Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

NCT ID: NCT05955495

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-19

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Early Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were randomized (1:1 computerized block randomization) into two groups. One group is early feeding and another is delayed feeding.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Delayed feeding

Group Type ACTIVE_COMPARATOR

Food

Intervention Type OTHER

Post-operative feeding includes water, liquid diet, soft diet.

Early feeding

Group Type EXPERIMENTAL

Food

Intervention Type OTHER

Post-operative feeding includes water, liquid diet, soft diet.

Interventions

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Food

Post-operative feeding includes water, liquid diet, soft diet.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Penpilai Vinitchaikul, MD

Role: PRINCIPAL_INVESTIGATOR

Queen SVMH

Locations

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Chuenrutai Yeekian

Chon Buri, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Cheunrutai Yeekian, PhD

Role: CONTACT

+6638322157 ext. 3460

Wanna Sermklin, Bsc

Role: CONTACT

+6638322157 ext. 1182

Facility Contacts

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Chuenrutai Yeekian, PhD

Role: primary

+6638322157 ext. 3460

Wanna Sermklin, Bsc

Role: backup

Yeekian ext. 1182

References

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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.

Reference Type BACKGROUND
PMID: 25502897 (View on PubMed)

ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818.

Reference Type BACKGROUND
PMID: 30134426 (View on PubMed)

Chiewhatpong P, Charoenkwan K, Smithiseth K, Lapisatepun W, Lapisatepun P, Phimphilai M, Muangmool T, Cheewakriangkrai C, Suprasert P, Srisomboon J. Effectiveness of enhanced recovery after surgery protocol in open gynecologic oncology surgery: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Nov;159(2):568-576. doi: 10.1002/ijgo.14211. Epub 2022 Apr 21.

Reference Type BACKGROUND
PMID: 35396709 (View on PubMed)

Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.

Reference Type BACKGROUND
PMID: 18650627 (View on PubMed)

Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

Reference Type BACKGROUND
PMID: 30877144 (View on PubMed)

Hessov I, Rylev Larsen K, Sondergaard K. Improved early alimentation after radical hysterectomies without the traditional use of stomach tube. Acta Obstet Gynecol Scand. 1988;67(3):225-8. doi: 10.3109/00016348809004208.

Reference Type BACKGROUND
PMID: 3140573 (View on PubMed)

Muallem MZ, Dimitrova D, Pietzner K, Richter R, Feldheiser A, Scharfe I, Schmeil I, Hosl TM, Mustea A, Wimberger P, Burges A, Kimmig R, Sehouli J. Implementation of Enhanced Recovery After Surgery (ERAS) Pathways in Gynecologic Oncology. A NOGGO-AGO* survey of 144 Gynecological Departments in Germany. Anticancer Res. 2016 Aug;36(8):4227-32.

Reference Type BACKGROUND
PMID: 27466536 (View on PubMed)

Wijk L, Franzen K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

Reference Type BACKGROUND
PMID: 26799328 (View on PubMed)

Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

Reference Type BACKGROUND
PMID: 27521884 (View on PubMed)

Balayla J, Bujold E, Lapensee L, Mayrand MH, Sansregret A. Early Versus Delayed Postoperative Feeding After Major Gynaecological Surgery and its Effects on Clinical Outcomes, Patient Satisfaction, and Length of Stay: A Randomized Controlled Trial. J Obstet Gynaecol Can. 2015 Dec;37(12):1079-85. doi: 10.1016/s1701-2163(16)30073-1.

Reference Type BACKGROUND
PMID: 26637080 (View on PubMed)

Other Identifiers

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002/2566

Identifier Type: -

Identifier Source: org_study_id

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