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Bridging of upper part of small bowel with stomach tubing for facilitating weight loss of morbidly obese patients

LAparoscopic Single-Anastomosis duodeno-ileal bypass with Gastric plication (SADI-GP) in the maNagEment of morbid obesity (LASAGNE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12800723
Enrollment
35
Registered
2020-05-29
Start date
2018-10-16
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic surgery for severe obesity and related metabolic disorders Surgery

Interventions

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.

Sponsors

Kanizsai Dorottya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Hungary

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026