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The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.
Postoperative urinary retention (POUR) complicates up to 30% of general abdominal operations. It results in patient discomfort, embarrassment, interference with therapies, and significant nursing burden. More importantly, urinary retention necessitates use of intermittent catheterization or placement of an indwelling urinary catheter, which exposes the patient to an increased risk of urinary tract infection (UTI), urethral injury, and potentially increased hospital length of stay and cost. For these reasons, a safe and effective intervention for preventing POUR would be highly valuable. Despite such a need, no contemporary studies exist evaluating medications that can be used to prevent POUR in broad general surgery populations. To address this gap, the investigators have designed a prospective, randomized, double-blind, placebo-controlled trial to test the hypothesis that preoperative loading with tamsulosin will prevent POUR in patients undergoing elective, inpatient complex intra-abdominal surgery and thereby lead to improved short-term outcomes.
Tamsulosin is a safe and widely-used selective alpha-1-A adrenergic blocker commonly used for the treatment of lower urinary tract symptoms in men with benign prostatic hypertrophy. It has also been shown to have some benefit in reducing POUR and need for catheterization in men undergoing inguinal hernia repair and other outpatient urologic procedures. This study is a randomized, double-blind, placebo-controlled trial in which patients scheduled for inpatient complex intra-abdominal surgery will be randomized to receive either tamsulosin or placebo for 7 days pre-operatively, and up to several days post-operatively, and then rates of POUR will be compared between the two groups (Aim 1). A retrospective analysis of the data will be used to identify risk factors for POUR and subgroups of patients that would derive the greatest benefit from preoperative tamsulosin (Aim 2). Furthermore, short-term outcomes, including rate of urinary tract infection (UTI) and hospital length of stay, will be compared between the tamsulosin and placebo groups (Aim 3).
Enrolled subjects will be randomized using a blocked, stratified randomization process to either tamsulosin or placebo. Stratification variables include gender, pelvic vs non-pelvic surgery, and International Prostate Symptom Score (IPSS) survey results (which is a measure of baseline lower urinary tract symptoms). After a 7-day treatment period, subjects will undergo surgery as scheduled, and then the assigned treatment will be continued for up to a total of 14 days until the subject either has return of normal voiding function, has required replacement of an indwelling urinary catheter, or is discharged from the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome | need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters | within 0-7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome | Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours | within 0-7 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evie H Carchman, MD | University of Wisconsin - Madison School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20927768 | Background | Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2. | |
| 23492981 | Background | Choi S, Awad I. Maintaining micturition in the perioperative period: strategies to avoid urinary retention. Curr Opin Anaesthesiol. 2013 Jun;26(3):361-7. doi: 10.1097/ACO.0b013e32835fc8ba. |
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Subjects were randomized within 1 month of their surgery date but >7 days prior to surgery. 7 participants were not randomized for the following reasons: 4 subjects self-withdraw prior to randomization; 3 subjects had surgery date moved up to within the 7-day window before surgery
Recruitment began in August 2015 and continued until Feb 2018. Subjects were recruited from surgery clinics at a single university hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| FG001 | Placebo | Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
76 subjects randomized to Tamsulosin; 4 surgery cancelled, 1 withdrew prior to starting study drug, 1 had intraoperative urethral injury precluding ability to collect outcome data, therefore analysis population was 70 subjects. 75 randomized to Placebo; 3 withdrew prior to starting study drug, 1 surgery cancelled, therefore analysis pop. was 71
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome | need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters | This is an intent-to-treat analysis, including all subjects who were randomized and did not withdraw prior to the intended start date of their study drug. | Posted | Count of Participants | Participants | within 0-7 days after surgery |
|
treatment day 1 (7 days before surgery) until 30 days after surgery
Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
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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 | Tamsulosin | Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred vision | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Evie Carchman, MD | University of Wisconsin - Madison | 608-263-2521 | carchman@surgery.wisc.edu |
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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 | Dec 8, 2017 | Apr 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D014552 | Urinary Tract Infections |
