The National Institute for Clinical Excellence is examining falloposcopy with coaxial catheter and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about falloposcopy with coaxial catheter.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 24 February 2004

Target date for publication of guidance: May 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of falloposcopy with coaxial catheter does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake falloposcopy with coaxial catheter should take the following action.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's Information for the Public is recommended.
• Audit and review clinical outcomes of all patients having falloposcopy with coaxial catheter. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence

Falloposcopy with coaxial catheter is used to investigate and treat subfertility in women.

Conventional investigation of subfertility in women often includes examination of the fallopian tubes using hysterosalpingography (an X-ray test), or laparoscopy with dye injection to check the patency of the fallopian tubes. Occasionally salpingoscopy is performed: this involves inspection of the inside of the fallopian tubes from the outer fimbrial end, during laparoscopy or laparotomy.

Falloposcopy with coaxial catheter is a technique for direct inspection of the inside of the fallopian tubes via the cervix and uterus. The coaxial technique involves inserting a narrow catheter over a guidewire through the cervix and uterine cavity into the fallopian tubes. The surgeon then passes a flexible endoscope through the catheter. Unlike X-ray methods or laparoscopy, falloposcopy allows balloon dilatation to be performed on obstructive lesions at the time of the procedure.

No controlled studies were found, and none of the studies identified were of high quality. Some studies were on the use of falloposcopy with coaxial catheter as an investigation and others looked at the procedure as a therapeutic technique.

Among the studies on investigation, the rate of successful fallopian tube cannulation/catheterisation ranged from 83% (30/36) to 85% (110/130). In two studies, the failure rate of falloposcopy was 11% (9/84 and 8/71), but some patients may have been included in both studies. Successful imaging or 'correct' visualisation of the fallopian tube ranged from 30% (33/110) to 88% (28/32)

One of the studies on the therapeutic use of falloposcopy found falloposcopy with direct balloon tuboplasty to be successful in treating endotubal lesions in 41% (13/32) of tubes. Another study reported 96% (52/54) of recanalisations to be technically successful, but of the tubes successfully recanalised only 31% (16/52) were as a result of coaxial falloposcopy (the other 36 were treated by selective salpingography). Five pregnancies occurred in this study, but it was not possible to determine whether these occurred in patients who underwent coaxial falloposcopy.

One comparative study on the consistency between hysteropsalpingography and falloposcopy results was identified. In this study, only 15% (3/20) of tubes found to be blocked on hysteropsalpingography were found to be blocked on falloposcopy. However, no 'gold standard' test was used to determine the validity of the results. For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor noted that the images obtained by falloposcopy with coaxial cable were often of poor quality and the 'normal' internal appearance of the tube was not clearly defined.

In the studies identified, the main complications reported were: tubal perforation, which occurred in 1% (1/130) to 4% (3/67) of tubes; and uterine perforation, which occurred in procedures on 2% (3/130) of tubes. One study reported a complication rate of 23% (3/13) for distal fallopian tube obstructions, but it was not clear whether these patients had undergone coaxial falloposcopy. For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor considered the main potential adverse effect of this procedure to be perforation of the fallopian tube; this is usually a minor complication.

This is one of a number of techniques for examining the fallopian tubes, but is seldom used in the UK.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional Procedure Overview of falloposcopy with coaxial catheter November 2002

Available from: www.nice.org.uk/ip032overview