Length of Stay Between Early Versus Delayed Oral Postoperative Feeding

Early Feeding Clinical Trial

— LOS  

Official title:

Length of Stay Between Early Versus Delayed Oral Postoperative Feeding After Gynecologic Surgery Under General Anesthesia: Randomized Controlled Trial, Single Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955495
• Other study ID #: 002/2566
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: Cheunrutai Yeekian, PhD
• Phone: +6638322157
• Email: jayeekian88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Early Feeding

Intervention

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

Locations

Country	Name	City	State
Thailand	Chuenrutai Yeekian	Chon Buri

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

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. Obstet Gynecol. 2019 Nov;134(5):1121. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Length of stay between early versus delayed oral postoperative feeding	12 months
Secondary	Complications	Complications occur during postoperative feeding between two groups	12 months