None listed
Conditions
Brief summary
Aim: To assess the role of laparoscopic excision of endometriosis in women who have confirmed disease, and assess pain and quality of life (QoL) outcomes at 6 and 12 months following surgery. Methods: A double blind randomised, placebo-controlled, cross-over study. Women were randomised to an immediate or a delayed group. In the immediate group, women received laparoscopic excision of endometriosis at the time of first surgery and then a second look laparoscopy, with or without excision of additional disease 6 months later. In the delayed surgery group, women received a staging laparoscopy without excision at the time of first surgery, followed by laparoscopic excision of endometriosis 6 months later. Pain was assessed by dichotomous and continuous variables and QoL was assessed using the EuroQOL, SF-12 and sexual activity questionnaires. Patients: 52 women with suspected endometriosis were randomised in the study. Results: Three women withdrew before surgery owing to pregnancy; three without reason and seven were excluded following surgery when endometriosis was not confirmed. The remaining 39 women were operated on and the results analyses by intention to treat. At 6 months following surgery 1, 6/19 women (32%) in the delayed surgery group reported an improvement in symptoms, and 13/19 (68%) reported no improvement in symptoms. In the immediate surgery group, 16/20 (80%) reported an improvement in symptoms, and 4/20 (20%) reported no improvement in symptoms. There was a significant difference between the two groups (p=0.002). There was a significant improvement in many aspects of quality of life for women in the immediate surgery group compared to baseline, but no significant improvement for women in the delayed surgery group. Three women in the immediate surgery group became pregnant following their first surgery and did not have surgery 2. At 6 months following surgery 2, 15/18 women (83%) in the delayed surgery group reported an improvement in symptoms, and 3/18 (17%) reported no improvement in symptoms. The other woman in this group required treatment at surgery 1 due to severe disease. In the immediate surgery group, 8/15 (53%) of women reported a change in symptoms at 6 months following surgery 2, and 7/15 women (47%) reported no improvement in symptoms. There were 3 women pregnant in this group, one withdrawal following surgery, but before final follow-up and one women who had a complication at surgery 1 and did not have second surgery. There were significant improvements in all aspects of quality of life in both groups at the end of the study compared to baseline. Conclusion: Laparoscopic excision of endometriosis for women appears to be effective in reducing pain symptoms and improving quality of life compared to placebo. Surgery is associated with a 30% placebo response rate that is not dependent on severity of disease. Approximately 20% of women do not report an improvement following surgery for endometriosis. There is a significant improvement in many aspects of quality of life following surgery for endometriosis compared to placebo.
Interventions
Laparoscopic surgery which involves puncture of the abdomen at 4 sites, inflation of the abdomen with carbon dioxode, a review of the structures and disease and excision of the disease in the surgical arm. In the placebo surgery arm control group, scoring of disease and infusion saline fluid is used post-surgery in the placebo surgery arm. The surgery is then repeated again 6 months after the 1st surgery (crossover) with scoring and excision of disease in both groups. Therefore there is a 6 m
Laparoscopic surgery which involves puncture of the abdomen at 4 sites, inflation of the abdomen with carbon dioxode, a review of the structures and disease and excision of the disease in the surgical arm. In the placebo surgery arm control group, scoring of disease and infusion saline fluid is used post-surgery in the placebo surgery arm. The surgery is then repeated again 6 months after the 1st surgery (crossover) with scoring and excision of disease in both groups. Therefore there is a 6 month washout period. Patients are then followed up for 1 year with interview and questionnaire.
Sponsors
Dr Jason Abbott
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Pelvic pain (of greater than six months duration) with suspected endometriosis Examination findings suggestive of endometriosis A Ultrasound findings suggestive of an endometrioma. B Rectal ultrasound findings suggestive of infiltrative endometriosis such as uterosacral or rectal wall involvement. C Previous diagnostic or operative laparoscopy with visual suggestion of, or biopsy proven, disease.
Exclusion criteria
1. Suspected diagnosis of gynaecological malignancy or its precursors. 2. Current or chronic relapsing pelvic inflammatory disease. 3. Current pregnancy. 4. Infertility and endometriosis without pelvic pain. 5. Unable to give informed consent. 6. Unable or unwilling to attend for both surgeries and for follow-up to twelve months. 7. No histological confirmation of endometriosis.
Outcome results
None listed