Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

NCT05955495 | Recruiting DMC

• 1 other identifier: 002/2566
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Feeding

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Length of stay between early versus delayed oral postoperative feeding

  12 months

Secondary Outcomes (1)

• Complications

  12 months

Study Arms (2)

Delayed feeding

ACTIVE COMPARATOR

Other: Food

Early feeding

EXPERIMENTAL

Other: Food

Interventions

Food OTHER

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

Delayed feeding; Early feeding

Eligibility Criteria

• Gender Eligibility Details: Women presenting with gynecologic condition.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Chuenrutai Yeekian

Chon Buri, 20110, Thailand

RECRUITING

Related Publications (10)

• 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.

  PMID: 25502897 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.

  PMID: 30134426 BACKGROUND

• 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.

  PMID: 35396709 BACKGROUND

• 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.

  PMID: 18650627 BACKGROUND

• 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.

  PMID: 30877144 BACKGROUND

• 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.

  PMID: 3140573 BACKGROUND

• 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.

  PMID: 27466536 BACKGROUND

• 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.

  PMID: 26799328 BACKGROUND

• 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.

  PMID: 27521884 BACKGROUND

• 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.

  PMID: 26637080 BACKGROUND

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Penpilai Vinitchaikul, MD

  Queen SVMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheunrutai Yeekian, PhD

CONTACT

+6638322157; jayeekian88@gmail.com

Wanna Sermklin, Bsc

CONTACT

+6638322157; wannanook04@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: April 19, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

TH (1)