Falloposcopy with coaxial catheter

# Guidance
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 actions.
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.# The procedure

# Indications
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, 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.

# Outline of the procedure
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 a fallopian tube. The surgeon then passes an 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.

# Efficacy
No controlled studies were found, and none of the studies identified were of high quality. Some studies were on the investigative use of falloposcopy with coaxial catheter 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 women 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 procedure's therapeutic use found coaxial 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 falloposcopy with coaxial catheter (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 women who underwent falloposcopy with coaxial catheter.
One comparative study on the consistency between the results of hysterosalpingography and falloposcopy was identified. In this study, only 15% (3/20) of tubes found to be blocked when using hysterosalpingography were found to be blocked when using falloposcopy. However, no 'gold standard' test was available to determine the validity of the results. For more details, refer to the 'Sources of evidence' section.
One Specialist Advisor noted that the images obtained by falloposcopy with coaxial catheter were often of poor quality and the 'normal' internal appearance of the tube was not clearly defined.

# Safety
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 during 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 women had undergone falloposcopy with coaxial catheter. For more details, refer to the 'Sources of evidence' section.
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.

# Other comments
This is one of a number of techniques for examining the fallopian tubes, but it is seldom used in the UK.
Andrew DillonChief ExecutiveJune 2004# Further information

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.
'Interventional procedure overview of falloposcopy with coaxial catheter', November 2002.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# Changes since publication
As part of the NICE's work programme, the current guidance was considered for review but did not meet the review criteria as set out in the IP process guide. This guidance therefore remains current.
January 2012: minor maintenance.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2004. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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