine use of more than one Filshie clip is not recommended.
C - Diathermy should not be used as the primary method of tubal occlusion because it increases the risk of subsequent ectopic pregnancy and is less easy to reverse than mechanical occlusive methods.
C - Hysteroscopic methods of tubal occlusion are still under evaluation and should only be used within the present guidance system for new surgical interventions.
Information
B - Women, particularly those at increased risk from conditions such as previous abdominal surgery or obesity, should be informed of the risks of laparoscopy and the chances of laparotomy being necessary if there are problems with laparoscopy.
Anaesthesia
A - While recognising that general anaesthesia is usually used in the United Kingdom (UK) for laparoscopic tubal occlusion, local anaesthesia is an acceptable alternative.
C - Laparoscopic tubal occlusion should be performed as a day case wherever possible.
A - Topical application of local anaesthesia to the fallopian tubes should be used whenever mechanical occlusive devices are being applied either under general or local anaesthesia.
Failure
B - Women should be informed that tubal occlusion is associated with a failure rate and that pregnancy can occur several years after the procedure. The lifetime risk of failure in general is estimated to be one in 200. The longest period of follow-up data available for the most common method used in the UK, the Filshie clip, suggests a failure rate after ten years of two to three per 1,000 procedures.
B - Women should be informed that, if tubal occlusion fails, the resulting pregnancy may be ectopic.
Timing
B - Tubal occlusion should be performed after an appropriate interval following pregnancy wherever possible. Should tubal occlusion be requested in association with pregnancy (either postpartum or post-abortion), the woman should be made aware of the increased regret rate and the possible increased failure rate.
C - If tubal occlusion is to be performed at the same time as a caesarean section, counselling and agreement should have been given at least one week prior to the procedure.
B - Tubal occlusion can be performed at any time during the menstrual cycle, provided that the clinician is confident that the woman has used effective contraception up to the day of the operation. If this is not the case, the operation should be deferred until the follicular phase of a subsequent cycle. The woman should be advised to continue to use effective contraception until her next menstrual period.
B - A pregnancy test must be performed before the operation to exclude the possibility of a preexisting pregnancy. However, a negative test does not exclude the possibility of a luteal-phase pregnancy.
B - Routine curettage at the time of tubal occlusion, in order to prevent a luteal-phase pregnancy, is not recommended.
Reversal
B - Although women requesting sterilisation should understand that the procedure is intended to be permanent, they should be given information about the success rates associated with reversal, should this procedure be necessary.
Risks
B - Women should be reassured that tubal occlusion is not associated with an increased risk of heavier or irregular periods when performed after 30 years of age. There is an association with subsequent increased hysterectomy rate, although there is no evidence that tubal occlusion leads to problems that require a hysterectomy. Data are limited on the effect on menstruation when tubal occlusion is performed on women under 30 years of age.
Training
C - Trainees should perform at least 25 supervised laparoscopic tubal occlusions before operating without supervision.
Vasectomy
Methods
A - Except when technical considerations dictate otherwise, a no-scalpel approach should be used to identify the vas, as this results in a lower rate of early complications.
A - Division of the vas on its own is not an acceptable technique because of its failure rate. It should be accompanied by fascial interposition or diathermy.
B - Clips should not be used for occluding the vas, as failure rates are unacceptably high.
Anaesthesia
C - Vasectomy should be performed under local anaesthetic wherever possible.
Histological Examination
C - Excised portions of vas should only be sent for histological examination if there is any doubt about their identity.
Post-Vasectomy Semen Analysis
C - Men should be advised to use effective contraception until azoospermia has been confirmed. The way in which azoospermia is confirmed will depend upon local protocols.
A - Irrigation of the vas during vasectomy does not reduce failure rates or time to clearance.
Special Clearance
C - In a small minority of men, non-motile sperm persist after vasectomy. In such cases, "special clearance" to stop contraception may be given when less than 10, 000 non-motile sperm/milliliter (mL) are found in a fresh specimen examined at least seven months after vasectomy, as no pregnancies have yet been reported under these circumstances.
Failure
B - Men should be informed that vasectomy has an associated failure rate and that pregnancies can occur several years after vasectomy. The rate should be quoted as approximately one in 2,000 after clearance has been given.
Reversal
B - Although men requesting vasectomy should understand that the procedure is intended to be permanent, they should be given information on the success rates associated with reversal, should this procedure be necessary.
Risks
B - Men requesting vasectomy can be reassured that there is no increase in testicular cancer or heart disease associated with vasectomy. The association, in some reports, of an increased risk of being diagnosed with prostate cancer is at present considered likely to be noncausative.
B - Men should be informed about the possibility of chronic testicular pain after vasectomy.
Training
C - Practitioners who are being trained to perform vasectomies should ensure that their training conforms to that advocated by the Faculty of Family Planning and Reproductive Health Care. Doctors with no prior experience should be supervised for ten operating sessions or 40 procedures, while doctors with relevant prior surgical experience should perform eight supervised procedures.
Audit
C - A national register and audit of failed sterilisations is needed. Hospital-based registers of sterilisation procedure failures would assist this.
Definitions:
Levels of Evidence
1a: Evidence obtained from systematic review of meta-analysis of randomised controlled trials
1b: Evidence obtained from at least one randomised controlled trial
2a: Evidence obtained from at least one well-designed controlled study without randomisation
2b: Evidence obtained from at least one other type of well-designed quasi-experimental study
3: Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies
4: Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities
Grading of Recommendations:
Grade A - Requires at least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation (evidence levels 1a, 1b)
Grade B - Requires the availability of well-conducted clinical studies but no randomised clinical trials on the topic of the recommendation (evidence levels 2a, 2b, 3)
Grade C - Requires evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates an absence of directly applicable clinical studies of good quality (evidence level 4)
