Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial.

Pilot and Feasibility Studies
M S BajwaA G Schache

Abstract

Complications after major surgery are a significant cause of morbidity and mortality. Neck dissection is one of the most commonly performed major operations in Head and Neck Surgical Oncology. Significant surgical complications occur in approximately 10-20% of all patients, increasing to 40% in patients who have had previous treatment to the area or have multiple co-morbidities and/or polypharmacy.Current evidence suggests that fibrin sealants (FS) may have potential clinical advantages in Head and Neck Surgery through the reduction of complications, volume of wound drainage and retention time of the drains. However, a paucity of high-quality trial-based evidence means that a surgical trial to determine the effectiveness of FS in reducing the rate and severity of complications in patients undergoing lateral neck dissection is warranted. The DEFeND randomised external pilot trial will address critical questions on how well key components of the proposed study design work together as well as the feasibility of a future phase III trial. The study design that is being piloted is that of a two-arm, parallel group, superiority trial with block randomisation in a 1:1 allocation ratio. The interventional arm will constitute the applica...Continue Reading

References

Jan 12, 2002·Archives of Otolaryngology--head & Neck Surgery·Rodney J TaylorDouglas B Chepeha
Jul 16, 2002·Archives of Otolaryngology--head & Neck Surgery·K Thomas RobbinsUNKNOWN American Academy of Otolaryngology--Head and Neck Surgery
Feb 1, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jenny HuangWilliam J Mackillop
May 3, 2013·The Oncologist·Noam A VanderWaldeBhishamjit S Chera
Mar 19, 2014·The British Journal of Surgery·R S R WoodsC Timon
Dec 4, 2014·Clinical Otolaryngology : Official Journal of ENT-UK ; Official Journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery·S A R NouraeiA Bottle
Feb 5, 2015·Health and Quality of Life Outcomes·Julien MaillardBernhard Walder
Jul 15, 2015·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·Che-Wei HuangShih-An Liu
Mar 24, 2016·The New England Journal of Medicine·Hisham MehannaUNKNOWN PET-NECK Trial Management Group
Nov 28, 2017·Clinical Otolaryngology : Official Journal of ENT-UK ; Official Journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery·B G MainJ M Blazeby

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Methods Mentioned

BETA
dissection
dissections
TARDIS

Clinical Trials Mentioned

ISRCTN99181100

Software Mentioned

MACRO
DEFeND
Treatment Allocation RanDomIsation System ” ( TARDIS )
SPIRIT
TARDIS

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