Laparoscopic uterine nerve ablation: a survey of gynaecological practice in the UK

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q 2000 Blackwell Science Ltd Gynaecological Endoscopy 2000 9, 157–159 157 Laparoscopic uterine nerve ablation: a survey of gynaecological practice in the UK Jane Daniels, 1 Richard Gray, 1 Khalid S. Khan 2 and Janesh K. Gupta 2 1 Clinical Trials Unit, University of Birmingham, UK 2 Department of Obstetrics and Gynaecology, University of Birmingham, UK ABSTRACT Objective To determine the current use of and the indications for laparo- scopic uterine nerve ablation (LUNA) in the UK, and to establish practi- tioners’ views regarding the desirability of a controlled clinical trial to assess the efficacy of LUNA. Setting Gynaecologists associated with the British Society of Gynecological Endoscopy. Design A self-administered structured questionnaire was posted to 457 UK gynaecologists. Their surgical practice and willingness to participate in a randomized trial were surveyed. The postal questionnaire was returned by 249 (55% response rate). Results The survey indicated that 113 (45%) of the responders per- formed LUNA. Of these, 86 (76%) carried out LUNA for chronic pelvic pain, 72 (64%) for endometriosis, and 16 (14%) for dyspaurenia/dysme- norrhoea. Diathermy was used as the surgical tool by 66 (59%) gynae- cologists and laser was used by 57 (51%). Of the 113 currently using LUNA, 91 (81%) were willing to enter patients into a proposed clinical trial of LUNA. Conclusion Current clinical practice regarding LUNA for pelvic pain is hung in equipoise. This means that the technique has been introduced without reliable evidence of efficacy but opinion regarding its use is not yet solidified. Hence, a rigorous randomized trial of LUNA’s efficacy is urgently needed and is practicable. Keywords laparoscopic uterine nerve ablation (LUNA), questionnaire. Correspondence K. S. Khan, Academic Department of Obstetrics and Gynaecology, Birmingham Women’s Healthcare NHS Trust, Birmingham B15 2TG, UK. Accepted for publication 29 July 1999 INTRODUCTION Chronic pelvic pain, defined as constant or intermit- tent, cyclic or acyclic pelvic pain that persists for 6 months or more, 1 has a major impact on health-related quality of life, work productivity and health care utili- zation, costing an estimated 158 million pounds per year in the UK. 2 Dysmenorrhoea, deep dyspareunia and intermenstrual pain constitute the main symptom complex in chronic pelvic pain, which frequently leads to surgical interventions including laparoscopy. 3,4 With recent developments in minimal access surgery, laparoscopic uterosacral nerve ablation (LUNA) is a practicable treatment option at the time of diagnostic laparoscopy in chronic pelvic pain. 4 By interrupting pain pathways in the nerve plexuses and ganglia of the uterosacral ligaments LUNA is expected to alleviate pelvic pain. 5,6 However, the therapeutic role of this intervention has not been adequately assessed by rigorous clinical research. 7 Despite the lack of definitive evidence, many gynaecologists familiar with the operative technique offer LUNA as a therapeutic option to their patients with pelvic pain. This discrepancy between evidence and practice induced us to examine current surgical practices regarding LUNA and to determine practi- tioners’ willingness to participate in a clinical trial of LUNA.

Transcript of Laparoscopic uterine nerve ablation: a survey of gynaecological practice in the UK

Page 1: Laparoscopic uterine nerve ablation: a survey of gynaecological practice in the UK

q 2000 Blackwell Science Ltd Gynaecological Endoscopy 2000 9, 157±159 157

Laparoscopic uterine nerve ablation: a survey ofgynaecological practice in the UK

Jane Daniels,1 Richard Gray,1 Khalid S. Khan2 and Janesh K. Gupta2

1 Clinical Trials Unit, University of Birmingham, UK2 Department of Obstetrics and Gynaecology, University of Birmingham, UK

