Clinical trial NCT05334173: Gastric Bypass With Different Lengths of the Bilipancreatic Limb
Official title: Randomized Clinical Trial on the Outcome of Gastric Bypass With Biliopancreatic and Alimentary Limbs of 150 Centimeters (cm)/70 cm Versus(vs) 70/150 cm, Measuring the Length of the Common Limb
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laparoscopic-Roux-en-Y Gastric Bypass
Obesity
Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Sleep Apnea
Keywords: Diabetes Mellitus, Type 2
Hypertension
Dyslipidemia
Obstructive Sleep Apnea Syndrome
Quality of life
Nutritional deficit
Laparoscopic-Roux-en-Y-Gastric-Bypass
Biliopancreatic limb
Alimentary limb
Common limb
Lead sponsor: Hospital Universitario de Fuenlabrada
Sponsor class: OTHER
Collaborators: name: Spanish Association of Surgeons (AEC)
First posted: 2022-04-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial in blocks (1:1). Type 1 laparoscopic Gastric Bypass (150cm alimentary limb and 70cm biliopancreatic limb) or type 2 laparoscopic Gastric Bypass (70cm alimentary limb and 150cm biliopancreatic limb)
Primary purpose: TREATMENT

Brief summary: Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. However, more than 25% of patients do not obtain the expected result.

There is no uniform technique to perform a LRYGB, but traditionally it was constructed using a long alimentary limb (AL) and a short biliopancreatic limb (BPL). There is no current consensus on the ideal length of the LRYGB limbs.

The distal gastric bypass at the expense of a longer biliopancreatic limb (LBPL-GB) could induce more excess of weight loss (EWL%), but with possible protein malnutrition depending on the length of the remaining common limb.

The aim of this study is compare a LBPL-GB (BPL 150cm, AL 70cm) with LAL-GB (BPL 70cm, AL 150cm).

PRIMARY OUTCOME: to evaluate if there are differences in weight loss. SECONDARY OUTCOME: to assess whether there are differences in both groups in remission of the most common comorbidities and in quality of life.

DESIGN: multicenter, prospective, randomized study in blocks (1:1), blinded for the patient and to the surgeon up to the time of intervention, in patients with indication of RYGB for obesity (BMI\>35 with associated comorbidity or BMI\>40 with or without comorbidity, excluding those of BMI\>50). Intervention: LRYGB type 1 (LAL-GB: 150cm ALand 70cm BPL) or type 2 (LBPL-GB: 70cm AL and 150cm BPL).

The expected result is that the patients with LBPL-GB present better EWL%, and higher remission of their comorbidities than the comparison group


Eligibility criteria: Inclusion Criteria:

* Patients with BMI 35-40 kg/m2 with associated medical problems (Diabetes Mellitus, Hipertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome) or 40-50 kg/m2 with or without associated medical problems, who comply with the regulatory rules for bariatric surgery in Spain (SECO and AEC)

Exclusion Criteria:

* General contraindications to kind of surgery
* BMI \> 50 kg/m2
* Known drug or alcohol abuse
* ASA (American Society of Anesthesiology) physical status classification \> III
* Inability to follow the procedures of the study

Primary outcomes:
measure: Excess Weight Loss (%EWL)
timeFrame: From baseline to five years after surgery
Secondary outcomes:
measure: Remission or improvement of Type 2 Diabetes Mellitus
timeFrame: From baseline to five years after surgery
measure: Remission or improvement of Hypertension
timeFrame: From baseline to five years after surgery
measure: Remission of improvement of Dyslipidemia
timeFrame: From baseline to five years after surgery
measure: Remission or improvement of Obstructive Sleep Apnea Syndrome
timeFrame: From baseline to five years after surgery
Other outcomes:
measure: Quality of life after surgery
timeFrame: From baseline to five years after surgery
Locations:
city: Denia
country: Spain
facility: Juan José Arroyo Martín
state: Alicante
city: Mataró
country: Spain
facility: Esther Mans Muntwyler
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Débora Acín Gándara
state: Madrid
Study officials:
References: