Marijke J Molegraaf1, Bart Torensma2, Christopher P Lange3, Johan F Lange4, Johan Jeekel5, Dingeman J Swank3. 1. Department of General Surgery, Groene Hart Hospital, Gouda, The Netherlands; Department of General Surgery, Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: mjmolegraaf@gmail.com. 2. Department of Epidemiology, Leiden University Medical Center, Leiden, The Netherlands. 3. Department of General Surgery, Groene Hart Hospital, Gouda, The Netherlands. 4. Department of General Surgery, Erasmus Medical Center, Rotterdam, The Netherlands. 5. Department of Neuroscience, Erasmus Medical Center, Rotterdam, The Netherlands.
Abstract
BACKGROUND:Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial, and long-term effects are not known; therefore, our aim was to evaluate long-term effects of laparoscopic adhesiolysis for the treatment of chronic abdominal pain believed to be related to intraperitoneal adhesions. METHODS: A total of 100 patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 12-year follow-up. RESULTS: A total of 73% of patients fulfilled the long-term follow-up. Compared to the placebo group (n = 31), patients in the adhesiolysis group (n = 42) were significantly less often pain-free (8 vs 13, P = .033, relative risk [RR] = 1.3) and to have a greater intake of analgesics (26 vs 16, P = .379, RR = 1.2, 95% confidence interval 0.8-1.8). Moreover, the adhesiolysis group sought medical consultations more frequently (14 vs 6, P = .186, RR = 1.33, 95% confidence interval 0.9-1.9), and had an increased rate of additional operation (8 vs 1, P = .042, RR = 1.67, 95% confidence interval 1.208-2.318). Both groups had improved pain and quality-of-life scores. CONCLUSION: This is the first, long-term, placebo-controlled trial regarding the use of laparoscopic adhesiolysis for treating chronic abdominal pain. Laparoscopic adhesiolysis was less beneficial than laparoscopy alone in the long term. Secondly, there appeared to be a powerful, long-lasting placebo effect of laparoscopy. Because adhesiolysis is associated with an increased risk of operative complications, avoiding this treatment may result in less morbidity and health care costs.
RCT Entities:
BACKGROUND: Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial, and long-term effects are not known; therefore, our aim was to evaluate long-term effects of laparoscopic adhesiolysis for the treatment of chronic abdominal pain believed to be related to intraperitoneal adhesions. METHODS: A total of 100 patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 12-year follow-up. RESULTS: A total of 73% of patients fulfilled the long-term follow-up. Compared to the placebo group (n = 31), patients in the adhesiolysis group (n = 42) were significantly less often pain-free (8 vs 13, P = .033, relative risk [RR] = 1.3) and to have a greater intake of analgesics (26 vs 16, P = .379, RR = 1.2, 95% confidence interval 0.8-1.8). Moreover, the adhesiolysis group sought medical consultations more frequently (14 vs 6, P = .186, RR = 1.33, 95% confidence interval 0.9-1.9), and had an increased rate of additional operation (8 vs 1, P = .042, RR = 1.67, 95% confidence interval 1.208-2.318). Both groups had improved pain and quality-of-life scores. CONCLUSION: This is the first, long-term, placebo-controlled trial regarding the use of laparoscopic adhesiolysis for treating chronic abdominal pain. Laparoscopic adhesiolysis was less beneficial than laparoscopy alone in the long term. Secondly, there appeared to be a powerful, long-lasting placebo effect of laparoscopy. Because adhesiolysis is associated with an increased risk of operative complications, avoiding this treatment may result in less morbidity and health care costs.
Authors: Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson Journal: Pain Date: 2021-09-09 Impact factor: 7.926
Authors: Vânia Meira Siqueira-Campos; Mariana Siqueira Campos de Deus; Omero Benedicto Poli-Neto; Julio Cesar Rosa-E-Silva; José Miguel de Deus; Délio Marques Conde Journal: Int J Womens Health Date: 2022-02-18