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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Tumor
• Intervention / Treatment: Behavioral: Early resumption of oral intake; Behavioral: Late resumption of oral intake

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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shen Le, PhD; Phone Number: 13810248138; Email: pumchshenle@163.com
• Study Contact Backup: Name: Wu Juelun, Master; Phone Number: 18707486338; Email: 18707486338@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Wu Juelun
      • Contact: Wu Juelun, Master; Phone Number: 18707486338; Email: 18707486338@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early resumption of oral intake; 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.	Behavioral: Early resumption of oral intake; as above
Other: Late resumption of oral intake; 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.	Behavioral: Late resumption of oral intake; as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length of hospital stay	Length of hospital stay	through patient discharge, an average of 3-4 day
Total drainage volume after operation	Total drainage volume after operation	through removal of drainage tube, an average of 2 day
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
Recovery of digestive function	Postoperative defecation and exhaustion time	through recovery of digestive function, an average of 1-2 day after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Shen Le, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Enhanced Recovery After Surgery; Thyroidectomy; Quality of Recovery-15
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: ZS-3566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No