Length of Stay Between Early Versus Delayed Oral Postoper... | NCT05955495

Studies
Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

NCT05955495

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Unknown status

Last Update Posted

Apr 4, 2024Actual

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Early Feeding

Interventions

Food

Countries

Thailand

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2023Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jul 13, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 21, 2023Actual

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

Apr 2, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Length of stay between early versus delayed oral postoperative feeding after gynecologic surgery under General Anesthesia: Randomized Controlled Trial, single center

The goal of this Randomized Controlled Trial is to compare Length of stay between early versus delayed oral postoperative feeding after gynecologic surgery under General Anesthesia. The main question[s] it aims to answer are:

Length of stay
Complications Participants will randomized (1:1 block randomization ) into Group A or B. The comparison groups are early and delayed postoperative feeding.

Detailed Description

Not provided

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

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delayed feeding	Active Comparator		Other: Food
Early feeding	Experimental		Other: Food

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food	Other	Post-operative feeding includes water, liquid diet, soft diet.	Delayed feeding Early feeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay	Length of stay between early versus delayed oral postoperative feeding	12 months

Secondary Outcomes

Measure	Description	Time Frame
Complications	Complications occur during postoperative feeding between two groups	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants undergoing gynecologic surgery with stable vital signs
Participants undergoing abdominal gynecologic surgery
No evidence of malignancy
No underlying disease relating to GI system
Not currently having gut obstruction
No previous abdominal surgeries aside from appendectomy
Previous history of abdominal radiation

Exclusion Criteria:

Transferred to ICU postoperatively
on ETT, NG
Participants with immediate complications from operation
No informed consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women presenting with gynecologic condition.

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

Name	Role	Phone	Extension	Email
Cheunrutai Yeekian, PhD	Contact	+6638322157	3460	jayeekian88@gmail.com
Wanna Sermklin, Bsc	Contact	+6638322157	1182	wannanook04@gmail.com

Overall Officials

Name	Affiliation	Role
Penpilai Vinitchaikul, MD	Queen SVMH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chuenrutai Yeekian	Recruiting	Chon Buri		20110	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25502897	Background	Charoenkwan K, Matovinovic E. Early versus delayed oral fluids and food for reducing complications after major abdominal gynaecologic surgery. Cochrane Database Syst Rev. 2014 Dec 12;2014(12):CD004508. doi: 10.1002/14651858.CD004508.pub4.
30134426	Background	ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818.

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages