Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery... | NCT07018440

Studies
Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery: Effects on PONV and Recovery

NCT07018440

Sponsor

Marmara University

Status

Completed

Last Update Posted

Jun 12, 2025Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

Bariatric Surgery
Postoperative Nausea and Vomiting

Interventions

Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Feb 28, 2025Actual

Completion Date

Feb 28, 2025Actual

First Submitted Date

May 23, 2025

First Submission Date that Met QC Criteria

Jun 4, 2025

First Posted Date

Jun 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbohydrate Feeding Group	Experimental	Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RINVR Total Score	RINVR Total Score within 24 hours postoperative	Day 1
PORI Score	PORI Score at discharge and at 30-day follow-up	Day 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Scheduled for bariatric surgery
ASA score ≤ IV
Literate in Turkish and able to provide informed consent

Exclusion Criteria:

Use of antiemetics, steroids, or opioids within 24 hours pre-op
Need for ICU post-op
Reoperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HAMDİYE BANU KATRAN	Marmara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Education and Research Hospital		Istanbul	İ̇stanbul	34722	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared due to confidentiality concerns and institutional policy.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012996	Solutions

Ancestor Terms

ID	Term
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

Masking

Single

Masking Description

Due to the nature of the intervention, no blinding was applied to participants or investigators. However, outcome assessors and statisticians were blinded to group allocation to reduce bias during data analysis.

Who Masked

Outcomes Assessor