Bariatric Surgery CandidateNCT04109664
The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Jul 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent Laparoscopic Sleeve Gastrectomy between January 2016 and June 2018 are retrospectively analyzed.
Who may be able to join
- Patients with Body Mass Index > 40 were included
Who cannot join
- Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Training and research Hospital
Kocasinan, Derince, 41900
About this study
Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. The investigator's retrospective cohort study aimed to determine whether AR is superior to antral preservation (AP) regarding weight loss and resolution of co-morbidities.
Methods: Patients were divided into two groups according to the distance of gastric division as AR group (2cm from pylorus) and AP group (6cm from pylorus). Postoperative excess weight loss percentile (%EWL) and total body weight loss percentiles (%TBWL) at the end of first, 6th and 12 months were compared. Secondly, metabolic parameters and complications were compared.
Read the detailed description
Following approval of the ethical committee patients who underwent LSG between January 2016 and June 2018 are retrospectively analyzed. Patients with BMI > 40 were included. Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded.
The patients were grouped according to the distance of gastric division as AP group (6cm from pylorus) and AR group (2cm prom pylorus). The first 68 patients underwent AP, and the following 43 patients underwent AR.
Patient characteristics and demographic data, including age, gender, BMI, co-morbid diseases (hypertension (HT), Type II diabetes, dyslipidemia), biochemical parameters (glucose, HbA1c, C-peptide, insulin, , cholesterol, triglyceride, HDL, LDL, and VLDL was extracted from a prospectively prepared patient's chart. The 30-day outcomes including postoperative morbidity and mortality are taken from patient's folder.
Weight loss alteration at the end of first, 6th and 12 months are calculated as %EWL and %TBWL. The %EWL is calculated as [(preoperative weight - follow up weight) / (preoperative weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2. The total body weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up weight) / (preoperative body weight)] x100.
Resolution of co-morbidities was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges.
The Clavien-Dindo classification scale was used to define the severity of complications: Grade I; no requirement of specific intervention, Grade II; antibiotic treatment, total parenteral nutrition, and/or blood transfusion is mandatory, Grade III; invasive interventions such as endoscopy, percutaneous drainage, or surgery is needed, Grade IV; intensive care management for organ dysfunction, and Grade V; as death, respectively [10].
2.1. Surgical Technique The LSGs were performed by two surgeons. Patients were placed in supine position. Antibiotic prophylaxis was started before anesthesia induction by using 2g first-generation cephalosporin for patients <120kg, and 3g for patients ≥120 kg. The liver is retracted by using Nathanson Hook. The greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line. The gastric specimen is removed through the 12mm trocar. The procedure is completed by placing an abdominal drain just next to the staple line.
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid
- Being tested
- laparoscopic sleeve gastrectomy
- Keywords
- antral resection, sleeve gastrectomy, excess weight loss, total body weight loss
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
The greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line.
| Study group | Role | What they receive |
|---|---|---|
| antral preservation | The patients were grouped according to the distance of gastric division as Antral preservation group (6cm from pylorus) Receives: Procedure: laparoscopic sleeve gastrectomy | |
| Antral resection | The patients were grouped according to the distance of gastric division as Antral preservation group (2 cm from pylorus) Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose(mg/dl) change
Preoperative fasting glucose (mg/dl) values compared with fasting glucose (mg/dl) values at 12 months.
Measured: 0, 12. month
Glycated hemoglobin(Hb A1c) (mmol/mol) change
Preoperative glycated hemoglobin(Hb A1c) (mmol/mol) values compared with glycated hemoglobin(Hb A1c) (mmol/mol) values at 12 months.
Measured: 0, 12. month
C-Peptide(ng/ml) change
Preoperative C-peptide (ngl/ml) values compared with C-peptide (ngl/ml) values at 12 months.
Measured: 0, 12. month
Insulin (mg/dl) change
Preoperative Insulin (mg/dl) values compared with Insulin (mg/dl) values at 12 months.
