Thyroid Tumor
Conditions
Keywords
Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15
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.
Interventions
BEHAVIORALEarly resumption of oral intake
as above
BEHAVIORALLate resumption of oral intake
as above
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 score on the first day after surgery | one day | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | through patient discharge, an average of 3-4 day | 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 | through patient discharge, an average of 3-4 day | 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. |
| QoR-15 score on the day of discharge | one day | 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. |
| Length of hospital stay | through patient discharge, an average of 3-4 day | Length of hospital stay |
| Total drainage volume after operation | through removal of drainage tube, an average of 2 day | Total drainage volume after operation |
| Recovery of digestive function | through recovery of digestive function, an average of 1-2 day after surgery | Postoperative defecation and exhaustion time |
Countries
China
Contacts
Primary ContactShen Le, PhD
Backup ContactWu Juelun, Master
Outcome results
None listed