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Trial Title:
Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
NCT ID:
NCT05532384
Condition:
Thyroid Tumor
Conditions: Official terms:
Thyroid Diseases
Conditions: Keywords:
Thyroidectomy
Enhanced Recovery After Surgery
Quality of Recovery-15
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial：Participants who enroll in RCTs differ from one another in
known and unknown ways that can influence study outcomes, and yet cannot be directly
controlled. By randomly allocating participants among compared treatments, an RCT enables
statistical control over these influences. Provided it is designed well, conducted
properly, and enrolls enough participants, an RCT may achieve sufficient control over
these confounding factors to deliver a useful comparison of the treatments studied.
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
The anesthesiologists will obtain the group of patients through computer randomization
before the patients leave the Post-Anesthesia Care Unit, and guide the patients to drink
water. The questionnaire collectors and outcomes assessor will not be informed of the
group of patients.
Intervention:
Intervention type:
Behavioral
Intervention name:
Early resumption of oral intake
Description:
as above
Arm group label:
Early resumption of oral intake
Intervention type:
Behavioral
Intervention name:
Late resumption of oral intake
Description:
as above
Arm group label:
Late resumption of oral intake
Summary:
This study is a single-center, prospective and randomized controlled study to investigate
the effects of early recovery of oral intake (E) and late recovery of oral intake (L) on
postoperative recovery quality and satisfaction of patients undergoing thyroid surgery.
The study's primary outcome is quality of recovery-15 scale (Qor-15).
Detailed description:
The subjects of this study are patients who will receive thyroid surgery in Peking Union
Medical College Hospital. After the patient is included in the experiment, when the
patient meets the exit criteria of the PACU, the patient will be randomly assigned to
early resumption of oral intake group and late resumption of oral intake group to receive
different treatments. Finally, researchers will collecte and evaluate the different
outcome indicators of the two groups of patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18
2. ASA Physical Status I-II
3. Body mass index 18.5-29.9kg/m2
4. First operation on operation day
5. Thyroid surgery
Exclusion Criteria:
1. Patients or family members cannot understand the conditions and objectives of this
study
2. Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high
risk of aspiration
3. The surgeons or anesthesiologists point out that the patient is not suitable for
early postoperative drinking (such as considering the injury of recurrent laryngeal
nerve or lymphatic vessels during the operation)
4. Exclusion criteria of QoR-15* (*QoR-15 exclusion criteria: 1. Unable to understand
words and language; 2. Difficult to cooperate due to mental disorders; 3. History of
alcohol or drug abuse; 4. Any serious pre-existing medical condition that can limit
the objective evaluation after surgery; 5. Any life-threatening complications; 6.
Emergency surgery)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wu Juelun
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Wu Juelun, Master
Phone:
18707486338
Email:
18707486338@163.com
Start date:
December 1, 2022
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05532384
