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RecruitingNCT05955495LOSUpdated Apr 4, 2024

Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

An interventional study of Food in Early Feeding, sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. Recruiting at 1 site in Thailand. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Queen Savang Vadhana Memorial Hospital, Thailand · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Sex
Female
01

Study 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.
02

Conditions studied

  • Early Feeding
03

In context

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand is the lead sponsor of 29 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Transferred to ICU postoperatively
  • on ETT, NG
  • Participants with immediate complications from operation
  • No informed consent
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Delayed feeding

    Other: Food

  • Experimental
    Early feeding

    Other: Food

Interventions

  • OtherFood

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

06

What researchers measure

Primary outcomes

  1. Length of stay

    Length of stay between early versus delayed oral postoperative feeding

    Time frame: 12 months

Secondary outcomes

  1. Complications

    Complications occur during postoperative feeding between two groups

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 25502897 ↗
  • ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818. Erratum In: Obstet Gynecol. 2019 Jun;133(6):1288. doi: 10.1097/AOG.0000000000003312. Obstet Gynecol. 2019 Nov;134(5):1121. doi: 10.1097/AOG.0000000000003569. PubMed 30134426 ↗
  • 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. PubMed 35396709 ↗
  • 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. PubMed 18650627 ↗
  • 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. PubMed 30877144 ↗
  • 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. PubMed 3140573 ↗
  • 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. PubMed 27466536 ↗
  • 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. PubMed 26799328 ↗
  • 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. PubMed 27521884 ↗
  • 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. PubMed 26637080 ↗

Individual participant data

Plan to share: Undecided — Data were input in Excel spreadsheet and SPSS

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05955495
Lead sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Responsible party
Sponsor
First posted
Jul 21, 2023
Start date
Apr 19, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 4, 2024

Study contacts

Cheunrutai Yeekian, PhD
Contact
jayeekian88@gmail.com
+6638322157 ext. 3460
Wanna Sermklin, Bsc
Contact
wannanook04@gmail.com
+6638322157 ext. 1182
Penpilai Vinitchaikul, MD
principal investigator · Queen SVMH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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