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Laparoscopic surgery for pelvic pain associated with endometriosis

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Referencias

References to studies included in this review

Abbott 2004 {published and unpublished data}

Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo‐controlled trial. Fertility and Sterility 2004;82(4):878‐84.

Jarrell 2005 {published data only (unpublished sought but not used)}

Jarrell J, Mohindra R, Ross S, Taenzer P, Brant R. Laparoscopy and Reported Pain Among Patients With Endometriosis. Journal of Obstetrics and Gynaecology Canada 2005;27(5):477‐83.

Lalchandani 2003 {published data only (unpublished sought but not used)}

Lalchandani S, Baxter A, Phillips K. Is helium thermal coagulator therapy for the treatment of women with minimal to moderate endometriosis cost effective? A prospective randomised controlled trial. Gynaecological Surgery 2005;2:225‐58.
Lalchandari S, Baxter A, Phillips K. A prospective, randomised comparison of laparoscopic treatment and treatment with gonadotrophin releasing hormone analogue in patients with mild to moderate endometriosis. International Journal of Obstetrics and Gynaecology. 2003; Vol. 83 (S3):48.

Sutton 1994 {published data only}

Sutton CJG, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double‐blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild and moderate endometriosis. Fertility & Sterility 1994;62:696‐700.
Whitelaw NL, Haines P, Ewen SP, Sutton CJG. Assessing the efficacy of laser laparoscopy in the treatment of endometriosis. Journal of Obstetrics & Gynaecology 1993;13(6):486.

Tutunaru 2006 {published data only (unpublished sought but not used)}

Tutunaru D, Vladareanu R, Dumitrascu MC, Alexandru B. Placebo effect of diagnostic laparoscopy alone in mild endometriosis. Gynaecology and Obstetrics. 2006; Vol. 2:144.

References to studies excluded from this review

Beretta 1998 {published data only}

Beretta P, Franchi M, Ghezzi F, Busacca M, Zupi E, Bolis P. Randomized clinical trial of two laparoscopic treatments of endometriomas: cystectomy versus drainage and coagulation. Fertility & Sterility 1998;70(6):1176‐80.

Candiani 1992 {published data only}

Candiani GB, Fedele L, Vercellini P, Bianchi S, Di Nola G. Presacral neurectomy for the treatment of pelvic pain associated with endometriosis: a controlled study. American Journal of Obstetrics & Gynecology 1992;167:100‐3.

Dover 1999 {unpublished data only}

Dover RW, Pooley A, Haines P, Sutton CJG. Prospective, randomised, double blind controlled trial of laparoscopic uterine nerve ablation in the treatment of pelvic pain associated with endometriosis. (Unpublished).

Mais 1996 {published data only}

Mais V, Ajossa A, Guerriero S, Piras B, Floris M, Palomba M, Melis GB. Laparoscopic management of endometriomas: a randomized trial versus laparotomy. Journal of Gynecologic Surgery 1996;12:41‐6.

Sutton 1993 {published data only}

Sutton CJG, Nair S, Ewen SP, Haines P. A comparison between the CO2 and KTP lasers in the treatment of large ovarian endometriomas. Gynaecological Endoscopy 1993;2:113.

Sutton 1997 {published data only}

Sutton CJG, Ewen SP, Whitelaw N, Haines P, Pooley A. Prospective, randomised, double blind, controlled trial of laser laparoscopy against placebo in stages I‐III endometriosis: one year follow‐up data.. 27th British Congress of Obstetrics and Gynaecology. 1995:176 (Abstract).
Sutton CJG, Jones KD, Haines P. A long term follow up report on patients who underwent laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.. British Society for Gynaecological Endoscopy Annual Scientific Meeting.. Plymouth, 1999.
Sutton CJG, Pooley AS, Ewen SP, Haines P. Follow‐up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis. Fertility & Sterility 1997;68:1070‐4.

Vercellini 1997 {published data only}

Vercellini P, Aimi G, Busacca M, Uglietti A, Vignali M, Crosignani PG. Laparoscopic uterosacral ligament resection for dysmenorrhoea associated with endometriosis: results of a randomized controlled trial. Fertility & Sterility 1997;Oct(Suppl):S3 (abstract).

Wright 2005 {published data only}

Wright J, Lotfallah H, Jones K, Lovell D. A randomized trial of excision versus ablation for mild endometriosis. Fertility and Sterility 2005;83(6):1830‐36.

Additional references

Adamson 1990

Adamson GS. Diagnosis and clinical presentation of endometriosis. American Journal of Obstetrics & Gynecology 1990;162:568‐9.

