Universität zu Köln

Grosheva, Maria, Klussmann, Jens Peter ORCID: 0000-0002-8223-7954, Beutner, Dirk, Formanek, Michael, Lill, Claudia, Laskawi, Rainer, Zenk, Johannes, Pick, Carina, Erlacher, Birgit, Bemmer, Julian, Thielker, Jovanna, Jering, Monika, Tostmann, Ralf and Guntinas-Lichius, Orlando ORCID: 0000-0001-9671-0784 (2021). Planning and design of European prospective randomized trial on the value of drain in parotidectomy. Laryngo-Rhino-Otol., 100 (1). S. 47 - 55. STUTTGART: GEORG THIEME VERLAG KG. ISSN 1438-8685

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Abstract

Introduction There are no valid clinical studies on the value of wound drains in parotid surgery. The aim of the current trial is to analyze the influence of the closed wound drain (redon) on the incidence of postoperative complications such as bleeding, wound healing problems, infection, as well as salivary cyst and fistula after superficial or partial parotidectomy. Methods A European-wide multicenter prospective randomized study was planned. The study protocol was prepared by the leading study center (ENT University Hospital Cologne) in cooperation with the ENT University Hospitals Jena and Gottingen. The calculation of the number of cases was carried out with G*Power. The study includes test persons with an indication for parotidectomy for a benign tumor without known coagulation disorder or ongoing anticoagulation. Preoperative randomization and data management is software-supported (REDCap 9.1.24, Vanderbilt University). Results The study has been approved by the leading ethics committee in 10/2019 and is open since 04/2019. Currently, nine (9) ENT hospitals are participating in the study, 6 of them in Germany and 3 in Austria. Enrollment of patients is ongoing in 7 centers. With a calculated follow-up-to-treat population of 800 test persons, the planned duration of the study is 4 years. Conclusions The Redon-study is the first prospective randomized study worldwide to investigate the effect of a drain in parotidectomy. In order to achieve the recruitment goal within the planned time frame, the participation of further specialized study centers is needed. We also encourage all ENT physicians to make their patients aware of the Redon study, inform them about the possibility of participating in the study and refer them to one of the participating centers.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Grosheva, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Klussmann, Jens Peter UNSPECIFIED orcid.org/0000-0002-8223-7954 UNSPECIFIED Beutner, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Formanek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Lill, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Laskawi, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Zenk, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Pick, Carina UNSPECIFIED UNSPECIFIED UNSPECIFIED Erlacher, Birgit UNSPECIFIED UNSPECIFIED UNSPECIFIED Bemmer, Julian UNSPECIFIED UNSPECIFIED UNSPECIFIED Thielker, Jovanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Jering, Monika UNSPECIFIED UNSPECIFIED UNSPECIFIED Tostmann, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Guntinas-Lichius, Orlando UNSPECIFIED orcid.org/0000-0001-9671-0784 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-592464
DOI:	10.1055/a-1178-0800
Journal or Publication Title:	Laryngo-Rhino-Otol.
Volume:	100
Number:	1
Page Range:	S. 47 - 55
Date:	2021
Publisher:	GEORG THIEME VERLAG KG
Place of Publication:	STUTTGART
ISSN:	1438-8685
Language:	German
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SUPERFICIAL PAROTIDECTOMY; POSTOPERATIVE DRAINAGE; SURGERY; TUMORS; GLAND; HEAD Multiple languages Otorhinolaryngology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59246