Laparoscopic Sleeve GastrectomyNCT03629808
Laparoscopic Sleeve Gastrectomy: a Cohort Study
An observational study of Laparoscopic Sleeve Gastrectomy, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a prospective cohort study, which subjects were obese patients requiring LSG surgery. LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as intervention method. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy
- What is being tested?
- 4-6cm from starting point of gastrectomy to pylorus and 2-4cm from starting point of gastrectomy to pylorus
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2018to 20 Apr 2020
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
Who may be able to join
- Patients were accepted for surgery if they satisfied the guidelines of the Society of Chinese Gastroenterological Surgeons [body mass index (BMI) ≥40 kg/m2 or BMI ≥35 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea), age between 18 and 60 years, and failure of conservative treatment over 2 years].
- All patients undergo preoperative upper gastrointestinal (GI) endoscopy.
Who cannot join
- any patient who had previously been submitted to any type of bariatric surgery;
- patient currently taking anti-nausea or GERD medications preoperatively;
- any current smokers；
- active duodenal/gastric ulcer disease；
- difficult to treat gastroesophageal reflux disease (GERD) with a large hiatal hernia；
- previous major gastrointestinal surgery；
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- diagnosed or suspected malignancy；
- poorly controlled significant medical or psychiatric disorders；
- disorders such as a medical history of major pathology;
- can not be able to understand and willing to participate in this registry with signature.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Residual Gastric Antrum Size During Laparoscopic Sleeve Gastrectomy in Reducing Postoperative Gastrointestinal Symptoms: a Cohort Study
This is a prospective cohort study, which subjects were obese patients requiring LSG surgery. LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as intervention method. The main observation is the incidence and extent of upper gastrointestinal symptoms (such as nausea, vomiting, retching, reflux, difficulty swallowing, etc.).In addition, secondary observations include the excess weight loss (%EWL) and postoperative complications. Aim to investigate the effects of LSG surgery in different starting points of gastric resection on postoperative upper gastrointestinal symptoms.
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Being tested
- 4-6cm from starting point of gastrectomy to pylorus, 2-4cm from starting point of gastrectomy to pylorus
- Keywords
- metabolic surgery, laparoscopic sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-6cm from starting point of gastrectomy to pylorusProcedure or surgery
The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.
2-4cm from starting point of gastrectomy to pylorusProcedure or surgery
The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.
| Study group | Role | What they receive |
|---|---|---|
| Group1: 4-6cm | 4-6cm from starting point of gastrectomy to pylorus Receives: Procedure: 4-6cm from starting point of gastrectomy to pylorus | |
| Group2: 2-4cm | 2-4cm from starting point of gastrectomy to pylorus Receives: Procedure: 2-4cm from starting point of gastrectomy to pylorus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of upper gastrointestinal symptoms after surgery
We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales describe postoperative upper gastrointestinal symptoms,which include vomiting, dysphagia,and acid reflux,heartburn.We focus on the incidence rate of the above symptoms in one year after surgery during 1 year.
Visit: Post-op 12 months Visit(±7 Days)
Measured: 1 year after surgery
Secondary outcomes (3)
The excess weight loss (%EWL) after surgery
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2).
Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 days Visit Visit 3: Post-op 7 days Visit Visit 4: Post-op 1 month Visit(±3 Days) Visit 5: Post-op 3 months Visit(±7 Days) Visit 6: Post-op 12 months Visit(±7 Days)
Measured: 1 year after surgery
the rate of postoperative complications after surgery
Postoperative complications including but not limited to: 1, abdominal bleeding; 2, gastrointestinal bleeding; 3, intestinal obstruction; 4, digestive tract leakage 5, anastomotic stenosis / gastric stenosis; 6, death ,etc.
Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 days Visit Visit 3: Post-op 7 days Visit Visit 4: Post-op 1 month Visit(±3 Days) Visit 5: Post-op 3 months Visit(±7 Days) Visit 6: Post-op 12 months Visit(±7 Days)
Measured: 1 year after surgery
The extent of upper gastrointestinal symptoms after surgery
We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales quantify the degree of vomiting, difficulty swallowing, acid reflux, heartburn, etc.We will calculate the extent of the above upper gastrointestinal symptoms at five time points in one year after surgery.
