New research article published in BMJ Open, more FEMaLers involved: ‘Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial?‘
For women with peritoneal endometriosis, there is uncertainty regarding the pain-relieving effect of surgery. Surgery may put patients at risk of complications such as postsurgical neuropathic pain, without guarantees of sufficient pelvic pain relief. The planned placebo-controlled trial aims to examine the effect of surgery on pelvic pain, widespread pain and neuropathic pain symptoms in women with peritoneal endometriosis, and to test the contribution of contextual factors to pain relief.
Strengths and limitations of this study:
- This trial employs a placebo-controlled surgical design with three arms, including a no-surgery control group.
- This trial assesses contextual factors that are largely unexamined in placebo-surgical studies, but have been associated with pain relief in non-surgical trials.
- By allocating patients between active and sham surgery in the operating room, and having blinded personnel responsible for postsurgical care, the trial should effectively be double-blinded.
- Quantitative sensory testing and risk factors of chronic postsurgical pain and neuropathic pain are used to examine risks.
- Limitations include a relatively short follow-up period and minor uncertainty in terms of the diagnosis of peritoneal endometriosis in the placebo arm, as biopsy confirmation would impede the validity of the sham procedure.
Access the study here.