Clinical trial NCT05955495: Length of Stay Between Early Versus Delayed Oral Postoperative Feeding
Official title: Length of Stay Between Early Versus Delayed Oral Postoperative Feeding After Gynecologic Surgery Under General Anesthesia: Randomized Controlled Trial, Single Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Feeding
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 34
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomized (1:1 computerized block randomization) into two groups. One group is early feeding and another is delayed feeding.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: 12 months
Secondary outcomes:
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Chuenrutai Yeekian
Study officials:
affiliation: Queen SVMH
name: Penpilai Vinitchaikul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.