ABSTRACT

Objective To determine the current use of and the indications for laparo-scopic uterine nerve ablation (LUNA) in the UK, and to establish practi-tioners' views regarding the desirability of a controlled clinical trial to assessthe efficacy of LUNA.Setting Gynaecologists associated with the British Society of GynecologicalEndoscopy.Design A self-administered structured questionnaire was posted to 457 UKgynaecologists. Their surgical practice and willingness to participate in arandomized trial were surveyed. The postal questionnaire was returnedby 249 (55% response rate).Results The survey indicated that 113 (45%) of the responders per-formed LUNA. Of these, 86 (76%) carried out LUNA for chronic pelvicpain, 72 (64%) for endometriosis, and 16 (14%) for dyspaurenia/dysme-norrhoea. Diathermy was used as the surgical tool by 66 (59%) gynae-cologists and laser was used by 57 (51%). Of the 113 currently using LUNA,91 (81%) were willing to enter patients into a proposed clinical trialof LUNA.Conclusion Current clinical practice regarding LUNA for pelvic pain ishung in equipoise. This means that the technique has been introducedwithout reliable evidence of efficacy but opinion regarding its use is notyet solidified. Hence, a rigorous randomized trial of LUNA's efficacy isurgently needed and is practicable.

Keywords

laparoscopic uterine nerve ablation(LUNA), questionnaire.

Correspondence

K. S. Khan, Academic Department ofObstetrics and Gynaecology, BirminghamWomen's Healthcare NHS Trust,Birmingham B15 2TG, UK.

Accepted for publication 29 July 1999

INTRODUCTION

Chronic pelvic pain, de®ned as constant or intermit-tent, cyclic or acyclic pelvic pain that persists for 6months or more,1 has a major impact on health-relatedquality of life, work productivity and health care utili-zation, costing an estimated 158 million pounds peryear in the UK.2 Dysmenorrhoea, deep dyspareuniaand intermenstrual pain constitute the main symptomcomplex in chronic pelvic pain, which frequently leadsto surgical interventions including laparoscopy.3,4

With recent developments in minimal access surgery,laparoscopic uterosacral nerve ablation (LUNA) is apracticable treatment option at the time of diagnostic

laparoscopy in chronic pelvic pain.4 By interruptingpain pathways in the nerve plexuses and ganglia ofthe uterosacral ligaments LUNA is expected to alleviatepelvic pain.5,6

However, the therapeutic role of this interventionhas not been adequately assessed by rigorous clinicalresearch.7 Despite the lack of de®nitive evidence, manygynaecologists familiar with the operative techniqueoffer LUNA as a therapeutic option to their patientswith pelvic pain. This discrepancy between evidenceand practice induced us to examine current surgicalpractices regarding LUNA and to determine practi-tioners' willingness to participate in a clinical trial ofLUNA.

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158 J. DANIELS e t al .

METHODS AND RESULTS

We undertook a self-administered postal survey ofgynaecologists associated with the British Society ofGynaecological Endoscopy. In view of declining returnrates to mailed questionnaires, we designed our surveystrategy to include the factors known to be associatedwith higher response.8,9 Questionnaires were postedto 457 gynaecologists. Of these, 249 returned thequestionnaires, which gave a 55% response rate. Res-ponses to individual items were missing from somerespondents.

Table 1 shows the results of the survey. There were113 (45%) gynaecologists who carried out LUNA. Ofthese, 86 (76%) performed LUNA for chronic pelvicpain, 72 (64%) for endometriosis, and 16 (14%) fordyspaurenia/dysmenorrhoea. Diathermy was used asthe surgical tool by 66 (59%) gynaecologists and laserwas used by 57 (51%). More importantly, of the 113currently using LUNA, 91 (81%) gynaecologists werewilling to enter patients into a proposed clinical trialof LUNA.

