Postoperative ComplicationsNCT04599231
Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer
A study testing Quality of Recovery -15 in people with Postoperative Complications and Anxiety, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by Quality of Recovery-15 (QOR-15). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Anxiety, Depression
- What is being tested?
- Quality of Recovery -15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2020to 24 Aug 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy) under general anesthesia
- ASA status I or II
- Able to read and understand the information sheet, the questionnaires, and the consent form.
Who cannot join
- Unable to read and understand the information sheet, the questionnaires, and the consent form.
- Age above 80 years
- WIth severe medical or psychological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
This study aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by Quality of Recovery-15 (QOR-15). The findings of the study would improve the perioperative management of early gastric cancer patients.
Read the detailed description
The researchers plan to investigate preoperative psychological factors such as anxiety, depression, and coping strategy in association with short-term quality of recovery from surgery in 100 patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy).
The following items are investigated before surgery; Age, sex, BMI, level of education, occupation, marital status, ECOG performance status, ASA physical status, Apfel score, history of mental disorder, type of surgery, past surgical history, the number of days from diagnosis of cancer to surgery, clinical stage of cancer, histological type of cancer, presence of chronic pain, Quality of Recovery-15 (QOR-15), Hospital Anxiety and Depression Scale (HADS), Amsterdam Preoperative Anxiety and Information Scale (APAIS), Coping and Adaptation Scale-Short Form (CAPS-SF).
The QOR-15 is investigated for 24, 48, and 72 hours after surgery. The severity of postoperative pain by the 11-point Numerical Rating Scale (NRS) is concurrently measured at 24, 48, and 72 hours after surgery. In addition, the researchers measure postoperative complications, particularly nausea/vomiting, at 24, 48, and 72 hours after surgery and length of stay by counting the number of days from the day of surgery to discharge.
- Conditions
- Postoperative Complications, Anxiety, Depression, Coping Behavior
- Being tested
- Quality of Recovery -15
- Keywords
- Postoperative Complications, Anxiety, Depression, Coping Behavior
- Medical subject headings
- Postoperative Complications, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Recovery -15Diagnostic test
The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The investigators would perform the following tests preoperatively on the study subjects.
1. Hospital Anxiety and Depression Scale (HADS)
2. Amsterdam Preoperative Anxiety and Information Scale (APAIS)
3. Coping and Adaptation Processing Scale-Short Form (CAPS-SF)
4. Quality of Recovery -15 (QOR-15) Receives: Diagnostic Test: Quality of Recovery -15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery -15 score at postoperative 72 hours
There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)
Measured: at postoperative 72 hours
Secondary outcomes (5)
Quality of Recovery -15 score at postoperative 24 hours
There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)
Measured: at postoperative 24 hours
Quality of Recovery -15 score at postoperative 48 hours
There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)
Measured: at postoperative 48 hours
Postoperative pain score
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Measured: at postoperative 24, 48, and 72 hours
Length of stay
The number of days that patients spend in the hospital after surgery
Measured: through study completion, an average of 1 year
Postoperative nausea or vomiting
Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics
Measured: at postoperative 24, 48, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start12 Oct 2020 (estimated)
- Primary completion24 Jun 2021 (estimated)
- Study completion24 Aug 2021 (estimated)
Why it stopped: Considering the various conditions (other ongoing prospective studies, lack of manpower), we decided not to proceed with this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, Seoul National University Hospital
- Investigators
- Hojin Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599231
- Sponsor's protocol ID
- 2008-130-1149
- Status last verified
- Dec 2022
- First submitted
- 6 Oct 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon S, Joo H, Oh YM, Lee J, Bahk JH, Lee HJ. Validation and clinical utility of the Korean version of the Quality of Recovery-15 with enhanced recovery after surgery: a prospective observational cohort study. Br J Anaesth. 2020 Oct;125(4):614-621. doi: 10.1016/j.bja.2020.06.040. Epub 2020 Jul 21.
PubMed 32703550Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT04599231
- Acronym / sponsor ID
- 2008-130-1149
- Conditions
- Postoperative Complications, Anxiety, Depression, Coping Behavior
- Keywords
- Postoperative Complications, Anxiety, Depression, Coping Behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Considering the various conditions (other ongoing prospective studies, lack of manpower), we decided not to proceed with this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Oct 2020 (estimated)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 24 Aug 2021 (estimated)
- First posted
- 22 Oct 2020 (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 aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by Quality of Recovery-15 (QOR-15). The findings of the study would improve the perioperative management of early gastric cancer patients.
Detailed description
The researchers plan to investigate preoperative psychological factors such as anxiety, depression, and coping strategy in association with short-term quality of recovery from surgery in 100 patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy).
The following items are investigated before surgery; Age, sex, BMI, level of education, occupation, marital status, ECOG performance status, ASA physical status, Apfel score, history of mental disorder, type of surgery, past surgical history, the number of days from diagnosis of cancer to surgery, clinical stage of cancer, histological type of cancer, presence of chronic pain, Quality of Recovery-15 (QOR-15), Hospital Anxiety and Depression Scale (HADS), Amsterdam Preoperative Anxiety and Information Scale (APAIS), Coping and Adaptation Scale-Short Form (CAPS-SF).
The QOR-15 is investigated for 24, 48, and 72 hours after surgery. The severity of postoperative pain by the 11-point Numerical Rating Scale (NRS) is concurrently measured at 24, 48, and 72 hours after surgery. In addition, the researchers measure postoperative complications, particularly nausea/vomiting, at 24, 48, and 72 hours after surgery and length of stay by counting the number of days from the day of surgery to discharge.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: Quality of Recovery -15The investigators would perform the following tests preoperatively on the study subjects. 1. Hospital Anxiety and Depression Scale (HADS) 2. Amsterdam Preoperative Anxiety and Information Scale (APAIS) 3. Coping and Adaptation Processing Scale-Short Form (CAPS-SF) 4. Quality of Recovery -15 (QOR-15) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above
- Patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy) under general anesthesia
- ASA status I or II
- Able to read and understand the information sheet, the questionnaires, and the consent form.
Key exclusion criteria (3 listed)
- Unable to read and understand the information sheet, the questionnaires, and the consent form.
- Age above 80 years
- WIth severe medical or psychological diseases
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 |
|---|---|---|
| Quality of Recovery -15The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3. | Diagnostic test | Study group |
Primary outcome
Quality of Recovery -15 score at postoperative 72 hours
Time frame: at postoperative 72 hours
There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)
5 secondary outcomes
Quality of Recovery -15 score at postoperative 24 hours
Time frame: at postoperative 24 hours
Quality of Recovery -15 score at postoperative 48 hours
Time frame: at postoperative 48 hours
Postoperative pain score
Time frame: at postoperative 24, 48, and 72 hours
Length of stay
Time frame: through study completion, an average of 1 year
Postoperative nausea or vomiting
Time frame: at postoperative 24, 48, and 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 32703550Yoon S, Joo H, Oh YM, Lee J, Bahk JH, Lee HJ. Validation and clinical utility of the Korean version of the Quality of Recovery-15 with enhanced recovery after surgery: a prospective observational cohort study. Br J Anaesth. 2020 Oct;125(4):614-621. doi: 10.1016/j.bja.2020.06.040. Epub 2020 Jul 21.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
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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.
Hojin Lee, MD principal investigator
Seoul National University 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 Quality of Recovery -15 in people with Postoperative Complications and Anxiety, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Dec 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery -15 score at postoperative 72 hours (time frame: at postoperative 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599231, which also lists 2 linked publications.
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 7 Dec 2022.