Sleeve Gastrectomy With Jejunoileal AnastomosisNCT03939442
Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity
An observational study of Sleeve Gastrectomy With Jejunoileal Anastomosis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleeve Gastrectomy With Jejunoileal Anastomosis
- What is being tested?
- Sleeve gastrectomy with jejunoileal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2019to 3 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients aged between 18 and 60 years with a body mass index greater than 40, no comorbidity or a body mass index of 35-40, with a comorbidity (diabetes mellitus, hypertension, obstructive sleep apnea)
Inclusion Criteria:All patients who underwent the sleeve gastrectomy with jejunoileal bypass between 2015-2018 for the treatment morbid obesity
Exclusion Criteria:other operations for morbid obesity except sleeve gastrectomy with jejunoileal bypass
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.
Read the detailed description
Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.
Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.
- Being tested
- Sleeve gastrectomy with jejunoileal anastomosis
- Keywords
- obesity, diabetes mellitus, bariatric surgery
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy with jejunoileal anastomosisProcedure or surgery
The sleeve gastrectomy was performed first, after using a sealer and divider device to dissect the omentum away from the greater gastric curvature from approximately 5 cm proximal to the pylorus up to the angle of His. Excision of the fundus and the body of the stomach was then performed with a laparoscopic linear stapler upon a 36 French orogastric tube (bougie). An isoperistaltic side-to-side anastomosis between the jejunum (at 50 cm distal to the Treitz ligament) and the distal ileum ( at 200 cm proximal to the ileocecal valve) was then created using the same linear stapler with a blue cartridge (3.5 mm). A soft Penrose drain was left at the subdiaphragmatic space, and the abdominal wound was closed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss
body mass index (BMI) 25 was considered ideal. The ratio of the value above this value to the value that arrived at the end of 2 years was calculated. Over 80% was considered successful.
Measured: 2 years
diabetes remission
- Complete remission absence antidiabetic medications, HbA1c level below 6%, fasting blood glucose value below 100 mg / dl
- partial remission Subdiabetic hyperglycemia (HbA1c 6%-6.4%, FBG 100-125 mg/dL) in the absence antidiabetic medications
- Unchanged The absence of remission or improvement as described earlier
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start10 Feb 2019
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeve Gastrectomy With Jejunoileal AnastomosisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cihan gokler, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939442
- Sponsor's protocol ID
- 2019/3-10
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity
- ClinicalTrials.gov ID
- NCT03939442
- Acronym / sponsor ID
- 2019/3-10
- Keywords
- obesity, diabetes mellitus, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.
Detailed description
Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.
Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients aged between 18 and 60 years with a body mass index greater than 40, no comorbidity or a body mass index of 35-40, with a comorbidity (diabetes mellitus, hypertension, obstructive sleep apnea)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomy with jejunoileal anastomosisThe sleeve gastrectomy was performed first, after using a sealer and divider device to dissect the omentum away from the greater gastric curvature from approximately 5 cm proximal to the pylorus up to the angle of His. Excision of the fundus and the body of the stomach was then performed with a laparoscopic linear stapler upon a 36 French orogastric tube (bougie). An isoperistaltic side-to-side anastomosis between the jejunum (at 50 cm distal to the Treitz ligament) and the distal ileum ( at 200 cm proximal to the ileocecal valve) was then created using the same linear stapler with a blue cartridge (3.5 mm). A soft Penrose drain was left at the subdiaphragmatic space, and the abdominal wound was closed. | Procedure or surgery | – |
Primary outcome
Excess weight loss
Time frame: 2 years
body mass index (BMI) 25 was considered ideal. The ratio of the value above this value to the value that arrived at the end of 2 years was calculated. Over 80% was considered successful.
diabetes remission
Time frame: 2 years
1. Complete remission absence antidiabetic medications, HbA1c level below 6%, fasting blood glucose value below 100 mg / dl 2. partial remission Subdiabetic hyperglycemia (HbA1c 6%-6.4%, FBG 100-125 mg/dL) in the absence antidiabetic medications 3. Unchanged The absence of remission or improvement as described earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleeve Gastrectomy With Jejunoileal Anastomosis, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.