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| Name | Class |
|---|---|
| Society of American Gastrointestinal and Endoscopic Surgeons | OTHER |
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North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.
This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid analgesia | Experimental |
| |
| Opioid-free analgesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid analgesics | Drug | Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Screened Participants Who Were Eligible to Participate in the Study | At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized. | 4 months |
| Percentage of Surgeons Agreeing and Adhering to Patient Randomization | At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds). | 4 months |
| Percentage of Eligible Patients Agreeing to Participate | At least 50% of eligible patients agree to participate in the study and are randomized. | 4 months |
| Percentage of Randomized Patients Complying With Allocated Treatment | At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed). | 4 months |
| Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment | At least 80% of the randomized patients complete outcome assessment at 30 days after surgery. | 4 months |
| Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments | Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%. | 4 months |
| Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes. | 30 days. |
| Time to Stopping Pain Medication |
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Inclusion Criteria:
Adult patients (>18 yo) undergoing outpatient surgery
Exclusion Criteria:
All patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35849399 | Derived | Do U, El-Kefraoui C, Pook M, Balvardi S, Barone N, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF Jr; McGill Better Opioid Prescribing Collaboration; Alhashemi M, Antoun A, Barkun JS, Brecht KM, Chaudhury PK, Deckelbaum D, Di Lena E, Dumitra S, Elhaj H, Fata P, Fleiszer D, Fried GM, Grushka J, Kaneva P, Khwaja K, Lapointe-Gagner M, McKendy KM, Meguerditchian AN, Meterissian SH, Montgomery H, Rajabiyazdi F, Safa N, Touma N, Tremblay F. Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221430. doi: 10.1001/jamanetworkopen.2022.21430. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid Analgesia | Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| FG001 | Opioid-free Analgesia | Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Opioid Analgesia | Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Screened Participants Who Were Eligible to Participate in the Study | At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized. | Posted | Count of Participants | Participants | 4 months |
|
|
The adverse events data were collected up to 30 days after surgery.
Opioid side effects were identified by using the Perioperative Opioid-Related Symptom Distress Scale. Also, data regarding adverse drug events was obtained from spontaneous patient reporting and from data reported by clinicians in electronic medical records. Two independent clinicians coded adverse event data using the MedDRA coding dictionary. Disagreements regarding coding were resolved by consensus.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid Analgesia | Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Haematoma | Surgical and medical procedures | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio F. Fiore Jr | McGill University | 514 934-1934 | 35655 | julio.fiorejunior@mcgill.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2022 | Sep 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| D018712 | Analgesics, Non-Narcotic |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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This study will be a parallel, two-group, assessor-blind, pilot randomized trial.
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Patient-reported outcomes and treatment adherence data will be collected via self-administered electronic questionnaires distributed using REDCap (http://project-redcap.org/) and completed by patients via smartphone, tablet or personal computer. Electronic outcome data will be transmitted directly to the REDCap database and verified by a blinded assessor. Adherence data will be verified by unblinded study staff. Patients who are not computer savvy, have limited access or prefer non-electronic assessment will complete the questionnaires via telephone interviews with a blinded assessor; in this case, data will be recorded in paper forms and subsequently transferred to the REDCap database. Outcome data that are not patient-reported (e.g. postoperative complications, unplanned healthcare utilization, chronic opioid use), will be obtained from medical records by a blinded assessor.
