|- candidate number||21386|
|- NTR Number||NTR4943|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jan-2015|
|- Secondary IDs||METC 2014-73 |
|- Public Title||Eating water ice-cream in the recovery room after bariatric surgery and the effect on quality of recovery|
|- Scientific Title||Eating water ice-cream in the recovery room after bariatric surgery and the effect on quality of recovery
|- hypothesis||We hypothesize that offering patient after general surgery water ice cream will reduce the side effects of sore throat and foul smell and in general increase the quality of recovery. |
|- Healt Condition(s) or Problem(s) studied||Sore throat, Recovery, Foul smell|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria: Adult patients who underwent elective bariatric procedure and are willing/able to eat water ice cream 30-60 min after surgery.|
|- Exclusion criteria||Patients who are not stable after surgery
Patients admitted for re-operation within one week, emergency patients.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||2-feb-2015|
|- planned closingdate||27-mrt-2015|
|- Target number of participants||172|
|- Interventions||Offering water ice cream after bariatric surgery (rocket ice cream)|
|- Primary outcome||Reduce sore throat and foul smell after general anaesthesia|
|- Secondary outcome||Scoring on the Quality of Recovery QoR-40 Questionnaire.|
|- Timepoints||30-60 days|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Ph.D. Pieter Stepaniak |
|- CONTACT for SCIENTIFIC QUERIES||Ph.D. Pieter Stepaniak |
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Budget Operating Room Department, Catharina Hospital, Eindhoven The Netherlands|
|- Publications||McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53
Bathala S, Eccles R. A review on the mechanism of sore throat in tonsillitis. J Laryngol Otol. 2013 Mar;127(3):227-32
Agarwal A, Gupta D, Yadav G, Goyal P, Singh PK, Singh U. An evaluation of the efficacy of licorice gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Anesth Analg. 2009 Jul;109(1):77-81|
|- Brief summary||A lot of times the anaesthesia used during surgery leaves a foul taste in the mouth and a sore throat as side effect. Recently a hospital announced that they give patients ice cream after surgery because “it improves the wellbeing of the patient after recovery”. It seemed that this conclusion was not based after any rigid scientific research but on observations only.
Patients who underwent surgery after general anaesthesia postoperative mostly complain about a sore throat and a foul taste. The sore throat is caused by the intubation and the foul smell is caused by the anaesthesia damps. Careful insertion techniques for both the tracheal tube and laryngeal mask are of importance in the prevention of airway trauma and postoperative sore throat
Despite this, the problems of sore throat and foul smell still is a complaint of many patients.
After a search in PubMed we did not find any study describing the effect of ice on the quality of recovery. Only the use of ice after tonsillectomy is described.
We hypothesize that offering patient after bariatric surgery water ice cream will reduce the side effects of sore throat and foul smell and in general increase the quality of recovery.
|- Main changes (audit trail)|
|- RECORD||8-jan-2015 - 25-apr-2015|