Julia S Keckstein1,2, Simon Keckstein3,4, Kristin Brunecker5, Alexander Neugebauer5, Daniela Nüssle5, Sascha Hoffmann3, Jürgen Andress3, Felix Neis3, Marcus Scharpf3, Markus Enderle5, Ralf Rothmund3,6, Sara Y Brucker3, Martin Weiss Jun3, Bernhard Kraemer3. 1. Department of Women's Health, Tuebingen University Hospital, Calwerstr. 7, 72076, Tübingen, Germany. julia.keckstein@mailbox.org. 2. Department of Obstetrics and Gynecology, Klinikum Starnberg, Oßwaldstr. 1, 82319, Starnberg, Germany. julia.keckstein@mailbox.org. 3. Department of Women's Health, Tuebingen University Hospital, Calwerstr. 7, 72076, Tübingen, Germany. 4. Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Marchioninistr. 15, 81377, Munich, Germany. 5. Erbe Elektromedizin GmbH, Waldhoernlestr. 17, 72072, Tübingen, Germany. 6. Praxis Im Frauenzentrum Lindenhofspital, 3012, Bern, Switzerland.
Abstract
PURPOSE: Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC. METHODS: In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate. RESULTS: The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p < .05). No intra- and postoperative complications were registered. CONCLUSION: This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.
PURPOSE: Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC. METHODS: In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate. RESULTS: The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p < .05). No intra- and postoperative complications were registered. CONCLUSION: This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.
Authors: Tal Z Jacobson; James M N Duffy; David H Barlow; Cindy Farquhar; Philippe R Koninckx; David Olive Journal: Cochrane Database Syst Rev Date: 2014-08-18
Authors: Patrick F Vetere; George Lazarou; Radu Apostol; Poonam Khullar; Linda Okonkwo; Farr Nezhat Journal: JSLS Date: 2015 Apr-Jun Impact factor: 2.172