|
| Non-opioid analgesics | Drug | Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
|
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items). |
| 4 months |
The time to the first report of stopping the use of pain medication. |
| 30 days. |
| Postoperative Health Status | Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured. | Weeks 1, 2, 3 and 4 after surgery. |
| Opioid Side-effects | Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. The reported rates indicate the number of reported events per period of evaluation. | Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery |
| Rate of Opioid Misuse | Measured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to >1 question indicates the patient exhibits prescription opioid misuse. | 4 weeks |
| Postoperative Complications Classification | Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse). Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic | 30 days. |
| Rate of Unplanned Healthcare Utilization | Emergency department visits, hospital readmissions. | 30 days. |
| Rate of Adverse Drug Events | Obtained from spontaneous patient reporting (Trigger question "Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?"). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system. | 30 days after surgery |
| Rate of Prolonged Opioid Use | Filling of opioid prescriptions up to 3 months after surgery. | 3 months |
| Comprehensive Complication Index at 30-day | Measured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications. | 30 days |
| BG001 | Opioid-free Analgesia | Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| BMI >= 30.0 | Count of Participants | Participants |
|
| American Society of Anesthesiology score I | Classified based on the ASA classification chart: ASA I Definition - A person in good health. (e.g., a person who doesn't smoke tobacco products and minimally uses alcohol.) | Count of Participants | Participants |
|
| American Society of Anesthesiology score II | Classified based on the ASA classification chart: ASA II Definition -A mild but well-managed or treated condition. (e.g., a person who is pregnant, has a mild lung condition, may smoke tobacco products or drinks alcohol socially or has overweight.) | Count of Participants | Participants |
|
| American Society of Anesthesiology score III | Classified based on the ASA classification chart: ASA III Definition - A serious condition that has an impact on a person's overall health. (e.g., A person who has a BMI greater than 40, alcohol use disorder or an implanted pacemaker.) | Count of Participants | Participants |
|
| Risk of opioid abuse score (SD) | Potential for opioid misuse was assessed by the Screener and Opioid Assessment for Patients With Pain Short Form (5-item) questionnaire. The total score ranges from 0 to 20 and a score ≥ 4 indicates a likely high risk of opioid misuse after prescription. | Mean | Standard Deviation | units on a scale |
|
| Risk of opioid abuse score ≥4 | Potential for opioid misuse was assessed by the Screener and Opioid Assessment for Patients With Pain Short Form (5-item) questionnaire. The total score ranges from 0 to 20 and a score ≥ 4 indicates a likely high risk of opioid misuse after prescription. | Count of Participants | Participants |
|
| Pain catastrophizing score, mean (SD) | This 13-item questionnaire (5-point scale, 0= "not at all", 4= "all the time") aims to quantify an individual's tendency to magnify the threat value of pain and to feel helpless in its presence. Scoring algorithms provide a total pain catastrophizing score (range 0-52, best-worst), as well as subscale scores (rumination, magnification and helplessness). | Mean | Standard Deviation | units on a scale |
|
| Employed, including self-employed | Count of Participants | Participants |
|
| Retired | Count of Participants | Participants |
|
| Homemaker | Count of Participants | Participants |
|
| Student | Count of Participants | Participants |
|
| Unemployed | Count of Participants | Participants |
|
| Unable to work, receiving disability pension | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Prerandomization treatment group preference: Unsure or no preference | Count of Participants | Participants |
|
| Prerandomization treatment group preference: Opioid medication group | Count of Participants | Participants |
|
| Prerandomization treatment group preference: Opioid-free medication group | Count of Participants | Participants |
|
| Prerandomization perceptions of opioid-free analgesia: Very Effective | Count of Participants | Participants |
|
| Prerandomization perceptions of opioid-free analgesia: Somewhat Effective | Count of Participants | Participants |
|
| Prerandomization perceptions of opioid-free analgesia: Not effective | Count of Participants | Participants |
|
| Prerandomization perceptions of opioid-free analgesia: No specific expectation | Count of Participants | Participants |
|
| Abdominal Surgery | Count of Participants | Participants |
|
| Laparoscopic appendectomy | Count of Participants | Participants |
|
