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Clinical Trials/NCT05532384
NCT05532384UnknownNot Applicable

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

Peking Union Medical College Hospital1 site in 1 country94 target enrollmentStarted: December 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
94
Locations
1
Primary Endpoint
QoR-15 score on the first day after surgery

Study Overview

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.

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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:
  • •Unable to understand words and language;
  • •Difficult to cooperate due to mental disorders;
  • •History of alcohol or drug abuse;
  • •Any serious pre-existing medical condition that can limit the objective evaluation after surgery;
  • •Any life-threatening complications;
  • •Emergency surgery)

Arms & Interventions

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.

Intervention: Early resumption of oral intake (Behavioral)

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.

Intervention: Late resumption of oral intake (Behavioral)

Outcomes

Primary Outcomes

QoR-15 score on the first day after surgery

Time Frame: 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 Outcomes

  • Postoperative pain(through patient discharge, an average of 3-4 day)
  • QoR-15 score on the day of discharge(one day)
  • Patient satisfaction(through patient discharge, an average of 3-4 day)
  • Length of hospital stay(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)
  • Total drainage volume after operation(through removal of drainage tube, an average of 2 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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