Measured: 0, 12. month
Cholesterol (mg/dl) levels change
Preoperative Cholesterol (mg/dl) values compared with Cholesterol (mg/dl) values at 12 months.
Measured: 0, 12. month
Triglyceride(mg/dl) levels change
Preoperative Triglyceride(mg/dl) values compared with Triglyceride(mg/dl) values at 12 months.
Measured: 0, 12. month
HDL (mg/dl) levels change
Preoperative HDL(mg/dl) values compared with HDL(mg/dl) values at 12 months.
Measured: 0, 12. month
LDL (mg/dl) levels change
Preoperative LDL(mg/dl) values compared with LDL(mg/dl) values at 12 months.
Measured: 0, 12. month
VLDL (mg/dl) levels change
Preoperative VLDL(mg/dl) values compared with VLDL(mg/dl) values at 12 months.
Measured: 0, 12. month
Resolution of co-morbidities
Resolution of co-morbidities (hypertension, hyperlipidemia, diabetes type 2) was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges. Preoperative status will be compared with 12.months status.
Measured: 0,12. month
Excess Weight Loss change
The %Excess Weight Loss is calculated as [(preoperative weight - follow up(1,6,12 month weight) / (preoperative weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2.
Measured: 0,1,6, 12. month
The total body weight loss percentile change
The total body weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up(1,6,12. month weight) / (preoperative body weight)] x100. ideal weight based on a BMI of 25kg/m2
Measured: 0,1,6, 12. month
Secondary outcomes (1)
complication
The Clavien-Dindo classification scale was used to define the severity of complications: Grade I; no requirement of specific intervention, Grade II; antibiotic treatment, total parenteral nutrition, and/or blood transfusion is mandatory, Grade III; invasive interventions such as endoscopy, percutaneous drainage, or surgery is needed, Grade IV; intensive care management for organ dysfunction, and Grade V; as death, respectively
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startJan 2016
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Yuksel, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109664
- Sponsor's protocol ID
- 2019-69
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04109664
- Acronym / sponsor ID
- 2019-69
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid
- Keywords
- antral resection, sleeve gastrectomy, excess weight loss, total body weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 30 Sep 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.
Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. The investigator's retrospective cohort study aimed to determine whether AR is superior to antral preservation (AP) regarding weight loss and resolution of co-morbidities.
Methods: Patients were divided into two groups according to the distance of gastric division as AR group (2cm from pylorus) and AP group (6cm from pylorus). Postoperative excess weight loss percentile (%EWL) and total body weight loss percentiles (%TBWL) at the end of first, 6th and 12 months were compared. Secondly, metabolic parameters and complications were compared.
Detailed description
Following approval of the ethical committee patients who underwent LSG between January 2016 and June 2018 are retrospectively analyzed. Patients with BMI > 40 were included. Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded.
The patients were grouped according to the distance of gastric division as AP group (6cm from pylorus) and AR group (2cm prom pylorus). The first 68 patients underwent AP, and the following 43 patients underwent AR.
Patient characteristics and demographic data, including age, gender, BMI, co-morbid diseases (hypertension (HT), Type II diabetes, dyslipidemia), biochemical parameters (glucose, HbA1c, C-peptide, insulin, , cholesterol, triglyceride, HDL, LDL, and VLDL was extracted from a prospectively prepared patient's chart. The 30-day outcomes including postoperative morbidity and mortality are taken from patient's folder.
Weight loss alteration at the end of first, 6th and 12 months are calculated as %EWL and %TBWL. The %EWL is calculated as [(preoperative weight - follow up weight) / (preoperative weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2. The total body weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up weight) / (preoperative body weight)] x100.
Resolution of co-morbidities was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges.
The Clavien-Dindo classification scale was used to define the severity of complications: Grade I; no requirement of specific intervention, Grade II; antibiotic treatment, total parenteral nutrition, and/or blood transfusion is mandatory, Grade III; invasive interventions such as endoscopy, percutaneous drainage, or surgery is needed, Grade IV; intensive care management for organ dysfunction, and Grade V; as death, respectively [10].
