Small Bowel Diversion

August 13, 2025 updated by: University of Ostrava

Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial

In an effort to replicate metabolic surgery's 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 surgeries.The 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 (16).In 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 (e.g. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czechia
      • Ostrava, Czechia, 70300
        • Recruiting
        • University of Ostrava
        • Contact:
        • Principal Investigator:
          • Marek Bužga
      • Ostrava, Czechia
        • Completed
        • University of Ostrava, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-65 years at screening;
  • Body mass index ≥30 or ≤50kg/m2;
  • If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication;
  • If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.

Exclusion Criteria:

  • Body Mass Index >50 or <30 kg/m2;
  • Diagnosis of Type 2 diabetes less than 6 months;
  • History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);
  • History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;
  • Ongoing systemic infection;
  • Chronic pancreatitis;
  • Chronic liver disease of any cause;
  • Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis);
  • Any history of an eating disorder within the past 5 years;
  • Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism);
  • uncontrolled hypertension (systolic Blood Preassure > 150 mm Hg or diastolic Blood Preassure > 100 mm Hg).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: obese patients with jejuno-ileal diversion
Jejuno-ileal diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing.
Procedure: jejuno-ileal 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).
Active Comparator: obese patients with jejuno-colic diversion
Jejuno-colic diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing
Procedure: 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 anastomosis is created between jejunum (45 from ligament of Treitz) and transverse colon (behind the liver flexure).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total body weight loss
Time Frame: 36 months
Weight change in percentage
36 months
Glycated hemoglobin loss
Time Frame: 36 months
Glycated hemoglobin change in blood
36 months
Diabetes medication loss
Time Frame: 36 months
Reduction in diabetes medication requirements (for diabetic cohort) - absolute value
36 months
Total cholesterol loss
Time Frame: 36 months
Total cholesterol loss in blood
36 months
Low density lipoprotein loss
Time Frame: 36 months
Low density lipoprotein loss in blood
36 months
High density lipoprotein loss
Time Frame: 36 months
High density lipoprotein loss in blood
36 months
Leptin metabolism evaluation
Time Frame: 36 months
Leptin value increase/decrease in blood
36 months
Adiponectin metabolism evaluation
Time Frame: 36 months
Adiponectin value increase/decrease in blood
36 months
Bile acids metabolism evaluation
Time Frame: 36 months
Bile acids value increase/decrease in blood
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline quality of life-Lite
Time Frame: 36 months
Questionary "Weight on Quality of Life-Lite (IWQOL-Lite)"
36 months
Change from baseline quality of life - Sort Form Survey
Time Frame: 36 months
Questionary "36-Item Short Form Survey (SF-36)"
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ostrava

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute for Clinical and Experimental Medicine
Vitkovice Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marek Bužga, Doc., University of Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JID-SURG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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