|- candidate number||13245|
|- NTR Number||NTR3586|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-aug-2012|
|- Secondary IDs||12-N-79 METC Atrium-Orbis-Zuyd|
|- Public Title||Long term effects on quality of life after bile duct injury due to cholecystectomy.|
|- Scientific Title||5-year quality of life after iatrogenic bile duct injury due to cholecystectomy.|
|- ACRONYM||COBACH II|
|- hypothesis||Long term quality of life of patients with iatrogenic bile duct injury due to cholecystectomy is lower than in patients with an uncomplicated cholecystectomy.|
|- Healt Condition(s) or Problem(s) studied||Quality of life, Bile duct injury, Cholecystectomy|
|- Inclusion criteria||Both groups:|
1. Cholecystectomy in the Atrium Medical Centre Heerlen with at least five years of follow-up;
2. Age ≥18;
3. Participation in the COBACH I study (1-year quality of life).
Bile duct injury group:
1. Iatrogenic bile duct injury after cholecystectomy.
1. Uncomplicated cholecystectomy.
|- Exclusion criteria||1. Admission to another hospital due to bile duct injury;|
2. Other abdominal surgery not related to bile duct injury after cholecystectomy.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||21-aug-2012|
|- planned closingdate||31-dec-2012|
|- Target number of participants||51|
|- Interventions||1. Questionnaire: Medical Outcome Study 36-item Short Form Health Survey (SF-36);|
2. Questionnaire: Gastrointestinal Quality of Life Index (GI-QLI).
|- Primary outcome||Quality of Life:|
1. SF-36 score;
2. GI-QLI score.
|- Secondary outcome||N/A|
|- Timepoints||5 years after cholecystectomy.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| D. Dijk, van|
|- CONTACT for SCIENTIFIC QUERIES|| D. Dijk, van|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|Atrium Medical Center, Heerlen|
|- Brief summary||Background of the study:|
Bile duct injury (BDI) is a serious complication after cholecystectomy. Many studies on quality of life (QoL) after BDI have been performed in tertiary referral settings. This study investigates QoL after BDI by cholecystectomy in a large teaching hospital. Four years ago, we conducted the COBACH study which investigated the short-term QoL in patiŽnts with BDI one year after cholecystectomy. In the present study (COBACH II) we will investigate the long term QoL in the same patients at least five years after cholecystectomy.
To investigate the effect of BDI after cholecystectomy on long term QoL.
This is a retrospective study in which all patients who participated in the COBACH study will be contacted to participate. They were selected from a database of all patients who underwent a cholecystectomy between January 2003 and December 2007. Patients were divided between a BDI and a control group. Controls were randomly selected and matched on age, gender, indication, planning and operating method with the BDI group.
For this study a total of 17 BDI patients and 34 control patients will be contacted.
Adults who underwent a cholecystectomy at the Atrium Medical Center, Heerlen, the Netherlands.
All patients will be asked to fill in the Study 36-item Short Form Health Survey (SF-36) and the Gastrointestinal Quality of Life Index (GI-QLI) questionnaires. Both are recommended by the European Association for Endoscopic Surgery to assess QoL in patients with gallbladder disease. The SF-36 is a 36 item questionnaire suitable for self-administration that includes a multi-item scale (ranging from 0 to 100) which assesses eight concepts: Physical Functioning; Social Functioning; Role-Physical Functioning; Role-Emotional Functioning, Bodily Pain; Mental Health; Vitality; and General Health. It also measures Change in Health over one year, although this is not included in one of the eight subscales. In addition, the eight subscales can be clustered to calculate the Physical Component Summary (PCS) and Mental Component Summary (MCS) which each represent four of the SF-36 subscales together to get a more general idea of the patient°Įs physical and mental QoL. The GI-QLI is a system-specific questionnaire useful for self-administration to asses QoL in patients with gastro-intestinal disease. It generates an overall measurement of QoL as well as QoL in four subscales: Gastro-intestinal symptoms; physical functioning; social functioning; and emotional functioning.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study has a low burden for participating patients. A time investment of a maximum of 30 minutes has to be made to fill in and return the questionnaires. Patients do not have to come to the hospital but can return the questionnaire by mail.
There are no risks for patients participating in this study.
|- Main changes (audit trail)|
|- RECORD||19-aug-2012 - 12-sep-2012|