NCT05005091

Brief Summary

Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 8, 2021

Last Update Submit

August 12, 2021

Conditions

Non Small Cell Lung CancerFastingPostoperative Pneumonia

Keywords

Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery

Outcome Measures

Primary Outcomes (1)

  • Mobilization time

    postoperative mobilization

    1 hour

Study Arms (2)

oral carbohydrate

ACTIVE COMPARATOR

the patients drunk oral carbohydrate two hours ago preoperatively

Dietary Supplement: Oral carbohydrate

no oral carbohydrate

NO INTERVENTION

the patients did not drink oral carbohydrate preoperatively

Interventions

Oral carbohydrateDIETARY_SUPPLEMENT

100 ml oral carbohydrate two hours ago preoperatively

oral carbohydrate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage I-Stage II all operable NSCLC patients -

You may not qualify if:

  • Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

health Science University, Sureyyapa Training and Research Hospital

Istanbul, 34857, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungFasting

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SureyyapasaM

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 13, 2021

Study Start

January 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)