Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery

Thyroid Tumor Clinical Trial

Official title:

Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05532384
• Other study ID #: ZS-3566
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2022
• Source: Peking Union Medical College Hospital
• Contact: Shen Le, PhD
• Phone: 13810248138
• Email: pumchshenle[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Tumor

Intervention

Behavioral:
• Early resumption of oral intake
as above
• Late resumption of oral intake
as above

Locations

Country	Name	City	State
China	Wu Juelun	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Secondary	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.	one day
Secondary	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.	through patient discharge, an average of 3-4 day
Secondary	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.	through patient discharge, an average of 3-4 day
Secondary	Recovery of digestive function	Postoperative defecation and exhaustion time	through recovery of digestive function, an average of 1-2 day after surgery
Secondary	Length of hospital stay	Length of hospital stay	through patient discharge, an average of 3-4 day
Secondary	Total drainage volume after operation	Total drainage volume after operation	through removal of drainage tube, an average of 2 day