Bariatric SurgeryNCT03983135
Revisional Bariatric Surgery Experience
A study testing Laparoscopic mini gastric by-pass, LaparoscopicRe-sleeve gastrectomy and Laparoscopic Roux-en-Ygastric bypass in people with Bariatric Surgery and Revisional Bariatric Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Trial summary
The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Revisional Bariatric Surgery, Obesity Associated Disorder
- What is being tested?
- Laparoscopic mini gastric by-pass, LaparoscopicRe-sleeve gastrectomy and Laparoscopic Roux-en-Ygastric bypass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 1 Dec 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 to 65 years old,
- Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery
Who cannot join
- Eating disorders,
- Alcoholic
- Cancer
About this study
Official title: Results of Revisional Bariatric Surgery: A Single Center Experience
The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.
- Being tested
- Laparoscopic mini gastric by-pass, LaparoscopicRe-sleeve gastrectomy, Laparoscopic Roux-en-Ygastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic mini gastric by-passOther
Adhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches.
LaparoscopicRe-sleeve gastrectomyOther
Adhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie.
Laparoscopic Roux-en-Ygastric bypassOther
all adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients who undergo revisional bariatric surgery Receives: Other: Laparoscopic mini gastric by-pass; Other: LaparoscopicRe-sleeve gastrectomy; Other: Laparoscopic Roux-en-Ygastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (kilograms)
Amount of weight loss (kilograms) before (Day of surgery) and after (At three years) revisional bariatric surgery
Measured: 3 years
Secondary outcomes (1)
Resolution of comorbidities
The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about "did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes?"comorbidities at the end of follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Mar 2012
- Primary completion1 Jun 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hakan Seyit, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983135
- Sponsor's protocol ID
- BakırkoySadiKGeneralSurgery
- Status last verified
- Jun 2019
- First submitted
- 26 May 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Revisional Bariatric Surgery: A Single Center Experience
- ClinicalTrials.gov ID
- NCT03983135
- Acronym / sponsor ID
- BakırkoySadiKGeneralSurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 12 Jun 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.
The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Laparoscopic mini gastric by-pass, Other: LaparoscopicRe-sleeve gastrectomy, Other: Laparoscopic Roux-en-Ygastric bypassPatients who undergo revisional bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 to 65 years old,
- Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery
Key exclusion criteria (3 listed)
- Eating disorders,
- Alcoholic
- Cancer
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 |
|---|---|---|
| Laparoscopic mini gastric by-passAdhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches. | Other | Study group |
| LaparoscopicRe-sleeve gastrectomyAdhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie. | Other | Study group |
| Laparoscopic Roux-en-Ygastric bypassall adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall. | Other | Study group |
Primary outcome
Weight loss (kilograms)
Time frame: 3 years
Amount of weight loss (kilograms) before (Day of surgery) and after (At three years) revisional bariatric surgery
1 secondary outcome
Resolution of comorbidities
Time frame: 3 years
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 12 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic mini gastric by-pass, LaparoscopicRe-sleeve gastrectomy and Laparoscopic Roux-en-Ygastric bypass in people with Bariatric Surgery and Revisional Bariatric Surgery, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight loss (kilograms) (time frame: 3 years). 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 12 Jun 2019.