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LOS: Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05955495
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
7.4
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Food
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The participants were randomized (1:1 computerized block randomization) into two groups. One group is early feeding and another is delayed feeding.The participants were randomized (1:1 computerized block randomization) into two groups. One group is early feeding and another is delayed feeding.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Length of Stay Between Early Versus Delayed Oral Postoperative Feeding After Gynecologic Surgery Under General Anesthesia: Randomized Controlled Trial, Single Center
Actual Study Start Date :
Apr 19, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Delayed feeding

Other: Food
Post-operative feeding includes water, liquid diet, soft diet.
Experimental: Early feeding

Other: Food
Post-operative feeding includes water, liquid diet, soft diet.

Outcome Measures

Primary Outcome Measures

  1. Length of stay [12 months]

    Length of stay between early versus delayed oral postoperative feeding

Secondary Outcome Measures

  1. Complications [12 months]

    Complications occur during postoperative feeding between two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chuenrutai Yeekian Chon Buri Thailand 20110

Sponsors and Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

  • Principal Investigator: Penpilai Vinitchaikul, MD, Queen SVMH

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Queen Savang Vadhana Memorial Hospital, Thailand
ClinicalTrials.gov Identifier:
NCT05955495
Other Study ID Numbers:
  • 002/2566
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2023