Peritoneal full-conditioning reduces postoperative adhesions and pain: a randomised controlled trial in deep endometriosis surgery

BACKGROUND: To translate the concept of full-conditioning (FC) from animal experiments to the human, and to evaluate the efficacy for adhesion prevention. FC consisted of decreasing acute inflammation by 86% CO(2)+ 10% N(2)O + 4% O(2) for the pneumoperitoneum, cooling of the peritoneal cavity, humidification, heparinized rinsing solution and 5 mg of dexamethasone as demonstrated in animal models. METHODS: A randomized controlled trial (RCT: NCT01344486) comparing standard laparoscopy with full conditioning together with a barrier in a 2/3 ratio in 44 women undergoing deep endometriosis surgery at KULeuven. The primary aim was reduction of adhesions. Secondary aims were CO(2) resorption, postoperative pain and recovery. Randomization was performed after signing informed consent. Adhesion scoring during second look laparoscopy and pain scoring were done blindly. RESULTS: In the FC group (n = 16) adhesions were completely prevented in 12/16 women whereas in the control group (n = 11) all women had severe adhesions (P < 0.0005). Also the area, density and severity of adhesions were less. (P <0.001). In the control group, severity, density and area of adhesions were strongly interrelated (P = 0.0001 for all areas) suggesting a common enhancing factor. In the FC group CO(2) resorption (P < 0.001), postoperative pain (P < 0.001), and CRP concentrations (P < 0.01) were lower while clinical recovery was faster (P < 0.0001) and time to first flatus (P < 0.002) shorter. IN CONCLUSION: This translational research confirms in the human the efficacy of FC in reducing CO(2) resorption and adhesions with in addition less postoperative pain, lower postoperative CRP concentrations and an accelerated recovery.