Am Fert Soc 1985

American Fertility Society. Revised American Fertility Society classification of endometriosis. Fertility & Sterility 1985;43:351‐2.

Barbieri 1982

Barbieri RL, Evans S, Kistner RW. Danazol in the treatment of endometriosis: analysis of 100 cases with four year follow‐up. Fertility & Sterility 1982;37:737‐45.

Batioglu 1996

Batioglu S, Celikkanat H, Ugur M, Mollamahmutoglu L, Yesilyurt H, Kundakci M. The use of GnRH agonists in the treatment of endometriomas with or without drainage. Journal of Pakistan Medical Association 1996;46:30‐2.

Chen 1997

Chen FP, Soong YK. The efficacy and complications of laparoscopic presacral neurectomy in pelvic pain. Obstetrics & Gynecology 1997;90:974‐7.

Crosignani 1996

Crosignani PG, Vercellini P, Biffignandi F, Costantini W, Cortesi I, Imparato E. Laparoscopy versus laparotomy in conservative surgical treatment for severe endometriosis. Fertility & Sterility 1996;66(5):706‐11.

Federici 1996

Federici D, Brambilla T, Lacelli B, Arcaini L, Motta G, Agarossi A, et al. Pain relief after combined medical and laparoscopic conservative treatment of stage III‐IV endometriosis: a comparison with medical therapy. Minimally Invasive Therapy & Allied Technologies: Mitat 1996;5:547‐54.

Garry 2000

Garry R, Clayton R, Hawe J. The effect of endometriosis and its radical laparoscopic excision on quality of life indicators. BJOG: British Journal of Obstetrics & Gynaecology 2000;107(1):44‐54.

Hefni 1997

Hefni M. Comparison controlled study of GnRH analogue (goserelin) and laparoscopic diathermy for the treatment of endometriosis. Acta Obstetricia et Gynecologica Scandinavica 1997;76(Suppl):77.

Higgins 2008

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane‐handbook.org.

Li 2005

Li P, Mah D, Lim K, Sprague S, Bhandari M. Randomization and concealment in surgical trials: a comparison between orthopaedic and non‐orthopaedic randomized trials. Archives of Orthopeadic and Trauma Surgery 2005;125(1):1434‐3916.

Mahmood 1990

Mahmood TA, Templeton A. The impact of treatment on the natural history of endometriosis. Human Reproduction 1990;5(8):965‐70.

Moen 1991

Moen MH, Muus KM. Endometriosis in pregnant and non‐pregnant women at tubal sterilisation. Human Reproduction 1991;6:699‐702.

Overton 1994

Overton CE, Siddle NC, Barlow DH, Johal B, Collins SA, Siddle NC, Shaw RW, Barlow DH. A randomised, double blind, placebo‐controlled study of luteal phase dydrogesterone (Duphaston) in women with minimal to mild endometriosis. Fertility & Sterility 1994;62:701‐7.

Parazzini 1994a

Parazzini F, Luchini L, Vezzoli F, Mezzanotte C, Vercellini P, Romanini C et. al. Prevalence and anatomical distribution of endometriosis in women with selected gynaecological conditions: results from a multicentric Italian study. Human Reproduction 1994;6:1158‐62.

Parazzini 1994b

Parazzini F, Ferraroni M, Bocciolone L, Tozzi L, Rubessa S, La Vecchia C. Contraceptive methods and risk of pelvic endometriosis. Contraception 1994;49:47‐55.

Prentice 1999

Prentice A, Deary AJ, Goldbeck‐Wood S, Farquhar C, Smith SK. Gonadotrophin Releasing Hormone Analogues (GnRHas) for painful symptoms associated with endometriosis (Cochrane Review). Cochrane Database of Systematic Reviews 1999, Issue 1. [DOI: 10.1002/14651858.CD001300]

Querleu 1993

Querleu D, Chevallier L, Chapron C, Bruhat M. Complications of gynaecological endoscopic surgery. A French multicenter collaborative study. Gynaecological Endoscopy 1993;2:3‐6.

Redwine 1991

Redwine DB. Conservative laparoscopic excision of endometriosis by sharp dissection: life table analysis of reoperation and persistent or recurrent disease. Fertility & Sterility 1991;56(4):628‐34.

Sampson 1927

Sampson JA. Peritoneal Endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. American Journal of Obstetrics & Gynecology 1927;14:422‐69.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Dimesions of Methodological Quality Associated with Estimates of Treatment Effects in Controlled Trials. The Journal of the American Medical Association 1995;273(5):408‐412.