2.1. Surgical Technique The LSGs were performed by two surgeons. Patients were placed in supine position. Antibiotic prophylaxis was started before anesthesia induction by using 2g first-generation cephalosporin for patients <120kg, and 3g for patients ≥120 kg. The liver is retracted by using Nathanson Hook. The greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line. The gastric specimen is removed through the 12mm trocar. The procedure is completed by placing an abdominal drain just next to the staple line.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antral preservation | – | Procedure: laparoscopic sleeve gastrectomyThe patients were grouped according to the distance of gastric division as Antral preservation group (6cm from pylorus) |
| Antral resection | – | Procedure: laparoscopic sleeve gastrectomyThe patients were grouped according to the distance of gastric division as Antral preservation group (2 cm from pylorus) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent Laparoscopic Sleeve Gastrectomy between January 2016 and June 2018 are retrospectively analyzed.
Key inclusion criteria (1 listed)
- Patients with Body Mass Index > 40 were included
Key exclusion criteria (1 listed)
- Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded
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 sleeve gastrectomyThe greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line. | Procedure or surgery | Antral resection, antral preservation |
Primary outcome
Glucose(mg/dl) change
Time frame: 0, 12. month
Preoperative fasting glucose (mg/dl) values compared with fasting glucose (mg/dl) values at 12 months.
Glycated hemoglobin(Hb A1c) (mmol/mol) change
Time frame: 0, 12. month
Preoperative glycated hemoglobin(Hb A1c) (mmol/mol) values compared with glycated hemoglobin(Hb A1c) (mmol/mol) values at 12 months.
C-Peptide(ng/ml) change
Time frame: 0, 12. month
Preoperative C-peptide (ngl/ml) values compared with C-peptide (ngl/ml) values at 12 months.
Insulin (mg/dl) change
Time frame: 0, 12. month
Preoperative Insulin (mg/dl) values compared with Insulin (mg/dl) values at 12 months.
Cholesterol (mg/dl) levels change
Time frame: 0, 12. month
Preoperative Cholesterol (mg/dl) values compared with Cholesterol (mg/dl) values at 12 months.
Triglyceride(mg/dl) levels change
Time frame: 0, 12. month
Preoperative Triglyceride(mg/dl) values compared with Triglyceride(mg/dl) values at 12 months.
HDL (mg/dl) levels change
Time frame: 0, 12. month
Preoperative HDL(mg/dl) values compared with HDL(mg/dl) values at 12 months.
LDL (mg/dl) levels change
Time frame: 0, 12. month
Preoperative LDL(mg/dl) values compared with LDL(mg/dl) values at 12 months.
VLDL (mg/dl) levels change
Time frame: 0, 12. month
Preoperative VLDL(mg/dl) values compared with VLDL(mg/dl) values at 12 months.
Resolution of co-morbidities
Time frame: 0,12. month
Resolution of co-morbidities (hypertension, hyperlipidemia, diabetes type 2) was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges. Preoperative status will be compared with 12.months status.
Excess Weight Loss change
Time frame: 0,1,6, 12. month
The %Excess Weight Loss is calculated as [(preoperative weight - follow up(1,6,12 month weight) / (preoperative weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2.
The total body weight loss percentile change
Time frame: 0,1,6, 12. month
The total body weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up(1,6,12. month weight) / (preoperative body weight)] x100. ideal weight based on a BMI of 25kg/m2
1 secondary outcome
complication
Time frame: 1 year
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 30 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Bariatric Surgery Candidate and Obesity, Morbid, run by Kocaeli Derince Education and Research Hospital 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?
The sponsor lists 1 inclusion and 1 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 30 Sep 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?
Glucose(mg/dl) change (time frame: 0, 12. month). The study lists 12 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 30 Sep 2019.