Outcomes of bariatric surgery in patients with liver cirrhosis
| ISRCTN | ISRCTN15009106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15009106 |
| Secondary identifying numbers | IIBSP-BAR-2016-108 |
- Submission date
- 17/05/2017
- Registration date
- 26/05/2017
- Last edited
- 12/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Cirrhosis occurs when the liver becomes scarred due to long-term damage. It can stop the liver from working properly, causing liver failure. A main risk factor for liver cirrhosis is from being obese or overweight. When people are obese, they sometimes undergo a weight loss surgery called bariatric surgery. This is a major operation that either removes a part of stomach or puts a band over it so that patients feel full. It can help reduce the chances of liver cirrhosis, among many other obesity related conditions. The aim of this study is to analyse the effects of obesity surgery in patients with liver cirrhosis to see if patients with liver cirrhosis that undergo the surgery have different complication rates, if they surgery is effective with weight loss and if it helps improve liver function.
Who can participate?
Adults aged 18 to 70 with obesity and liver cirrhosis who had bariatric surgery
What does the study involve?
Participants who have undergone a bariatric surgery are included in this study and have their medical records reviewed. Data is reviewed before and their surgery to see if they had any complications, to review their weight and height, compare blood analyses, and to see if their liver function has improved.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.
Where is the study run from?
This study is taking place in 19 hospitals in Spain
When is the study starting and how long is it expected to run for?
January 2017 to March 2018
Who is funding the study?
Organisation Spanish Society of Endocrinology and Nutrition (SEEN) (Spain)
Who is the main contact?
Dr Inka Miñambres
iminambres@santpau.cat
Contact information
Scientific
Endocrinology Services
Hospital de la Santa Creu i Sant Pau
C/ Mas Casanovas 90
Barcelona
08026
Spain
| Phone | +34 (0)93 55 65 661 |
|---|---|
| iminambres@santpau.cat |
Study information
| Study design | Observational multi-centre retrospective case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | BARiatric surgery in patients with liver CIRRhOsis |
| Study acronym | CIRROBAR |
| Study objectives | The aim of this study is to assess short and long-term evolution and complications of patients with liver cirrhosis and obesity that are submitted to obesity surgery in Spain. |
| Ethics approval(s) | Ethics Committee of the Research Institute of Hospital de la Santa Creu i Sant Pau – IIB Sant Pau, 01/03/2017, ref: IIBSP-BAR-2016-108 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | This is a retrospective study. Participants are included for this study if they already have had a bariatric surgery and have been followed up since the surgery date until the inclusion data in the study by their endocrinology team. Eligible participants have clinical and analytical data collected from their baseline visit prior to surgery. Then, participants undergo the surgery and then have their routine follow up visits. The number of follow up visits differs from one patient to another according to their date of surgery. Data is collected yearly from when the surgery occurred until the present. The data collected from participants include age, date of surgery, type of surgery, weight, height and BMI, presence of diabetes, cause of cirrhosis, hepatic biopsa, blood tests, and any complications they may have. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Short and long term evolution of patients with liver cirrhosis submitted to obesity surgery is measured using patient records at 1 month and one year after bariatric surgery and for long term evolution, at the last visit in each patient |
| Secondary outcome measures | 1. Causes of cirrhosis, staging (Child, MELD) and degree of hepatic insufficiency (albumin, platelets, INR, liver function tests) are measured using patient records at the last pre-surgical visit 2. Hepatic pathology after bariatric surgery (staging (Child, MELD), degree of liver failure (albumin, platelets, INR, liver function tests), liver biopsies, hepatic decompensations postIQ (encephalopathy, ascites, Bleeding), development of hepatocarcinoma)) are measured using patient records at the patients last follow up visit 3. Frequency of early complications are measured using patient records at early postoperative (<30 days post surgery) or late (> 30 days post surgery) 4. Obesity comorbidities (diabetes, hypertension, dyslipidemia, SAHS) are measured using patient records at the last pre-surgical visit and at each year after surgery until study inclusion 5. Body weight is measured using patient records at the last pre-surgical visit and at each year after surgery until study inclusion |
| Overall study start date | 01/01/2017 |
| Completion date | 01/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Minimum of 30 pacients |
| Key inclusion criteria | 1. Patient with obesity and liver cirrhosis submitted to bariatric surgery in Spain 2. Aged 18 to 70 years old |
| Key exclusion criteria | Not applicable |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 01/12/2017 |
Locations
Countries of recruitment
- Spain
Study participating centres
89
Barcelona
08026
Spain
25-29
Barcelona
08003
Spain
80
Lleida
25198
Spain
14004
Córdoba
14004
Spain
119-129
Barcelona
08035
Spain
Sabadell
Barcelona
08208
Spain
15006 A Coruña
La Coruña
15006
Spain
S/N
Málaga
29010
Spain
46
Madrid
28007
Spain
36
31008
Navarra
Pamplona
31008
Spain
170
Barcelona
08036
Spain
s/n
León
24001
Spain
Polígono de Riaño
1
Langreo
33920
Spain
341
Vigo Pontevedra
Vigo
36312
Spain
s/n
Madrid
28040
Spain
s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Sevilla
41013
Spain
s/n
Málaga
29010
Spain
08916 Badalona
Barcelona
08916
Spain
Sponsor information
Research organisation
c/Villalar 7 Bajo-interior Derecha
Madrid
28001
Spain
| Phone | +34 (0)914 313 294 |
|---|---|
| secretaria@seen.es | |
| Website | www.seen.es |
"ROR" |
https://ror.org/01tk4y529 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | 12/03/2019 | Yes | No |
Editorial Notes
12/03/2019: Publication reference added.
10/08/2017: Internal review.
