Condition category
Surgery
Date applied
24/05/2020
Date assigned
29/05/2020
Last edited
08/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

https://www.nkkorhaz.hu/

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

Editorial Notes

08/06/2020: Uploaded protocol, 27 May 2020 (not peer reviewed). 29/05/2020: Internal review. 27/05/2020: Trial’s existence confirmed by Kanizsai Dorottya Hospital.