Bariatric Surgery CandidateNCT04644445
Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
A study testing Bariatric Full Liquid Diet in people with Bariatric Surgery Candidate and Postoperative Nausea and Vomiting, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Postoperative Nausea and Vomiting, Morbid Obesity
- What is being tested?
- Bariatric Full Liquid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2020to 31 Oct 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient undergoing robotic or laparoscopic sleeve gastrectomy
- Patient able to provide written informed consent
- Patient able to understand and comply with study guidelines
Who cannot join
- Inability to provide consent
- Previous history of bariatric or gastroesophageal surgery
- Chronic nausea/vomiting
- Hemoglobin A1C 9 or higher
- Therapeutic anticoagulation
- Celiac disease or gluten sensitivity/intolerance/allergy
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Talar Tatarian, MD, talar.tatarian@jefferson.edu
Talar Tatarian, MD
- Recruiting
Jefferson Methodist Hospital
Philadelphia, Pennsylvania, 19148
Talar Tatarian, MD, talar.tatarian@jefferson.edu
Talar Tatarian, MD
About this study
Official title: Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting
Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. This study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.
Read the detailed description
Patients with obesity or morbid obesity who are scheduled to undergoing robotic or laparoscopic sleeve gastrectomy will be screened at their preoperative visit. If they meet inclusion/exclusion criteria, they will be invited to participate in the study and written informed consent will be obtained. If the patient consents to participation, they will be randomized to either the control arm or intervention arm. All patients will undergo sleeve gastrectomy in a standard fashion, either laparoscopically or robotically, as discussed with their bariatric surgeon. Post-operative diet will be initiated 4 hours after surgery. The specific diet received will depend on which arm the patient is randomized into. Post-operative assessments will be completed at various time points for all patients. These include a Verbal Rating Scale of Nausea and Vomiting, Rhodes Index Survey, and Quality of Recover-15 Survey. All patients will track their oral intake on a spreadsheet which will be provided. Additional demographic and clinical data will be collected from the Electronic Medical Record. After hospital discharge, patients will follow up in the clinic one week and one month after surgery, per routine. After the one-month visit, the patient's study participation will be considered complete.
- Being tested
- Bariatric Full Liquid Diet
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Full Liquid DietDietary supplement
Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard bariatric clear liquid diet to be started 4 hours after surgery |
| Intervention | Experimental | Bariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery Receives: Dietary Supplement: Bariatric Full Liquid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting related delay in hospital discharge
Inability to be discharged from the hospital on postoperative day 1 due to postoperative nausea and vomiting. This will be measured by inability to maintain oral intake of 4-6 ounces an hour due to feeling of nausea or vomiting.
Measured: through hospital discharge, an average of two days after surgery
Secondary outcomes (7)
Length of Stay
Time from end of surgery to discharge from hospital
Measured: through hospital discharge, an average of two days after surgery
Severity of Postoperative Nausea and Vomiting
Patient reported severity based on surveys
Measured: Baseline until 1 month after surgery
Patient Self-Reported Quality of Recovery
Patient reported quality of recovery based on survey
Measured: Baseline until 1 month after surgery
Hospital Antiemetic Usage
Total amount and type of antiemetic medication received while in the hospital
Measured: through hospital discharge, an average of two days after surgery
Cost of Hospital Stay
Total cost of hospital stay after surgery (including initial admission and any readmissions, ED visits, if applicable)
Measured: Up to 30 days after surgery
Weight Loss
Percent excess weight loss (EWL) and total weight loss (TWL) 1 week and 1 month after surgery
Measured: Up to 30 days after surgery
30-Day Events
Complications, ED Visits, Readmissions
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start3 Nov 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
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.
- More trials run by Thomas Jefferson 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Talar Tatarian, MD, Principal investigator, Jefferson Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644445
- Sponsor's protocol ID
- 20D.841
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2020
- Last updated
- 9 Dec 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 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-Protein Bariatric Diet on the Prevention of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04644445
- Acronym / sponsor ID
- 20D.841
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Postoperative Diet, Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 25 Nov 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.
Postoperative nausea and vomiting are common occurrences following bariatric surgery, occurring in up to 80% of patients and contributing to increased healthcare utilization and delays in discharge. This study aims to evaluate the impact of a high-protein liquid diet on postoperative nausea, vomiting, and length of stay after laparoscopic or robotic sleeve gastrectomy.
Detailed description
Patients with obesity or morbid obesity who are scheduled to undergoing robotic or laparoscopic sleeve gastrectomy will be screened at their preoperative visit. If they meet inclusion/exclusion criteria, they will be invited to participate in the study and written informed consent will be obtained. If the patient consents to participation, they will be randomized to either the control arm or intervention arm. All patients will undergo sleeve gastrectomy in a standard fashion, either laparoscopically or robotically, as discussed with their bariatric surgeon. Post-operative diet will be initiated 4 hours after surgery. The specific diet received will depend on which arm the patient is randomized into. Post-operative assessments will be completed at various time points for all patients. These include a Verbal Rating Scale of Nausea and Vomiting, Rhodes Index Survey, and Quality of Recover-15 Survey. All patients will track their oral intake on a spreadsheet which will be provided. Additional demographic and clinical data will be collected from the Electronic Medical Record. After hospital discharge, patients will follow up in the clinic one week and one month after surgery, per routine. After the one-month visit, the patient's study participation will be considered complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard bariatric clear liquid diet to be started 4 hours after surgery |
| Intervention | Experimental | Dietary Supplement: Bariatric Full Liquid DietBariatric full liquid diet (clear liquid diet + protein shakes) to be started 4 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient undergoing robotic or laparoscopic sleeve gastrectomy
- Patient able to provide written informed consent
- Patient able to understand and comply with study guidelines
Key exclusion criteria (6 listed)
- Inability to provide consent
- Previous history of bariatric or gastroesophageal surgery
- Chronic nausea/vomiting
- Hemoglobin A1C 9 or higher
- Therapeutic anticoagulation
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 |
|---|---|---|
| Bariatric Full Liquid DietPatient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery | Dietary supplement | Intervention |
Primary outcome
Postoperative nausea and vomiting related delay in hospital discharge
Time frame: through hospital discharge, an average of two days after surgery
Inability to be discharged from the hospital on postoperative day 1 due to postoperative nausea and vomiting. This will be measured by inability to maintain oral intake of 4-6 ounces an hour due to feeling of nausea or vomiting.
7 secondary outcomes
Length of Stay
Time frame: through hospital discharge, an average of two days after surgery
Severity of Postoperative Nausea and Vomiting
Time frame: Baseline until 1 month after surgery
Patient Self-Reported Quality of Recovery
Time frame: Baseline until 1 month after surgery
Hospital Antiemetic Usage
Time frame: through hospital discharge, an average of two days after surgery
Cost of Hospital Stay
Time frame: Up to 30 days after surgery
Weight Loss
Time frame: Up to 30 days after surgery
30-Day Events
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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.
Talar Tatarian, MD principal investigator
Jefferson Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Full Liquid Diet in people with Bariatric Surgery Candidate and Postoperative Nausea and Vomiting, run by Thomas Jefferson University at 2 sites in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talar Tatarian, MD (215-955-0020, talar.tatarian@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting related delay in hospital discharge (time frame: through hospital discharge, an average of two days after surgery). 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 9 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.