Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicentre, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery
| Autor: | R. DeWilde, G. Pados, A.M. Lower, Alex McConnachie, A. D. Knight, P. Konincxk, Maria Elisabetta Coccia, Alison M. Crowe, Enda McVeigh, Jean-Luc Pouly, G. Pistofidis, T. Röemer, Alain Audebert, Michel Degueldre, Geoffrey Trew, Liselotte Mettler, S. Rimbach, Diethelm Wallwiener, Ellen M. Schmidt, D. Dallay, Charles Chapron, Ian Ford, Matthias Korell, S. Landi, Gere S. diZerega, Carmine Nappi |
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| Přispěvatelé: | Trew, G., Pistofidis, G., Pados, G., Lower, A., Mettler, L., Wallwiener, D., Korell, M., Pouly, J. L., Coccia, M. E., Audebert, A., Nappi, Carmine, Schmidt, E., Mcveigh, E., Landi, S., Degueldre, M., Konincxk, P., Rimbach, S., Chapron, C., Dallay, D., Roemer, T., Mcconnachie, A., Ford, I., Crowe, A., Knight, A., Dizerega, G., Dewilde, R. |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Laparoscopic surgery icodextrin medicine.medical_specialty Adolescent medicine.medical_treatment Video Recording Adhesion (medicine) Tissue Adhesions Icodextrin law.invention Gynecologic Surgical Procedures Randomized controlled trial law medicine Humans Therapeutic Irrigation Laparoscopy Glucans medicine.diagnostic_test business.industry Rehabilitation Icodextrin Solution Obstetrics and Gynecology Myoma medicine.disease Uterine myomectomy Surgery Glucose Reproductive Medicine Second-Look Surgery Female business |
| Popis: | Gynaecological laparoscopic surgery outcomes can be compromised by the formation of de novo adhesions. This randomized, double-blind study was designed to assess the efficacy and safety of 4% icodextrin solution (Adept(®)) in the reduction of de novo adhesion incidence compared to lactated Ringer's solution (LRS).Patients undergoing laparoscopic surgery for removal of myomas or endometriotic cysts were treated with randomized solution as an intra-operative irrigant and 1l post-operative instillate. De novo adhesion incidence (number of sites with adhesions), severity and extent were independently scored at a second-look procedure and the efficacy of the two solutions compared. The effect of surgical covariates on adhesion formation was also investigated. Initial exploratory analysis of individual anatomical sites of clinical importance was progressed. RESULTS Of 498 patients randomized, 330 were evaluable (160 LRS--75% myomectomy/25% endometriotic cysts; 170 Adept--79% myomectomy/21% endometriotic cysts). At study completion, 76.2% LRS and 77.6% Adept had ≥ 1 de novo adhesion. The mean (SD) number of de novo adhesions was 2.58 (2.11) for Adept and 2.58 (2.38) for LRS. The treatment effect difference was not significant (P = 0.909). Assessment of surgical covariates identified significant influences on the mean number of de novo adhesions regardless of treatment, including surgery duration (P = 0.048), blood loss in myomectomy patients (P = 0.019), length of uterine incision in myomectomy patients (P0.001) and number of suture knots (P0.001). There were 15 adverse events considered treatment-related in the LRS patients (7.2%) and 18 in the Adept group (8.3%). Of 17 reported serious adverse events (9 LRS; 8 Adept) none were considered treatment-related.The study confirmed the safety of Adept in laparoscopic surgery. The proportion of patients with de novo adhesion formation was considerably higher than previous literature suggested. Overall there was no evidence of a clinical effect but various surgical covariates including surgery duration, blood loss, number and size of incisions, suturing and number of knots were found to influence de novo adhesion formation. The study provides direction for future research into adhesion reduction strategies in site specific surgery. |
| Databáze: | OpenAIRE |
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