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

NCT05532384 | Unknown DMC

• 1 other identifier: ZS-3566
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Thyroid Tumor

Keywords

Thyroidectomy; Enhanced Recovery After Surgery; Quality of Recovery-15

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• QoR-15 score on the day of discharge

  one day

• Patient satisfaction

  through patient discharge, an average of 3-4 day

• Postoperative pain

  through patient discharge, an average of 3-4 day

• Recovery of digestive function

  through recovery of digestive function, an average of 1-2 day after surgery

• Length of hospital stay

  through patient discharge, an average of 3-4 day

Study Arms (2)

Early resumption of oral intake

EXPERIMENTAL

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

Late resumption of oral intake

OTHER

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

Interventions

Early resumption of oral intake BEHAVIORAL

as above

Early resumption of oral intake

Late resumption of oral intake BEHAVIORAL

as above

Late resumption of oral intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• ASA Physical Status I-II
• Body mass index 18.5-29.9kg/m2
• First operation on operation day
• Thyroid surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Wu Juelun

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Shen Le, PhD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Shen Le, PhD

CONTACT

13810248138; pumchshenle@163.com

Wu Juelun, Master

CONTACT

18707486338; 18707486338@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 8, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)