Length of Stay Between Early Versus Delayed Oral Postoperative Feeding
NCT ID: NCT05955495
Last Updated: 2024-04-04
Study Results
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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RECRUITING
NA
34 participants
INTERVENTIONAL
2023-04-19
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Delayed feeding
Food
Post-operative feeding includes water, liquid diet, soft diet.
Early feeding
Food
Post-operative feeding includes water, liquid diet, soft diet.
Interventions
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Food
Post-operative feeding includes water, liquid diet, soft diet.
Eligibility Criteria
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Inclusion Criteria
* 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
* on ETT, NG
* Participants with immediate complications from operation
* No informed consent
FEMALE
Yes
Sponsors
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Queen Savang Vadhana Memorial Hospital, Thailand
OTHER
Responsible Party
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Principal Investigators
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Penpilai Vinitchaikul, MD
Role: PRINCIPAL_INVESTIGATOR
Queen SVMH
Locations
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Chuenrutai Yeekian
Chon Buri, , Thailand
Countries
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Central Contacts
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Facility Contacts
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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.
ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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002/2566
Identifier Type: -
Identifier Source: org_study_id
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