Bridging of upper part of small bowel with stomach tubing for facilitating weight loss of morbidly obese patients
| ISRCTN | ISRCTN12800723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12800723 |
| Secondary identifying numbers | KDK-2071-2/2019 |
- Submission date
- 24/05/2020
- Registration date
- 29/05/2020
- Last edited
- 04/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Erkel Ferenc
1/1/3
Nagykanizsa
8800
Hungary
 ORCID ID |
0000-0002-2066-861X |
|---|---|
| Phone | +36 82501300/6238 |
| balint.istvan.bence@kmmk.hu |
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | LAparoscopic Single-Anastomosis duodeno-ileal bypass with Gastric plication (SADI-GP) in the maNagEment of morbid obesity (LASAGNE) |
| Study acronym | LASAGNE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 16/10/2018 |
| Completion date | 29/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 35 |
| Total final enrolment | 36 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/10/2018 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Nagykanizsa
8800
Hungary
Sponsor information
Hospital/treatment centre
Szekeres Jozsef street 2-8
Nagykanizsa
8800
Hungary
| Phone | +36 93502000 |
|---|---|
| titkarsag@nkkorhaz.hu | |
| Website | https://www.nkkorhaz.hu/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 27/05/2020 | 08/06/2020 | No | No | |
| Results article | 17/08/2021 | 04/03/2022 | Yes | No |
Additional files
- ISRCTN12800723_PROTOCOL_27May2020.pdf
- Uploaded 08/06/2020
Editorial Notes
04/03/2022: Publication reference added.
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.
