Bariatric Surgery CandidateNCT04323072
Does Antrum Size Matter in Sleeve Gastrectomy?
A study testing Wide antrectomy and Smal antrectomy in people with Bariatric Surgery Candidate, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial summary
Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Wide antrectomy and Smal antrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2015to 1 Jan 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent.
- morbid obesity defined as body mass index (BMI) 40 kg/m2
Who cannot join
- previous bariatric surgical procedures,
- endocrine disorders causing obesity
- pregnancy or lactation
- psychiatric illness
- inflammatory bowel disease
- Barrett ́s oesophagus
Show all 9Show fewer
- severe GERD with esophagitis B and C
- a large hiatal hernia (>5 cm)
- GERD-HRQLscore > 25 dietary restriction despite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery
Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11[6]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Wide antrectomy, Smal antrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide antrectomyProcedure or surgery
The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.
Smal antrectomyProcedure or surgery
The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Resection of antrum proximally 2 cm to the pylorus Receives: Procedure: Wide antrectomy |
| Group B | Active comparator | Resection of antrum proximally 6 cm to the pylorus Receives: Procedure: Smal antrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative weight and height combined to report BMI in kg/m^2
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Measured: 3 months
Postoperative weight and height combined to report BMI in kg/m^2
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Measured: 6 months
Postoperative weight and height combined to report BMI in kg/m^2
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Measured: 12 months
Postoperative weight and height combined to report BMI in kg/m^2
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Measured: 24 months
Postoperative percentage excess weigth loss
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Measured: 3 months
Postoperative percentage excess weigth loss
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Measured: 6 months
Postoperative percentage excess weigth loss
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Measured: 12 months
Postoperative percentage excess weigth loss
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Measured: 24 months
Secondary outcomes (6)
Gastroesophageal reflux disease(GERD)
Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference
Measured: at 12 months
Gastroesophageal reflux disease(GERD)
Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference
Measured: at 24 months
Gastroesophageal reflux disease symptoms
All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.
Patients with GERD-HRQL score >16 was considered positive for GERD.
Measured: at 3 months
Gastroesophageal reflux disease symptoms
All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.
Patients with GERD-HRQL score >16 was considered positive for GERD.
Measured: at 6 months
Gastroesophageal reflux disease symptoms
All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.
Patients with GERD-HRQL score >16 was considered positive for GERD.
Measured: at 12 months
Gastroesophageal reflux disease symptoms
All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50.
Patients with GERD-HRQL score >16 was considered positive for GERD.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Mar 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323072
- Sponsor's protocol ID
- 01032020
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04323072
- Acronym / sponsor ID
- 01032020
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 26 Mar 2020 (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 (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11[6]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Wide antrectomyResection of antrum proximally 2 cm to the pylorus |
| Group B | Active comparator | Procedure: Smal antrectomyResection of antrum proximally 6 cm to the pylorus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- informed consent.
- morbid obesity defined as body mass index (BMI) 40 kg/m2
Key exclusion criteria (9 listed)
- previous bariatric surgical procedures,
- endocrine disorders causing obesity
- pregnancy or lactation
- psychiatric illness
- inflammatory bowel disease
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 |
|---|---|---|
| Wide antrectomyThe starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm. | Procedure or surgery | Group A |
| Smal antrectomyThe starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm. | Procedure or surgery | Group B |
Primary outcome
Postoperative weight and height combined to report BMI in kg/m^2
Time frame: 3 months
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Postoperative weight and height combined to report BMI in kg/m^2
Time frame: 6 months
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Postoperative weight and height combined to report BMI in kg/m^2
Time frame: 12 months
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Postoperative weight and height combined to report BMI in kg/m^2
Time frame: 24 months
Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)
Postoperative percentage excess weigth loss
Time frame: 3 months
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Postoperative percentage excess weigth loss
Time frame: 6 months
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Postoperative percentage excess weigth loss
Time frame: 12 months
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
Postoperative percentage excess weigth loss
Time frame: 24 months
Change of weight expressed in percentage of excess weight loss postoperatively at follow-up
6 secondary outcomes
Gastroesophageal reflux disease(GERD)
Time frame: at 12 months
Gastroesophageal reflux disease(GERD)
Time frame: at 24 months
Gastroesophageal reflux disease symptoms
Time frame: at 3 months
Gastroesophageal reflux disease symptoms
Time frame: at 6 months
Gastroesophageal reflux disease symptoms
Time frame: at 12 months
Gastroesophageal reflux disease symptoms
Time frame: at 24 months
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 26 Mar 2020.
- Individual participant dataSharing planned: No
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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?
A study testing Wide antrectomy and Smal antrectomy in people with Bariatric Surgery Candidate, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
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 9 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 26 Mar 2020. 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 Italy. 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?
Postoperative weight and height combined to report BMI in kg/m^2 (time frame: 3 months). The study lists 8 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 26 Mar 2020.