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To excise or ablate endometriosis? A prospective randomized double blinded trial with 5 years follow-up.

Prospective randomized double blinded controlled trial comparing treatment of endometriosis with excision versus ablation on pain, rates of pregnancy, repeat surgery and use of hormonal medication in the 5 years post-operation.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001049763
Enrollment
180
Registered
2013-09-20
Start date
2001-07-02
Completion date
2007-09-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objective: To compare reduction of pain following laparoscopy after ablation or excision of endometriosis. Design: A prospective, randomized, double-blind study. Setting: Endometriosis and pelvic pain clinic at a university teaching hospital. Patients: Women of reproductive age presenting with pelvic pain and visually proven endometriosis. Interventions: Subjects completed a questionnaire rating their various pains using visual analogue scales (VAS). Following visual identification subjects were randomised to treatment with ablation or excision by supervised training gynecologists as primary surgeon. Follow-up questionnaires documented pain levels every 3 months for 1 year then 6 monthly until 5 years. Main Outcome Measure: Change in pain VAS scores during 5 years post-operation and rates of pregnancy, repeat surgery and use of hormonal medication Results: There was a reduction in all pain scores over the five year follow up in both treatment groups. A significantly greater reduction in sex pain VAS scores was seen in the excision group at 3 years 6 months (p=0.015); 4 years 6 months (p=0.047) and at 5 years (p=0.031). More women went on to use medical treatments for endometriosis amongst the ablation group (p=0.004) by 5 years. Conclusions: Surgical treatment of endometriosis provides symptom reduction for up to 5 years. There are some limited areas, such as deep dyspareunia, where excision is more effective than ablation.

Interventions

Interventions - Excision of endometriosis. To excise the endometriosis, spade with monopolar current or scissors are used to cut out the endometriosis. Duration of the procedure depends on the amount of endometriosis present and expertise of the surgeon.

Sponsors

A/Prof Martin Healey
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Women booked to have a laparoscopy to manage pain symptoms suggestive of endometriosis, over 18 years, speak English, not be using or planning to use continuous hormonal medications and give consent to the trial.

Exclusion criteria

Under 18 years and over 50 years. Do not speak English. Do not consent. Use or planning to use continuous hormonal medications.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026