Clinical trial NCT05532384: Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
Official title: Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Tumor
Keywords: Thyroidectomy
Enhanced Recovery After Surgery
Quality of Recovery-15
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: QoR-15 score on the first day after surgery
timeFrame: one day
Secondary outcomes:
measure: QoR-15 score on the day of discharge
timeFrame: one day
measure: Patient satisfaction
timeFrame: through patient discharge, an average of 3-4 day
measure: Postoperative pain
timeFrame: through patient discharge, an average of 3-4 day
measure: Recovery of digestive function
timeFrame: through recovery of digestive function, an average of 1-2 day after surgery
measure: Length of hospital stay
timeFrame: through patient discharge, an average of 3-4 day
measure: Total drainage volume after operation
timeFrame: through removal of drainage tube, an average of 2 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wu Juelun
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shen Le, PhD
role: STUDY_CHAIR
References: