Abstract
BackgroundTo 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% CO2+ 10% N2O + 4% O2 for the pneumoperitoneum, cooling of the peritoneal cavity, humidification, heparinized rinsing solution and 5 mg of dexamethasone as demonstrated in animal models.MethodsA 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 CO2 resorption, postoperative pain and recovery. Randomization was performed after signing informed consent. Adhesion scoring during second look laparoscopy and pain scoring were done blindly.ResultsIn 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 CO2 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 conclusionThis translational research confirms in the human the efficacy of FC in reducing CO2 resorption and adhesions with in addition less postoperative pain, lower postoperative CRP concentrations and an accelerated recovery.
Highlights
To translate the concept of full-conditioning (FC) from animal experiments to the human, and to evaluate the efficacy for adhesion prevention
Beneficial factors are the addition to the pneumoperitoneum of more than 5% of N2O [22,23], cooling [24,25] of the peritoneal cavity making cells more resistant to trauma, the addition of dexamethasone [26], and the addition of some 4% of O2 to the CO2 pneumoperitoneum restoring a partial oxygen pressure of 28 mm of Hg [18,27]
Adhesions before surgery were comparable in both groups, except for adhesions between uterus and rectum which were slightly higher in the control group (Figure 2). This could not be explained by a different incidence of adhesions before surgery (11/16 versus 9/11 respectively), by a different incidence of previous interventions (6/16 versus 4/11) nor by the severity or size of the deep endometriosis, nor by the presence or size of cystic ovarian endometriosis, nor by the rAFS score, we consider this as a spurious significance caused by the small groups
Summary
To translate the concept of full-conditioning (FC) from animal experiments to the human, and to evaluate the efficacy for adhesion prevention. Our group (for review [11,12]) demonstrated in animal models, rabbits and mainly in a laparoscopic mouse model that peritoneal conditioning decreases CO2 resorption during surgery [13,14] and the severity of acute inflammation in the entire peritoneal cavity [15] which enhances adhesion formation at surgical trauma sites. This enhancement is mediated by humoral factors in peritoneal fluid since touching small bowels in the upper abdomen [16] can increase adhesions in the lower abdomen. The former decreases acute inflammation in the entire peritoneal cavity while the latter keeps trauma sites separated
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