Sutton 1994

Sutton CJG, Ewen SP, Whitlaw N, Haines P. Prospective, randomized, double blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild and moderate endometriosis. Fertility & Sterility 1994;62:696‐700.

Venturini 1990

Verturini PL, Fasce V, Constantini S, Anserini P, Cucuccio S, De Cecco L. Treatment of endometriosis with goserelin depot, a long‐acting gonadotrophin releasing hormone agonist analogue: endocrine and clinical results. Fertility & Sterility 1990;54:1021‐7.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abbott 2004

Methods

Randomisation by computer generated randomisation sequence.

Allocation concealment not referred to within the text.

Double blinded. Participant and observer.
39 women entered the study. 37 completed to 6 month follow up.

Participants

Location: Middlesbrough, UK.
Inclusion criteria: Clinical symptoms and signs suggestive of endometriosis, such as dysmenorrhoea, and pelvic abnormality on examination, in association with histologic evidence of endometriosis at the time of surgery.
Exclusion criteria: women were excluded if they had suspected gynaecologic malignancy or its precursors, current or chronic pelvic inflammatory disease, or became pregnant preoperatively.

Interventions

Laparoscopic excision of areas of endometriosis.
Control: Diagnostic laparoscopy only.

Outcomes

Pain symptoms were recorded by being asked to complete a visual analogue score before the intervention and again six months after the procedure. Participants were asked to complete a visual analogue score.

Post‐operative complications were reported.

Notes

Ethics committee approval was obtained.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated randomisation sequence.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not referred to within the text.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Double blinded. Participant and observer.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Jarrell 2005

Methods

Randomisation by computer generated randomisation sequence.

Allocations contained within opaque envelopes.

Double blinded. Participant and observer.
29 women entered the study. 28 completed to 12 month follow up.

Participants

Location: Calgary, Canada.
Inclusion criteria: Severe pelvic pain requiring investigation, premenopausal state and no evidence of pregnancy.
Exclusion criteria: women were excluded if there was severe ancillary medical disease, endometriosis that was too extensive to resect at laparoscopy and symptoms requiring urgent intervention.

Interventions

Laparoscopic excision of areas of endometriosis.
Control: Diagnostic laparoscopy only.

Outcomes

Pain symptoms were recorded by being asked to complete daily visual analogue scales for one month at three month intervals post‐operatively for twelve months. The mean pain scores were reported by the study six and twelve months post operatively, however we have assumed the error bars of figure 5 represent standard deviation and not the standard error of the mean.

Notes

Ethics committee approval was obtained.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated randomisation sequence.

Allocation concealment (selection bias)

Low risk

Allocations contained within opaque envelopes.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Double blinded. Participant and observer.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Lalchandani 2003

Methods

Randomisation method was unclear.

Allocation concealment not referred to within the text.

Presence of blinded was unclear.
35 women entered the study. 35 completed to 12 month follow up.

Participants

Location: Limerick, Republic of Ireland.
Inclusion criteria: Women presenting to the gynaecology outpatient clinic with a history of pelvic pain, dysmenorrhoea, dyspareunia and dyschezia suggestive of endometriosis or who had previously been diagnosed as having the disease.
Exclusion criteria: Women who were less than 16 years old, pregnant or subfertile were excluded.

Interventions

Laparoscopic coagulation therapy of areas of endometriosis.
Control: Diagnostic laparoscopy only plus medical treatment with GnRHa (injectable goserelin and tibolone add back).

Outcomes

Pain symptoms were recorded by being asked to complete a visual analogue score before the intervention and again three, six and twelve months after the procedure.

Reported the mean operative time.

Notes

Ethics committee approval was obtained.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Stated as randomised.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not referred to within the text.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Not referred to within the text.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Sutton 1994

Methods

Randomisation by computer generated randomisation sequence.

Double blinded. Participant and observer.

Allocation concealment not referred to within the text.Not referred to within the text.
74 women entered the study. 63 completed to 6 month follow up

Participants

Location Guildford UK,
Inclusion criteria: Age 18‐45. Women recruited from gynaecological outpatient clinic with pain suggestive of endometriosis and advised to undergo laparoscopy. Not pregnant or lactating and no treatment for endometriosis within last 6 months
Exclusion criteria: women in severe pain due to stage IV endometriosis

Interventions

Laser treatment including vaporisation of all visible endometriotic implants, adhesiolysis, and uterine nerve transection.
Control: Diagnostic laparoscopy only with aspiration of peritoneal fluid

Outcomes

Reported pain scores and 10cm linear analogue visual scale for dysmenorrhoea, dyspareunia, and pelvic pain, before the procedure and three and six months after the procedure.

