Back to resultsEffect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
Primary Purpose
Thyroid Tumor
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early resumption of oral intake
Late resumption of oral intake
Sponsored by
About this trial
This is an interventional supportive care trial for Thyroid Tumor focused on measuring Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- ASA Physical Status I-II
- Body mass index 18.5-29.9kg/m2
- First operation on operation day
- Thyroid surgery
Exclusion Criteria:
- Patients or family members cannot understand the conditions and objectives of this study
- Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
- 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)
- 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)
Sites / Locations
- Wu Juelun
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early resumption of oral intake
Late resumption of oral intake
Arm Description
Drink 30-50ML of normal temperature water after meeting the PACU transfer out standard. If the patient swallows successfully and does not cough, after returning to the ward, the medical staff of the ward will guide him or her to resume drinking and eating early: patient will resume drinking water within one hour after returning to the ward, a small amount of water for many times until the amount of drinking water reaches 300ml. If the patient does not have discomfort symptoms, he or she will resume eating according to normal drinking and eating habits.
Drink 30-50ML of normal temperature water after 6h after the operation. A small amount of water can be used several times, and the amount of water can reach 300ml. If the patient does not have any discomfort symptoms, it can guide the patient to recover diet according to his/her normal eating habits.
Outcomes
Primary Outcome Measures
QoR-15 score on the first day after surgery
Using QoR-15 questionnaire to evaluate the quality of perioperative recovery. QoR-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the QoR-15 score of the patient.
Secondary Outcome Measures
QoR-15 score on the day of discharge
Using QoR-15 questionnaire to evaluate the quality of perioperative recovery. QoR-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the QoR-15 score of the patient.
Patient satisfaction
The overall satisfaction of the patients during hospitalization was scored immediately before the patients were discharged from the hospital. The patients were scored according to 0-10 points, 0 being completely dissatisfied and 10 being completely satisfied.
Postoperative pain
The patients were given self-evaluation before the first drinking water and 8 hours after the operation. They were divided into pharyngeal pain and surgical incision pain, which were scored according to 0-10 points respectively. 0 point was completely painless, and 10 point was unbearable pain.
Recovery of digestive function
Postoperative defecation and exhaustion time
Length of hospital stay
Length of hospital stay
Total drainage volume after operation
Total drainage volume after operation
Full Information
NCT ID
NCT05532384
First Posted
August 30, 2022
Last Updated
November 13, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05532384
Brief Title
Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
Official Title
Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Tumor
Keywords
Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early resumption of oral intake
Arm Type
Experimental
Arm Description
Drink 30-50ML of normal temperature water after meeting the PACU transfer out standard. If the patient swallows successfully and does not cough, after returning to the ward, the medical staff of the ward will guide him or her to resume drinking and eating early: patient will resume drinking water within one hour after returning to the ward, a small amount of water for many times until the amount of drinking water reaches 300ml. If the patient does not have discomfort symptoms, he or she will resume eating according to normal drinking and eating habits.
Arm Title
Late resumption of oral intake
Arm Type
Other
Arm Description
Drink 30-50ML of normal temperature water after 6h after the operation. A small amount of water can be used several times, and the amount of water can reach 300ml. If the patient does not have any discomfort symptoms, it can guide the patient to recover diet according to his/her normal eating habits.
Intervention Type
Behavioral
Intervention Name(s)
Early resumption of oral intake
Intervention Description
as above
Intervention Type
Behavioral
Intervention Name(s)
Late resumption of oral intake
Intervention Description
as above
Primary Outcome Measure Information:
Title
QoR-15 score on the first day after surgery
Description
Using QoR-15 questionnaire to evaluate the quality of perioperative recovery. QoR-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the QoR-15 score of the patient.
Time Frame
one day
Secondary Outcome Measure Information:
Title
QoR-15 score on the day of discharge
Description
Using QoR-15 questionnaire to evaluate the quality of perioperative recovery. QoR-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the QoR-15 score of the patient.
Time Frame
one day
Title
Patient satisfaction
Description
The overall satisfaction of the patients during hospitalization was scored immediately before the patients were discharged from the hospital. The patients were scored according to 0-10 points, 0 being completely dissatisfied and 10 being completely satisfied.
Time Frame
through patient discharge, an average of 3-4 day
Title
Postoperative pain
Description
The patients were given self-evaluation before the first drinking water and 8 hours after the operation. They were divided into pharyngeal pain and surgical incision pain, which were scored according to 0-10 points respectively. 0 point was completely painless, and 10 point was unbearable pain.
Time Frame
through patient discharge, an average of 3-4 day
Title
Recovery of digestive function
Description
Postoperative defecation and exhaustion time
Time Frame
through recovery of digestive function, an average of 1-2 day after surgery
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
through patient discharge, an average of 3-4 day
Title
Total drainage volume after operation
Description
Total drainage volume after operation
Time Frame
through removal of drainage tube, an average of 2 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18
ASA Physical Status I-II
Body mass index 18.5-29.9kg/m2
First operation on operation day
Thyroid surgery
Exclusion Criteria:
Patients or family members cannot understand the conditions and objectives of this study
Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
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)
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Le, PhD
Phone
13810248138
Email
pumchshenle@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Juelun, Master
Phone
18707486338
Email
18707486338@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Le, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Wu Juelun
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Juelun, Master
Phone
18707486338
Email
18707486338@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
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