Twelve-year outcomes of laparoscopic adhesiolysis in patients with chronic abdominal pain: A randomized clinical trial

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.