Study on frail patients undergoing elective and emergency cholecystectomy

ISRCTN ISRCTN14976998
DOI https://doi.org/10.1186/ISRCTN14976998
Secondary identifying numbers N/A
Submission date
30/06/2016
Registration date
06/07/2016
Last edited
30/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The gallbladder is a small, pouch-like organ found underneath the liver, which is responsible for storing bile (a chemical produced by the liver which helps with the digestion of fats) and making it more concentrated. In some cases, if there is too much cholesterol in the bile inside gallbladder, it can lead to the development of small stones (gallstones). In some cases gallstones can be very painful and it may be necessary for the gallbladder to be surgically removed. Older patients experience more complications after gallbladder removal compared with younger patients. However, most studies have not considered patient frailty, particularly in patients who undergo emergency gallbladder removal. The aim of this study is to find out whether there is a link between frailty and poor surgical outcomes (complications and death).

Who can participate?
Patients aged 65 and over who have gallstones who are scheduled for a routine or emergency gallbladder removal.

What does the study involve?
All patients are assessed using the Geriatric Assessment (GA) on the day that they are admitted to hospital. This includes a range of questionnaires and tests designed to evaluate the patient’s physical and emotional functionality as well as their nutritional status and the medications they take, so that their frailty can be determined. Participants then undergo their surgery as per standard practice and are followed up for thirty days so that any complications or death after surgery can be recorded, as well as the length of their hospital stay. This information is then compared with the results of the GA in order to look at the link between frailty and surgical outcomes.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
3rd Department of General Surgery, Jagiellonian University Medical College (Poland)

When is the study starting and how long is it expected to run for?
January 2013 to March 2015

Who is funding the study?
3rd Department of General Surgery, Jagiellonian University Medical College (Poland)

Who is the main contact?
Dr Jakub Kenig
jkenig@cm-uj.krakow.pl

Contact information

Dr Jakub Kenig
Scientific

)3rd Department of General Surgery
Jagiellonian Univeristy Medical College
Pradnicka str. 35-37
Krakow
21-202
Poland

Phone +48 126 331 995
Email jkenig@cm-uj.krakow.pl

Study information

Study designObservational case series
Primary study designObservational
Secondary study designCase series
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleGeriatric assessment as a qualification element for elective and emergency cholecystectomy in older patients
Study objectives1. Frail patients who have qualified for an elective cholecystectomy can be safely operated upon
2. Frail patients who have qualified for an emergency cholecystectomy have higher postoperative morbidity and mortality
Ethics approval(s)Jagiellonian University Medicall College approved the study, 22/05/2014, ref: KBET/128/B/2014
Health condition(s) or problem(s) studiedCholecystitis
InterventionAll included patients will be assessed using the Geriatric Assessment, which will be performed on the day of admission by trained physicians or, for emergency patients, by trained physicians or nurses. The GA comprises the validated instruments evaluating functional (Activities of Daily Living - ADL, Instrumental Activities of Daily Living - I-ADL), cognitive (Blessed Orientation-Memory-Concentration Test - BOMC and Clock Drawing Test - CDT), depressive (Geriatric Depression Scale - GDS), nutritional (Mini Nutritional Assessment - MNA) and polypharmacy status (number of drugs taken by the patient) with the range and the literature-based cut-off scores. A cumulative deficit model of frailty will be used. The equally weighted deficits, as a measure of accumulated vulnerability, included ADL/IADL, Geriatric Depression Score, BOMC/CDT, the Mini-Nutritional Assessment, CCS, and the Polypharmacy Assessment. The functional (ADL/IADL) and cognitive domains (BOMC/CDT) will be considered abnormal if one of the assessment tools showed literature-based impairment. The detection of deficits in two or more GA domains indicates an increased risk of disability or death and is used as the cut-off score for the GA set and also as the definition of frailty.

Participation in the study does not change anything in the treatment plan, surgery and postoperative rehabilitation. Enrolled patients will undergo elective/emergency laparoscopic or open cholecystectomy (decision of the surgeon and anesthesiologist). All operations will be performed by residents under the direct supervision of a consultant (who also served as the first assistant) or by the consultants themselves. Laparoscopic cholecystectomy will be performed using a standard three- or four-port technique and all emergency patients were treated surgically within 24 h after admission. Severity grading for the acute cholecystitis patients is according to the 2013 Tokyo Guidelines. The postoperative follow-up regarding postoperative morbidity and mortality will last for 30-days.
Intervention typeOther
Primary outcome measure1. Post-operative complications, defined as any event occurring within 30 days of surgery that required treatment not routinely applied in the post-operative period, is measured through telephone interviews and clinic visits at 30 days post-surgery
2. Post-operative mortality, defined as death within 30 days after surgery, is measured using review of medical records or contact with the appropriate registry office
Secondary outcome measuresLength of hospital stay, defined as the time between the day of admission until discharge from hospital, is measured through medical record review.
Overall study start date01/01/2013
Completion date01/03/2015

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants60 elective and emergency patients
Total final enrolment126
Key inclusion criteriaElective patients:
1. Age 65 years or older
2. Symptomatic and sonographically detected cholelithiasis
3. Qualified for elective cholecystectomy (symptomatic and sonographically detected cholelithiasis without any signs of inflammation)
4. Provision of informed consent to participate

Emergency patients:
1. Age 65 years or older
2. Acute cholecystitis according to the 2013 Tokyo Guidelines
3. Qualified for emergency cholecystectomy (acute cholecystitis according to the 2013 Tokyo Guidelines operated within 24 hours after admission to the surgical department)
4. Provision of informed consent to participate
Key exclusion criteria1. Patients with pancreatitis
2. No consent at the time of surgery
Date of first enrolment22/05/2014
Date of final enrolment15/12/2015

Locations

Countries of recruitment

  • Poland

Study participating centre

Jagiellonian University Medical College
3rd Department of General Surgery
Pradnicka str. 35-37
Kraków
31-202
Poland

Sponsor information

3rd Department of General Surgery Jagiellonian University Medical College
Hospital/treatment centre

Pradnicka 35-37
Krakow
31-202
Poland

ROR logo "ROR" https://ror.org/03bqmcz70

Funders

Funder type

Hospital/treatment centre

3rd Department of General Surgery Jagiellonian University Medical College

No information available

Results and Publications

Intention to publish date30/09/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/07/2016 30/11/2020 Yes No

Editorial Notes

30/11/2020: Publication reference and total final enrolment added.