Plain English Summary
Background and study aims
Weight loss surgery, also called bariatric or metabolic surgery, is sometimes used as a treatment for people who are very obese. It can lead to significant weight loss and help improve many obesity-related conditions, such as type 2 diabetes or high blood pressure. But it's a major operation and in most cases should only be considered after trying to lose weight through a healthy diet and exercise.
This study aims to test the safety of a new procedure that combines elements of existing procedures.
Who can participate?
Patients aged over 18 and below 65 years with BMI over 40 kg/m² (without comorbidity related to morbid obesity) or 35 kg/m² (with comorbidity related to morbid obesity, especially glucose metabolism)
What does the study involve?
Patient assessment, performing surgery, and follow up at 1, 3, 6 and 12 months postoperatively.
What are the possible benefits and risks of participating?
Favourable weight loss management is expected due to reducing stomach volume and duodeno-jejunal exclusion but operations may have some risks (gastric wall prolapse, leakage, stricture, bleeding, bile reflux, vomiting, diarrhea, hair loss, nutrient deficiency, hypoproteinaemia and anaemia due to malabsorption)
Where is the study run from?
Kanizsai Dorottya Hospital (Hungary)
When is the study starting and how long is it expected to run for?
October 2018 to October 2020
Who is funding the study?
Kanizsai Dorottya Hospital (Hungary)
Who is the main contact?
Dr Istvan Bence Balint, balint.istvan.bence@kmmk.hu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Istvan Bence Balint
ORCID ID
https://orcid.org/0000-0002-2066-861X
Contact details
Erkel Ferenc
1/1/3
Nagykanizsa
8800
Hungary
+36 82501300/6238
balint.istvan.bence@kmmk.hu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KDK-2071-2/2019
Study information
Scientific title
LAparoscopic Single-Anastomosis duodeno-ileal bypass with Gastric plication (SADI-GP) in the maNagEment of morbid obesity (LASAGNE)
Acronym
LASAGNE
Study hypothesis
Laparoscopic single-anastomosis duodeno-ileal bypass with gastric plication is expected to be a safe procedure and have low complication rates and favourable weight loss outcomes.
Ethics approval
Approved 05/07/2019, Kanizsai Dorottya Hospital (Hospital of Nagykanizsa) Institutional Review Board (8800, Nagykanizsa, Szekeres, J.u. 2-8, Hungary; +36 93502092; titkarsag@nkkorhaz), ref: KDK-2071-2/2019
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Laparoscopic surgery for severe obesity and related metabolic disorders
Intervention
Patients were operated on to perform laparoscopic single anastomosis duodeno-ileal bypass with gastric plication. Follow-ups were at 1, 3 and 6 months and are planned at 12 months.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Postoperative complications (gastric wall prolapse, leakage, stricture, bleeding, bile reflux, vomiting, diarrhea, hair loss, nutrient deficiency, hypoproteinaemia and anaemia due to malabsorption, venous thromboembolism, pulmonary and cardiovascular events, 30-day hospital readmission) were classified by Clavien-Dindo
Secondary outcome measures
At follow up visits (1,3,6 and 12 months), patients were assessed again by physical examination, blood tests (blood count, ionogram, serum protein, glucose, HgbA1C, iron binding capacity, lipid profile, kidney and liver function, hemostasis) and BAROS-Moorehead-Ardelt II and Weiner et al. questionnaires. Weight, BMI adjusted to age-gender-ethnics, ideal weight (at BMI: 25), excess of weight, excess of BMI, weight loss, EWL% and TWL% were measured as weight loss outcomes
Overall trial start date
16/10/2018
Overall trial end date
29/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age over 18 and below 65 years
2. BMI over 40 kg/m² (without comorbidity related to morbid obesity) or 35 kg/m² (with comorbidity related to morbid obesity, especially glucose metabolism)
3. Patient agreement for follow-ups
4. Obtained informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35
Total final enrolment
36
Participant exclusion criteria
1. Bariatric surgery in previous history
2. Severe mental disorders (drug addiction, alcohol consumption, the use of antipsychotics)
3. Socially vulnerable patients
4. Complete immobilization
5. Patients who did not understand the purpose of the study and bariatric surgery
Recruitment start date
16/10/2018
Recruitment end date
30/06/2019
Locations
Countries of recruitment
Hungary
Trial participating centre
Kanizsai Dorottya Hospital
Szekeres Jozsef street 2-8.
Nagykanizsa
8800
Hungary
Sponsor information
Organisation
Kanizsai Dorottya Hospital
Sponsor details
Szekeres Jozsef street 2-8
Nagykanizsa
8800
Hungary
+36 93502000
titkarsag@nkkorhaz.hu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Kanizsai Dorottya Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
30/10/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12800723_PROTOCOL_27May2020.pdf Uploaded 08/06/2020