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

NCT ID: NCT05532384

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Thyroid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Early resumption of oral intake

Intervention Type BEHAVIORAL

as above

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.

Group Type OTHER

Late resumption of oral intake

Intervention Type BEHAVIORAL

as above

Interventions

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Early resumption of oral intake

as above

Intervention Type BEHAVIORAL

Late resumption of oral intake

as above

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shen Le, PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Wu Juelun

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shen Le, PhD

Role: CONTACT

13810248138

Wu Juelun, Master

Role: CONTACT

18707486338

Facility Contacts

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Wu Juelun, Master

Role: primary

18707486338

Other Identifiers

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ZS-3566

Identifier Type: -

Identifier Source: org_study_id

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