DISCUSSION

The generalizability of our ®ndings may be somewhatdiminished by the relatively low rate of response toour questionnaire. Although we made all efforts withinour means to enhance the return rate,8,9 we receivedreplies from just 55% of gynaecologists, a rate lowerthan that reported in other recent surveys.10±12 Thereare several reasons for non-response, including out-of-date addresses, but the main reason might havebeen that LUNA has been promoted as an effectivetreatment in endometriosis based on one in¯uentialtrial.13 This trial was rigorous, but because of its designit was not possible to distinguish whether the treatmenteffect was caused by the transection of the uterosacralligaments or by the ablation of the endometrioticlesions. Indeed, subsequent research has shown thatLUNA may not have been the main factor alleviatingpain in endometriosis.14 Lack of this informationmight have led some gynaecologists to believe thatfurther research on LUNA lacks relevance, leadingto an unenthusiastic attitude towards our question-naire. However, there has been a trend towards reduc-tion in response to questionnaire surveys8 and so our55% response rate should be considered reasonableand does not invalidate our ®ndings.

The assessment of new surgical interventionsrequires an initial assessment of safety and practicability

followed by a proper randomized evaluation.15 Weundertook a systematic literature review concerningLUNA,7 which identi®ed only a few publications withevaluative evidence on LUNA. Moreover, this litera-ture consisted largely of observational uncontrolledcase series and poor quality controlled studies whichcould not be regarded as anything more than sugges-tive evidence. The initial evaluative evidence aloneis not suf®cient to assess the clinical effectiveness ofLUNA for which a larger, properly randomized trial,unconfounded by other variables, is needed. Thisneed has been highlighted in several recent publica-tions.16±18 From our survey, it is disturbing to notethat many gynaecologists are performing LUNA asa routine therapeutic procedure when evidence isinsuf®cient to establish ef®cacy. On the other hand

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Table 1 Current UK gynaecological practice concerninglaparoscopic uterosacral nerve ablation (LUNA), according togynaecologist's willingness to participate in a proposed trial ofLUNA

Willing to Unlikely toparticipate participaten (%) n (%)

Indications for LUNA

Chronic pelvic painOnly 25 (28) 3 (14)�Endometriosis 36 (40) 8 (36)�Other 7 (8) 1 (4)�Endometriosis�other 4 (4) 2 (9)

EndometriosisOnly 12 (13) 3 (14)�Other 4 (4) 3 (14)

OtherOnly 1 (1) 1 (4)

Not recorded 2 (2) 1 (4)

Total 91 22

Surgical technique for LUNA

DiathermyOnly 37 (41) 1 (4)�Laser 10 (11) 6 (27)� Scissors 8 (9) 2 (9)�Laser� scissors 1 (1) 1 (4)

LaserOnly 28 (31) 10 (45)� Scissors 1 (1) 0 (0)

ScissorsOnly 3 (3) 0 (0)

Not recorded 3 (3) 2 (9)

Total 91 22

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SURVEY OF LAPAROSCOPIC UTERINE ABLATION 159

it is encouraging that many gynaecologists wish toparticipate in a clinical trial. This is a situation whereequipoise applies (i.e. the technique has been intro-duced without de®nite evidence but opinion regard-ing its use is not yet solidi®ed) making the need fora trial even more urgent.

Encouraged by our survey, we have launched a multi-centre, prospective, blind, randomized controlledtrial assessing LUNA. Eligible consenting patients arerandomly allocated at diagnostic laparoscopy eitherto LUNA or to no pelvic denervation.19 The mainendpoints for assessing the ef®cacy of LUNA are pain,sexual function and quality of life. Long-term followup will be undertaken as well as short-term monitoring.This study is being coordinated from the Universityof Birmingham Clinical Trials Unit, and interestedgynaecologists are welcome to participate. We awaitwith interest the results of this trial.

