OBJECTIVE: To compare the effectiveness of sharp excision of endometriosis with sham surgical excision in alleviating endometriosis-associated pain for up to 1 year following surgery. METHODS:Patients requiring a laparoscopy for severe pelvic pain were eligible. If endometriosis was visually identified at laparoscopy, a biopsy of a representative lesion was taken. The women were then randomized either to have all remaining endometriosis excised with laparoscopic scissors (the excision group) or to have no further surgical treatment (the control group). Patients were asked to complete daily pain scales for 1 month preoperatively and quarterly for 1 year postoperatively. Subjects were blinded to their treatment allocation for 1 year. RESULTS:Twenty-nine women underwentlaparoscopy and biopsy and were randomized to have excision or no treatment of endometriosis. The excision and control groups were similar in age, parity, and revised American Society for Reproductive Medicine stage of disease. Sixteen women completed the full year of follow-up: 9 in the excision group, and 7 in the control group. Overall, recorded pain was significantly reduced at 1 year (P < 0.05), with no significant difference between the excision and control groups. CONCLUSION:Laparoscopy with diagnostic biopsy alone is associated with a significant reduction in pain for up to 1 year postoperatively. Although the study lacked sufficient statistical power to exclude an effect of excision, pain relief in each group was similar. These results indicate a potential benefit of sham surgical procedures in assessing novel surgical interventions.
RCT Entities:
OBJECTIVE: To compare the effectiveness of sharp excision of endometriosis with sham surgical excision in alleviating endometriosis-associated pain for up to 1 year following surgery. METHODS:Patients requiring a laparoscopy for severe pelvic pain were eligible. If endometriosis was visually identified at laparoscopy, a biopsy of a representative lesion was taken. The women were then randomized either to have all remaining endometriosis excised with laparoscopic scissors (the excision group) or to have no further surgical treatment (the control group). Patients were asked to complete daily pain scales for 1 month preoperatively and quarterly for 1 year postoperatively. Subjects were blinded to their treatment allocation for 1 year. RESULTS: Twenty-nine women underwent laparoscopy and biopsy and were randomized to have excision or no treatment of endometriosis. The excision and control groups were similar in age, parity, and revised American Society for Reproductive Medicine stage of disease. Sixteen women completed the full year of follow-up: 9 in the excision group, and 7 in the control group. Overall, recorded pain was significantly reduced at 1 year (P < 0.05), with no significant difference between the excision and control groups. CONCLUSION: Laparoscopy with diagnostic biopsy alone is associated with a significant reduction in pain for up to 1 year postoperatively. Although the study lacked sufficient statistical power to exclude an effect of excision, pain relief in each group was similar. These results indicate a potential benefit of sham surgical procedures in assessing novel surgical interventions.
Authors: David J Beard; Marion K Campbell; Jane M Blazeby; Andrew J Carr; Charles Weijer; Brian H Cuthbertson; Rachelle Buchbinder; Thomas Pinkney; Felicity L Bishop; Jonathan Pugh; Sian Cousins; Ian Harris; L Stefan Lohmander; Natalie Blencowe; Katie Gillies; Pascal Probst; Carol Brennan; Andrew Cook; Dair Farrar-Hockley; Julian Savulescu; Richard Huxtable; Amar Rangan; Irene Tracey; Peter Brocklehurst; Manuela L Ferreira; Jon Nicholl; Barnaby C Reeves; Freddie Hamdy; Samuel Cs Rowley; Naomi Lee; Jonathan A Cook Journal: Health Technol Assess Date: 2021-09 Impact factor: 4.014
Authors: Karolina Wartolowska; Andrew Judge; Sally Hopewell; Gary S Collins; Benjamin J F Dean; Ines Rombach; David Brindley; Julian Savulescu; David J Beard; Andrew J Carr Journal: BMJ Date: 2014-05-21
Authors: Wayne B Jonas; Cindy Crawford; Luana Colloca; Ted J Kaptchuk; Bruce Moseley; Franklin G Miller; Levente Kriston; Klaus Linde; Karin Meissner Journal: BMJ Open Date: 2015-12-11 Impact factor: 2.692