Thyroid TumorNCT05532384
Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
A study testing Early resumption of oral intake and Late resumption of oral intake in people with Thyroid Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Tumor
- What is being tested?
- Early resumption of oral intake and Late resumption of oral intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- ASA Physical Status I-II
- Body mass index 18.5-29.9kg/m2
- First operation on operation day
- Thyroid surgery
Who cannot join
- 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: 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Wu Juelun
Beijing, Beijing Municipality
Wu Juelun, Master, 18707486338, 18707486338@163.com
About this study
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).
Read the 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.
- Conditions
- Thyroid Tumor
- Being tested
- Early resumption of oral intake, Late resumption of oral intake
- Keywords
- Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early resumption of oral intakeBehavioural
as above
Late resumption of oral intakeBehavioural
as above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Late resumption of oral intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (6)
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.
Measured: one day
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.
Measured: 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.
Measured: through patient discharge, an average of 3-4 day
Recovery of digestive function
Postoperative defecation and exhaustion time
Measured: through recovery of digestive function, an average of 1-2 day after surgery
Length of hospital stay
Length of hospital stay
Measured: through patient discharge, an average of 3-4 day
Total drainage volume after operation
Total drainage volume after operation
Measured: through removal of drainage tube, an average of 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shen Le, PhD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532384
- Sponsor's protocol ID
- ZS-3566
- Status last verified
- Jun 2022
- First submitted
- 30 Aug 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05532384
- Acronym / sponsor ID
- ZS-3566
- Conditions
- Thyroid Tumor
- Keywords
- Thyroidectomy, Enhanced Recovery After Surgery, Quality of Recovery-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early resumption of oral intake | Experimental | Behavioral: Early resumption of oral intakeDrink 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. |
| Late resumption of oral intake | Other | Behavioral: Late resumption of oral intakeDrink 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- ASA Physical Status I-II
- Body mass index 18.5-29.9kg/m2
- First operation on operation day
- Thyroid surgery
Key exclusion criteria (4 listed)
- 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: 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early resumption of oral intakeas above | Behavioural | Early resumption of oral intake |
| Late resumption of oral intakeas above | Behavioural | Late resumption of oral intake |
Primary outcome
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.
6 secondary outcomes
QoR-15 score on the day of discharge
Time frame: one day
Patient satisfaction
Time frame: through patient discharge, an average of 3-4 day
Postoperative pain
Time frame: through patient discharge, an average of 3-4 day
Recovery of digestive function
Time frame: through recovery of digestive function, an average of 1-2 day after surgery
Length of hospital stay
Time frame: through patient discharge, an average of 3-4 day
Total drainage volume after operation
Time frame: through removal of drainage tube, an average of 2 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Le, PhD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early resumption of oral intake and Late resumption of oral intake in people with Thyroid Tumor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shen Le, PhD (13810248138, pumchshenle@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 score on the first day after surgery (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.