Bariatric SurgeryNCT07018440
Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery: Effects on PONV and Recovery
A study testing Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution) in people with Bariatric Surgery and Postoperative Nausea and Vomiting, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of preoperative oral administration of 200 ml 12.5% carbohydrate solution on postoperative nausea, vomiting, and recovery in bariatric surgery patients. The intervention group received carbohydrate loading two hours before surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery, Postoperative Nausea and Vomiting
- What is being tested?
- Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 28 Feb 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18
- Scheduled for bariatric surgery
- ASA score ≤ IV
- Literate in Turkish and able to provide informed consent
Who cannot join
- Use of antiemetics, steroids, or opioids within 24 hours pre-op
- Need for ICU post-op
- Reoperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Education and Research Hospital
Istanbul, İ̇stanbul, 34722
About this study
Official title: The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of preoperative oral administration of 200 ml 12.5% carbohydrate solution on postoperative nausea, vomiting, and recovery in bariatric surgery patients. The intervention group received carbohydrate loading two hours before surgery. Outcomes were measured using the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI).
Read the detailed description
This randomized controlled trial was designed to evaluate the effects of preoperative low-volume oral carbohydrate loading on postoperative nausea, vomiting, and recovery in patients undergoing bariatric surgery. A total of 105 adult patients scheduled for bariatric surgery were randomized into two groups: an intervention group (n = 53) and a control group (n = 52). The intervention group received 200 mL of a 12.5% carbohydrate solution orally two hours before surgery, while the control group followed standard preoperative fasting protocols without receiving any carbohydrate supplementation.
The primary hypothesis was that preoperative low-volume carbohydrate loading would reduce the frequency and severity of postoperative nausea, vomiting, and retching (PONV), and improve postoperative recovery. Data were collected using validated instruments including the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI). Outcomes were assessed within 24 hours postoperatively and at postoperative day 30.
Randomization was performed using computer-generated block randomization, and outcome assessment was blinded. The intervention was administered by a trained researcher, and standard postoperative nursing care protocols were applied to both groups.
- Being tested
- Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)
- Keywords
- Perioperative Nursing, Bariatric Surgery, Postoperative Nausea and Vomiting, Postoperative Recovery, Carbohydrate Feeding
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)Dietary supplement
Patients were given Low Volume Oral Carbohydrate feeding (200 mL 12.5% solution) in the preoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Feeding Group | Experimental | Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery. Receives: Dietary Supplement: Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution) |
| Control Group | No intervention | No carbohydrate solution provided; only standard fasting and care applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RINVR Total Score
RINVR Total Score within 24 hours postoperative
Measured: Day 1
PORI Score
PORI Score at discharge and at 30-day follow-up
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Nov 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
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.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a randomized, parallel-group design with two arms: an intervention group receiving low-volume oral carbohydrate loading before surgery, and a control group receiving standard care. Participants were allocated using computer-generated block randomization, and each participant received only one type of intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HAMDİYE BANU KATRAN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018440
- Sponsor's protocol ID
- OrCarBariatricNBSN
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to confidentiality concerns and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07018440
- Acronym / sponsor ID
- OrCarBariatricNBSN
- Keywords
- Perioperative Nursing, Bariatric Surgery, Postoperative Nausea and Vomiting, Postoperative Recovery, Carbohydrate Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Jun 2025 (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 randomized controlled trial aims to evaluate the effects of preoperative oral administration of 200 ml 12.5% carbohydrate solution on postoperative nausea, vomiting, and recovery in bariatric surgery patients. The intervention group received carbohydrate loading two hours before surgery. Outcomes were measured using the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI).
Detailed description
This randomized controlled trial was designed to evaluate the effects of preoperative low-volume oral carbohydrate loading on postoperative nausea, vomiting, and recovery in patients undergoing bariatric surgery. A total of 105 adult patients scheduled for bariatric surgery were randomized into two groups: an intervention group (n = 53) and a control group (n = 52). The intervention group received 200 mL of a 12.5% carbohydrate solution orally two hours before surgery, while the control group followed standard preoperative fasting protocols without receiving any carbohydrate supplementation.
The primary hypothesis was that preoperative low-volume carbohydrate loading would reduce the frequency and severity of postoperative nausea, vomiting, and retching (PONV), and improve postoperative recovery. Data were collected using validated instruments including the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI). Outcomes were assessed within 24 hours postoperatively and at postoperative day 30.
Randomization was performed using computer-generated block randomization, and outcome assessment was blinded. The intervention was administered by a trained researcher, and standard postoperative nursing care protocols were applied to both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a randomized, parallel-group design with two arms: an intervention group receiving low-volume oral carbohydrate loading before surgery, and a control group receiving standard care. Participants were allocated using computer-generated block randomization, and each participant received only one type of intervention.
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Feeding Group | Experimental | Dietary Supplement: Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery. |
| Control Group | No intervention | –No carbohydrate solution provided; only standard fasting and care applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Scheduled for bariatric surgery
- ASA score ≤ IV
- Literate in Turkish and able to provide informed consent
Key exclusion criteria (3 listed)
- Use of antiemetics, steroids, or opioids within 24 hours pre-op
- Need for ICU post-op
- Reoperation
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 |
|---|---|---|
| Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)Patients were given Low Volume Oral Carbohydrate feeding (200 mL 12.5% solution) in the preoperative period. | Dietary supplement | Carbohydrate Feeding Group |
Primary outcome
RINVR Total Score
Time frame: Day 1
RINVR Total Score within 24 hours postoperative
PORI Score
Time frame: Day 30
PORI Score at discharge and at 30-day follow-up
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 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality concerns and institutional policy.
Related trials for Bariatric Surgery
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
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.
HAMDİYE BANU KATRAN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution) in people with Bariatric Surgery and Postoperative Nausea and Vomiting, run by Marmara University 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 4 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 2025. 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?
RINVR Total Score (time frame: Day 1). The study lists 2 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 12 Jun 2025.