| Laparoscopic cholecystectomy | Count of Participants | Participants |
|
| Laparoscopic inguinal hernia repair | Count of Participants | Participants |
|
| Open inguinal hernia repair | Count of Participants | Participants |
|
| Open umbilical hernia repair | Count of Participants | Participants |
|
| Open incisional hernia repair | Count of Participants | Participants |
|
| Breast surgery | Count of Participants | Participants |
|
| Partial mastectomy | Count of Participants | Participants |
|
| Partial mastectomy with sentinel node biopsy | Count of Participants | Participants |
|
| Partial mastectomy with axillary node dissection | Count of Participants | Participants |
|
| Partial mastectomy with sentinel node biopsy and reconstruction | Count of Participants | Participants |
|
| Total mastectomy with sentinel node biopsy | Count of Participants | Participants |
|
| Total mastectomy with sentinel node biopsy and reconstruction | Count of Participants | Participants |
|
| Total mastectomy with axillary node dissection and reconstruction | Count of Participants | Participants |
|
| Received intraoperative regional analgesia | Count of Participants | Participants |
|
| Peripheral nerve block | Count of Participants | Participants |
|
| Wound infiltration | Count of Participants | Participants |
|
| Duration of surgery | Mean | Standard Deviation | min |
|
| Amount of opioids received in the PACU | Mean | Standard Deviation | MME |
|
|
| Primary | Percentage of Surgeons Agreeing and Adhering to Patient Randomization | At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds). | *Providers were not considered as enrolled participants but did contribute to this assessment. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Primary | Percentage of Eligible Patients Agreeing to Participate | At least 50% of eligible patients agree to participate in the study and are randomized. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Primary | Percentage of Randomized Patients Complying With Allocated Treatment | At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed). | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Primary | Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment | At least 80% of the randomized patients complete outcome assessment at 30 days after surgery. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Primary | Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments | Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%. | As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample. | Posted | Count of Units | Questionnaires | 4 months | Questionnaires | Questionnaires |
|
|
|
| Primary | Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments | Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items). | As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample. | Posted | Count of Units | Questionnaire Items | 4 months | Questionnaire Items | Questionnaire Items |
|
|
|
| Secondary | Postoperative Pain | Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes. | Posted | Mean | Standard Deviation | score on a scale | 30 days. |
|
|
|
| Secondary | Time to Stopping Pain Medication | The time to the first report of stopping the use of pain medication. | Posted | Mean | Standard Deviation | days postoperative | 30 days. |
|
|
|
| Secondary | Postoperative Health Status | Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured. | Posted | Mean | Standard Deviation | T-score | Weeks 1, 2, 3 and 4 after surgery. |
|
|
|
| Secondary | Opioid Side-effects | Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. The reported rates indicate the number of reported events per period of evaluation. | Posted | Number | Number of reported events | Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery |
|
|
|
| Secondary | Rate of Opioid Misuse | Measured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to >1 question indicates the patient exhibits prescription opioid misuse. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Postoperative Complications Classification | Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse). Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic | Posted | Count of Participants | Participants | 30 days. |
|
|
|
| Secondary | Rate of Unplanned Healthcare Utilization | Emergency department visits, hospital readmissions. | Posted | Count of Participants | Participants | 30 days. |
|
|
|
| Secondary | Rate of Adverse Drug Events | Obtained from spontaneous patient reporting (Trigger question "Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?"). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system. | Posted | Count of Participants | Participants | 30 days after surgery |
|
|
|
| Secondary | Rate of Prolonged Opioid Use | Filling of opioid prescriptions up to 3 months after surgery. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Comprehensive Complication Index at 30-day | Measured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
|
|
| 0 |
| 39 |
| 1 |
| 39 |
| 14 |
| 39 |
