Laparoscopic excision of endometriosis: A randomized, placebo-controlled trial

Abbott, Jason; Hawe, Jed; Hunter, David; Holmes, Michael; Finn, Paul; Garry, Ray

doi:10.1016/j.fertnstert.2004.03.046

Cited by 443 publications

(368 citation statements)

References 23 publications

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“…What is interesting is that the greatest reduction in pain scores after treatment was observed in the highest stages of endometriosis (stages II and III of the American Society for Reproductive Medicine (ASRM) classification), while stage I showed moderate improvement in pain scores [5]. Nevertheless, in a randomized, placebo-controlled trial, laparoscopic excision of endometriosis resulted in significantly more symptomatic relief than laparoscopy alone (80% vs 32%) [6].…”

Section: Therapeutic Options For Pelvic Painmentioning

confidence: 99%

“…The pathophysiology of endometriosis, its effects on local surrounding organs and tissues, and the mechanisms by which it causes pain have been studied extensively [2]. As demonstrated by Sutton in 1994 and confirmed by Abbott 10 years later [5,6], both laparoscopic excision of endometriosis and laparoscopic ablation have produced significant reduction in pelvic pain. What is interesting is that the greatest reduction in pain scores after treatment was observed in the highest stages of endometriosis (stages II and III of the American Society for Reproductive Medicine (ASRM) classification), while stage I showed moderate improvement in pain scores [5].…”

Section: Therapeutic Options For Pelvic Painmentioning

confidence: 99%

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Surgical Options for the Treatment of Chronic Pelvic Pain

Morozov¹,

Dun²,

Katz³

et al. 2015

J Neurol Exp Neurosci

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Section: Therapeutic Options For Pelvic Painmentioning

confidence: 99%

Section: Therapeutic Options For Pelvic Painmentioning

confidence: 99%

Surgical Options for the Treatment of Chronic Pelvic Pain

Morozov¹,

Dun²,

Katz³

et al. 2015

J Neurol Exp Neurosci

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“…For example, the placebo procedure involved laparoscopy but without ablation 36 , endoscopy without radiofrequency energy delivery 37 , bronchoscopy without radiofrequency energy delivery 38 , or bronchoscopy without valve placement 39 . Therefore, most of the studies required a small incision to mimic the portals created during the laparoscopy or arthroscopy, or to mimic the incision through which an intravascular catheter was inserted 40 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…On the other hand, the procedure used for blinding may have diagnostic use, as with diagnostic laparoscopy 36, 41, 58 or diagnostic laparoscopy with biopsy 59 . In the trial by Sihvonen and colleagues, all participants underwent diagnostic arthroscopy, but only after they had been confirmed to be eligible for inclusion in the trial was the envelope with the assignment opened and the assignment revealed to the surgeon 48 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

“…Most trials blinded the assessors while the surgeon and other staff in the operating room were aware of the group assignment, and did not participate in further treatment, post-operative care or follow-up of the patient 36, 48, 67 . In a trial by Thomsen and colleagues, the post-operative care and assessment was done at a different hospital than the surgery 21 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

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Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms

Maheux-Lacroix

Deans

et al. 2021

JAMA

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IMPORTANCE Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.OBJECTIVE To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. DESIGN, SETTING, AND PARTICIPANTSA double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.INTERVENTIONS Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. MAIN OUTCOMES AND MEASURESThe co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). RESULTSOf 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.CONCLUSIONS AND RELEVANCE Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.

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Laparoscopic excision of endometriosis: A randomized, placebo-controlled trial

Cited by 443 publications

References 23 publications

Surgical Options for the Treatment of Chronic Pelvic Pain

Surgical Options for the Treatment of Chronic Pelvic Pain

Blinding in trials of interventional procedures is possible and worthwhile

Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms

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