Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2021-12-02
Brief Title:
Small Bowel Diversion
Sponsor:
University of Ostrava
Organization:
University of Ostrava
Study Overview
Official Title:
Jejuno-ileal and Jejuno-colic Diversion as a New Bariatric Method in Treatment Diabetes and Obesity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In an effort to replicate metabolic surgerys durable results in metabolic disease while minimizing its risks two innovative methods has been created Two surgical methods to create a bowel-to-bowel anastomosis similar to the type used in current metabolic surgeries It be to create a jejuno-ileal side-to-side anastomosis and jejunocolic side-to-side anastomosis The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food The new shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass RYGB and biliopancreatic diversion BPD - procedures which leads to weight loss Additionally delivery of non-absorbed macronutrients to the distal ileum or transverse colon can enhance incretin effect and improve Type 2 Diabetes Mellitus parameters However the native route is also preserved which theoretically reduces the risk of malnutrition diarrhea and metabolic derangements seen in other metabolic surgeriesThe side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic SFM Anastomosis Device for Creation of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 15 The results of this study demonstrated the safety of this approach without serious adverse events This non-surgical approach resulted in significant weight loss favorable changes in insulin and incretin responses to a mixed meal and significant improvement in HbA1c in T2DM 16In summary metabolic diseases are a growing pandemic with suboptimal clinical solutions The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks
Detailed Description:
The study subjects who meet Inclusion criteria and baseline procedures undergo surgery jejunal-ileal diversion jejuno-colic diversion The surgery is performed in general anesthesia with orotracheal intubation The laparoscopic approach is used After establishing pneumoperitoneum insufluation of the abdominal cavity with CO2 the 1th trocar and laparoscopic camera are introduced through small incision After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced The site of future anastomosis is identified 45 cm from ligament of Treitz on jejunum and 45 cm for the ileocoecal junction on ileum The anastomosis between these two parts of jejunum and ileum is created by the means of linear stapler 45 mm The residual defect is closed by manual continuous suture The food will be passed through intestine partially through whole small intestine and partially through the anastomosis In the second group of patients is the anastomosis created between jejunum 45 from ligament of Treitz and transverse colon behind the liver flexure by means of the same technique Before the end of the operation the control of bleeding is performed Afterwards the trocars are removed under visual control The pneumoperitoneum is released and the incisions are sutured The subject will have follow-up clinic visits specific to the study at weeks 1 2 and 3 and at months 1 2 3 6 12 18 24 30 and 36 after the original procedure At each clinic visit the subject will undergo review of medical history assessment for adverse events physical examination including weight and girth measurements and blood work eg glycated hemoglobin HbA1c At specific intervals principal metabolic studies will be performed including a mixed meal tolerance test Upper GI series radiographic studies at baseline and 14days after procedure as well as at the discretion of the principal investigator will be performed focusing on the patency of the anastomosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None