| EG001 | Opioid-free Analgesia | Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. | 0 | 37 | 1 | 37 | 16 | 37 |
| Seroma | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Abdominal distention | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Postoperative wound infection | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment | A clinically meaningful event as per the Perioperative Opioid-Related Symptom Distress Scale description. |
|
| Itching | General disorders | Systematic Assessment | A clinically meaningful event as per the Perioperative Opioid-Related Symptom Distress Scale description. |
|
| Fatigue | General disorders | Systematic Assessment | A clinically meaningful event as per the Perioperative Opioid-Related Symptom Distress Scale description. |
|
| Inability to concentrate | General disorders | Systematic Assessment | A clinically meaningful event as per the Perioperative Opioid-Related Symptom Distress Scale description. |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| POD2 Severity Scale score |
|
| POD3 Severity Scale score |
|
| POD4 Severity Scale score |
|
| POD5 Severity Scale score |
|
| POD6 Severity Scale score |
|
| POD7 Severity Scale score |
|
| Post Operative Week (POW) 2 Severity Scale score |
|
| POW3 Severity Scale score |
|
| POW4 Severity Scale score |
|
| Baseline Interference Scale score |
|
| POD 1 Interference Scale score |
|
| POD 2 Interference Scale score |
|
| POD 3 Interference Scale score |
|
| POD 4 Interference Scale score |
|
| POD 5 Interference Scale score |
|
| POD 6 Interference Scale score |
|
| POD 7 Interference Scale score |
|
| POW 2 Interference Scale score |
|
| POW 3 Interference Scale score |
|
| POW 4 Interference Scale score |
|
| Physical functioning POW 2 |
|
| Physical functioning POW 3 |
|
| Physical functioning POW 4 |
|
| Social participation Baseline |
|
| Social participation POW 1 |
|
| Social participation POW 2 |
|
| Social participation POW 3 |
|
| Social participation POW 4 |
|
| Anxiety Baseline |
|
| Anxiety POW 1 |
|
| Anxiety POW 2 |
|
| Anxiety POW 3 |
|
| Anxiety POW 4 |
|
| Depression Baseline |
|
| Depression POW 1 |
|
| Depression POW 2 |
|
| Depression POW 3 |
|
| Depression POW 4 |
|
| Pain interference Baseline |
|
| Pain interference POW 1 |
|
| Pain interference POW 2 |
|
| POW 3 |
|
| POW 4 |
|
| Sleep disturbance Baseline |
|
| Sleep disturbance POW 1 |
|
| Sleep disturbance POW 2 |
|
| Sleep disturbance POW 3 |
|
| Sleep disturbance POW 4 |
|
| Fatigue Baseline |
|
| Fatigue POW 1 |
|
| Fatigue POW 2 |
|
| Fatigue POW 3 |
|
| Fatigue POW 4 |
|
| Constipation : 30-day rate (any event) |
|
| Constipation : 30-day rate (clinically meaningful event) |
|
| Nausa : 7-day rate (any event) |
|
| Nausa : 7-day rate (clinically meaningful event) |
|
| Nausa : 30-day rate (any event) |
|
| Nausa : 30-day rate (clinically meaningful event) |
|
| Vomiting : 7-day rate (any event) |
|
| Vomiting : 7-day rate (clinically meaningful event) |
|
| Vomiting : 30-day rate (any event) |
|
| Vomiting : 30-day rate (clinically meaningful event) |
|
| Itching : 7-day rate (any event) |
|
| Itching : 7-day rate (clinically meaningful event) |
|
| Itching : 30-day rate (any event) |
|
| Itching : 30-day rate (clinically meaningful event) |
|
| Fatigue : 7-day rate (any event) |
|
| Fatigue : 7-day rate (clinically meaningful event) |
|
| Fatigue : 30-day rate (any event) |
|
| Fatigue : 30-day rate (clinically meaningful event) |
|
| Drowsiness : 7-day rate (any event) |
|
| Drowsiness : 7-day rate (clinically meaningful event) |
|
| Drowsiness : 30-day rate (any event) |
|
| Drowsiness : 30-day rate (clinically meaningful event) |
|
| Dizziness : 7-day rate (any event) |
|
| Dizziness : 7-day rate (clinically meaningful event) |
|
| Dizziness : 30-day rate (any event) |
|
| Dizziness : 30-day rate (clinically meaningful event) |
|
| Inability to concentrate : 7-day rate (any event) |
|
| Inability to concentrate : 7-day rate (clinically meaningful event) |
|
| Inability to concentrate : 30-day rate (any event) |
|
| Inability to concentrate : 30-day rate (clinically meaningful event) |
|
| Difficulty with urination : 7-day rate (any event) |
|
| Difficulty with urination : 7-day rate (clinically meaningful event) |
|
| Difficulty with urination : 30-day rate (any event) |
|
| Difficulty with urination : 30-day rate (clinically meaningful event) |
|
| Confusion : 7-day rate (any event) |
|
| Confusion : 7-day rate (clinically meaningful event) |
|
| Confusion : 30-day rate (any event) |
|
| Confusion : 30-day rate (clinically meaningful event) |
|
| IIIa/b |
|
| Readmission |
|
| Outpatient clinic visit |
|
| Diarrhea |
|
| Postoperative wound infection |
|
| Cough |
|
| Urinary retention |
|
| Hypertention |
|
| Tachycardia |
|
| Breast haematoma |
|
| Productive cough |
|
| Dyspepsia |
|
| Ecchymosis |
|
| Hypoesthesia |
|
| Neuralgia |
|
| Oropharyngeal pain |
|
| Penile swelling |
|
| Testicular swelling |
|
| Seroma |
|
| Urinary tract infection |
|
| Cystitis |
|
| Peripheral neuropathy |
|
| POW 3 |
|
| POW 4 |
|
| POM 2 |
|
| POM 3 |
|