Visit 1: Post-op 3 days Visit Visit 2: Post-op 7 days Visit Visit 3: Post-op 1 month Visit(±3 Days) Visit 4: Post-op 3 months Visit(±7 Days) Visit 5: Post-op 12 months Visit(±7 Days)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Jul 2018
- Primary completion28 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Sleeve GastrectomyStudies 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
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Tiantan Hospital, Beijing Hospital, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629808
- Sponsor's protocol ID
- BFH-LSG 01
- Status last verified
- Apr 2020
- First submitted
- 17 Jul 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Residual Gastric Antrum Size During Laparoscopic Sleeve Gastrectomy in Reducing Postoperative Gastrointestinal Symptoms: a Cohort Study
- ClinicalTrials.gov ID
- NCT03629808
- Acronym / sponsor ID
- BFH-LSG 01
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Keywords
- metabolic surgery, laparoscopic sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Tiantan Hospital, Beijing Hospital, Beijing Shijitan Hospital, Capital Medical University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 14 Aug 2018 (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.
This is a prospective cohort study, which subjects were obese patients requiring LSG surgery. LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as intervention method. The main observation is the incidence and extent of upper gastrointestinal symptoms (such as nausea, vomiting, retching, reflux, difficulty swallowing, etc.).In addition, secondary observations include the excess weight loss (%EWL) and postoperative complications. Aim to investigate the effects of LSG surgery in different starting points of gastric resection on postoperative upper gastrointestinal symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: 4-6cm | – | Procedure: 4-6cm from starting point of gastrectomy to pylorus4-6cm from starting point of gastrectomy to pylorus |
| Group2: 2-4cm | – | Procedure: 2-4cm from starting point of gastrectomy to pylorus2-4cm from starting point of gastrectomy to pylorus |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
Key inclusion criteria (2 listed)
- Patients were accepted for surgery if they satisfied the guidelines of the Society of Chinese Gastroenterological Surgeons [body mass index (BMI) ≥40 kg/m2 or BMI ≥35 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea), age between 18 and 60 years, and failure of conservative treatment over 2 years].
- All patients undergo preoperative upper gastrointestinal (GI) endoscopy.
Key exclusion criteria (10 listed)
- any patient who had previously been submitted to any type of bariatric surgery;
- patient currently taking anti-nausea or GERD medications preoperatively;
- any current smokers；
- active duodenal/gastric ulcer disease；
- difficult to treat gastroesophageal reflux disease (GERD) with a large hiatal hernia；
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 |
|---|---|---|
| 4-6cm from starting point of gastrectomy to pylorusThe starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative. | Procedure or surgery | Group1: 4-6cm |
| 2-4cm from starting point of gastrectomy to pylorusThe starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative. | Procedure or surgery | Group2: 2-4cm |
Primary outcome
The incidence rate of upper gastrointestinal symptoms after surgery
Time frame: 1 year after surgery
We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales describe postoperative upper gastrointestinal symptoms,which include vomiting, dysphagia,and acid reflux,heartburn.We focus on the incidence rate of the above symptoms in one year after surgery during 1 year. Visit: Post-op 12 months Visit(±7 Days)
3 secondary outcomes
The excess weight loss (%EWL) after surgery
Time frame: 1 year after surgery
the rate of postoperative complications after surgery
Time frame: 1 year after surgery
The extent of upper gastrointestinal symptoms after surgery
Time frame: 1 year after surgery
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 22 Apr 2020.
- Results publicationChow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.
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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.
Zhongtao Zhang principal investigator
Beijing Friendship Hospital
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 Laparoscopic Sleeve Gastrectomy, run by Beijing Friendship Hospital at 1 site in China.
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 10 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 22 Apr 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 China. 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?
The incidence rate of upper gastrointestinal symptoms after surgery (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629808, which also lists 1 linked publication.
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 22 Apr 2020.