REFERENCES

1 Vercellini P, Fedele L, Arcani L, Bianchi S, Rognoni MT,Candiani GB. Laparoscopy in the diagnosis of chronicpelvic pain in adolescent women. Journal of ReproductiveMedicine 1989; 34: 827±30.

2 Davies L, Ganger KF, Drummond M, Saunders D,Beard RW. The economic burden of intractablegynaecological pain. Journal of Obstetrics and Gynaecology1992; 12: s46±s54.

3 Howard FM. The role of laparoscopy in chronic pelvicpain: promise and pitfalls. Obstetrical and GynecologicalSurvey 1993; 48: 357±87.

4 Dwarakanath LS, Parsad PS, Khan KS. Role oflaparoscopy in the management of chronic pelvic pain.Hospital Medicine 1998; 59 (8): 627±31.

5 Frankenhauser G. Die Bewegungenerven derGebarmutter. Zeitschrift fuÈr Medizin Nat Wiss 1864; 1: 35.

6 Doyle JB, Des Rosiers JJ. Paracervical uterine denervationfor the relief of pelvic pain. Clinical Obstetrics andGynecology 1963; 6: 742±53.

7 Khan KS, Khan SF, Nowsu CR, Dwarakanath LS,Chein PFW. Laparoscopic uterine nerve ablation inchronic pelvic pain: an overview. Gynaecological Endoscopy,1998; 8: 257±67.

8 McAvoy BR, Kaner EF. General practice postal surveys: aquestionnaire too far? BMJ British Medical Journal 1996;313: 732±3.

9 Heywood A, Mudge P, Ring I, Sanson-Fisher R. Reducingsystematic bias in studies of general practitioners: the useof a medical peer in the recruitment of generalpractioners in research. Family Practice 1995; 12: 227±31.

10 McColl A, Smith H, White P, Field J. Generalpractitioners' perceptions of the route to evidence basedmedicine: a questionnaire survey. BMJ British MedicalJournal 1998; 316: 361±5.

11 Olatunbosun OA, Edouard L, Pierson RA. Physicians'attitudes toward evidence based obstetrics practice: aquestionnaire survey. BMJ British Medical Journal 1998;316: 765±6.

12 Gulmezoglu AM, Duley L. Use of anticonvulsants ineclampsia and pre-eclampsia: survey of obstetricians inthe United Kingdom and Republic of Ireland. BMJBritish Medical Journal 1998; 316: 975±6.

13 Sutton CJG, Ewen SP, Whitelaw N, Haines B. Prospective,randomised, double blind controlled trial of laserlaparoscopy in the treatment of pelvic pain associatedwith minimal, mild, and moderate endometriosis.Fertility and Sterility 1994; 62: 696±700.

14 Dover RW, Pooley A, Haines P, Sutton CJG. Aprospective randomised double-blind trial oflaparoscopic laser uterine nerve ablation in thetreatment of pelvic pain associated with endometriosis:a proviaional report. British Journal of Obstetrics andGynaecology 1998; 105 (Suppl. 17): 48.

15 Cushcieri A. Minimal access therapy: scope,evaluation and future direction. Health Bulletin 1996;54: 514±21.

16 Stones RW. Chronic pelvic pain. Personal Assessment inContinuing Education. Review No 97/01. London: RoyalCollege of Obstetricians and Gynaecologists, 1997.

17 Stones RW, Mount®eld J, Farquhar C. Management ofchronic pelvic pain in women. In: Farquhar C, Cook I,Barlow D, eds. Menstrual Disorders Module of the CochraneDatabase of Systematic Reviews. Oxford: The CochraneCollaboration, update software 1998.

18 Porpora MG, Victor G. The role of laparoscopy in themanagement of pelvic pain in women of reproductiveage. Fertility and Sterility 1997; 68: 765±79.

19 Birmingham Clinical Trials Unit. The LUNA trial. URL.http://www.cancer.bham.ac.uk/research/luna/lunamain.htm (12 March 1999).

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