Post‐operative complications were reported.

Notes

Ethics committee approval was obtained.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated randomisation sequence.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not referred to within the text.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Double blinded. Participant and observer.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

74 women entered the study. 63 completed to 6 month follow up. No reasons were stated for 4 participants.

Selective reporting (reporting bias)

Unclear risk

It is unclear how many women underwent one, two or all of the three potential interventions of laser ablation, adhesiolysis and uterine nerve ablation.

Tutunaru 2006

Methods

Randomisation method unclear.

Allocation concealment not referred to within the text.

Stated as single‐blinded, patient or research nurse blinded unclear.
69 women entered the study. 69 completed to 12 month follow up.

Participants

Location: Bucharest, Romania.
Inclusion criteria: women in reproductive age, with endometriotic implants discovered by laparoscopy done because of dysmenorrhoea who have signed consent forms.
Exclusion criteria: Severe adhesions, prior abdominal surgery, unwilling to comply with the study.

Interventions

Laparoscopic excision or coagulation of areas of endometriosis.
Control: Diagnostic laparoscopy only.

Outcomes

Pain symptoms were recorded by being asked to complete a visual analogue score before the intervention and again six and twelve months after the procedure.

Notes

Infomed consent was obtained.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Stated as randomised.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not referred to within the text.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Not referred to within the text.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

It is unclear how many women underwent one or two of the two potential interventions of laser ablation and coagulation.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Beretta 1998

Comparison of two laparoscopic methods of treatment rather than comparison to non‐laparoscopic methods

Candiani 1992

Comparison between two laparoscopic methods rather than laparoscopic methods with other treatment modalities

Dover 1999

Unpublished data. Comparison of laparoscopic laser ablation to laparoscopic laser ablation plus LUNA. No comparison to non‐laparoscopic treatment

Mais 1996

Randomised controlled study. Comparison of laparoscopy versus laparotomy for treatment of endometriomas. Outcome measures related to operating time and speed of recovery rather than improvement in symptoms.

Sutton 1993

Abstract only. No data reported. Comparison of two laparoscopic techniques.

Sutton 1997

Data not suitable for analysis of follow up as in most cases randomisation code was broken at six months and further surgery offered to expectant group.

Vercellini 1997

Comparison of two different laparoscopic methods rather than laparoscopic surgery with another treatment modality.

Wright 2005

Comparison of two different laparoscopic methods rather than laparoscopic surgery with another treatment modality.

Data and analyses

Open in table viewer
Comparison 1. Laparoscopic surgery versus no surgery

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain better or improved Show forest plot

3

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 1 Pain better or improved.

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 1 Pain better or improved.

1.1 After 3 months

1

63

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.36 [0.51, 3.64]

1.2 After 6 months

3

171

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.72 [3.09, 10.60]

1.3 After 12 months

1

69

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.72 [2.97, 20.06]

2 Pain scores Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 2 Pain scores.

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 2 Pain scores.

2.1 6 months

1

16

Mean Difference (IV, Fixed, 95% CI)

0.90 [0.31, 1.49]

2.2 12 months

1

16

Mean Difference (IV, Fixed, 95% CI)

1.65 [1.11, 2.19]

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Forest plot of comparison: 1 Laparoscopic surgery versus no surgery, outcome: 1.1 Pain better or improved.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Laparoscopic surgery versus no surgery, outcome: 1.1 Pain better or improved.

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 1 Pain better or improved.
Figuras y tablas -
Analysis 1.1

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 1 Pain better or improved.

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 2 Pain scores.
Figuras y tablas -
Analysis 1.2

Comparison 1 Laparoscopic surgery versus no surgery, Outcome 2 Pain scores.

Comparison 1. Laparoscopic surgery versus no surgery

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain better or improved Show forest plot

3

Peto Odds Ratio (Peto, Fixed, 95% CI)

Subtotals only

1.1 After 3 months

1

63

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.36 [0.51, 3.64]

1.2 After 6 months

3

171

Peto Odds Ratio (Peto, Fixed, 95% CI)

5.72 [3.09, 10.60]

1.3 After 12 months

1

69

Peto Odds Ratio (Peto, Fixed, 95% CI)

7.72 [2.97, 20.06]

2 Pain scores Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 6 months

1

16

Mean Difference (IV, Fixed, 95% CI)

0.90 [0.31, 1.49]

2.2 12 months

1

16

Mean Difference (IV, Fixed, 95% CI)

1.65 [1.11, 2.19]

Figuras y tablas -
Comparison 1. Laparoscopic surgery versus no surgery