| D055499 | Catheter-Related Infections |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
|
| Placebo | Drug | Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
|
| Time Until First Spontaneous Void | time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void | within 0-7 days after surgery |
| Total Number of Intermittent Catheterizations Required Per Subject | total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol | within 0-7 days after surgery |
| First Post-void Residual Urine Volume | The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void | within 0-7 days after surgery |
| Discharge From Hospital With Indwelling Urinary Catheter | Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function. | up to 30 days after surgery |
| Urinary Tract Infection (UTI) | Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery | up to 30 days after surgery |
| Hospital Length of Stay in Days | Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital | up to 30 days after surgery |
| Number of Participants Who Experienced Adverse Events | Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting. | treatment day 1 (7 days before surgery) until 30 days after surgery |
| 24709715 | Background | Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Meddings J, Pegues DA, Pettis AM, Saint S, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 May;35(5):464-79. doi: 10.1086/675718. No abstract available. |
| 24042368 | Background | Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013 Sep 17;159(6):401-10. doi: 10.7326/0003-4819-159-6-201309170-00006. |
| 11750250 | Background | O'Leary MP. Tamsulosin: current clinical experience. Urology. 2001 Dec;58(6 Suppl 1):42-8; discussion 48. doi: 10.1016/s0090-4295(01)01346-2. |
| 24642148 | Background | Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05. |
| 9783935 | Background | Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6. |
| 9609623 | Background | Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5. |
| 17475584 | Background | Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9. |
| 20350754 | Background | Yaycioglu O, Altan-Yaycioglu R. Intraoperative floppy iris syndrome: facts for the urologist. Urology. 2010 Aug;76(2):272-6. doi: 10.1016/j.urology.2010.01.025. Epub 2010 Mar 28. |
| 17467530 | Background | Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011. |
| surgery cancelled |
|
| BG001 | Placebo | Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IPSS | IPSS is the International Prostate Symptom Score. This is a validated 7-question survey that characterizes severity of lower urinary tract symptoms. The score ranges from 0-35, with high scores indicating more significant symptoms (i.e. weak stream, urinary frequency, needing to strain to begin urination, etc). This is a self-completed survey filled out by the subject. | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Pelvic Surgery | "Pelvic Surgery" was defined as surgical procedure involving dissection/resection/anastomosis involving the rectum or pelvis. | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Epidural | This baseline characteristic describes whether or not an epidural was used for postoperative analgesia | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| ASA Class | American Society of Anesthesiologists (ASA) Classification characterizes baseline comorbidities of patients undergoing surgery: Class 1- normal healthy patient Class 2- Mild systemic disease Class 3- Severe systemic disease | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Body Mass Index | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| History of Prior Urinary Retention | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Smoker | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| COPD | Chronic Obstructive Pulmonary Disease (COPD) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Hypertension | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| CHF | Congestive heart failure (CHF) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Prior MI | Myocardial infarction (MI) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| BPH | Benign prostatic hyperplasia (BPH) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Prior CVA | Cerebrovascular accident (CVA) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| Diabetes | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| IBD | Inflammatory bowel disease (IBD) | These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects. | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. |
|
|
| Secondary | Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome | Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours | Posted | Count of Participants | Participants | within 0-7 days after surgery |
|
|
|
| Secondary | Time Until First Spontaneous Void | time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void | Time to first spontaneous void was not collected as this is not relevant clinically to diagnosis of urinary retention, and our bladder management protocol prevents unbiased collection of this data point. | Posted | within 0-7 days after surgery |
|
|
| Secondary | Total Number of Intermittent Catheterizations Required Per Subject | total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol | Posted | Count of Participants | Participants | within 0-7 days after surgery |
|
|
|
| Secondary | First Post-void Residual Urine Volume | The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void | Only includes subjects who were NOT straight-catheterized AND there were 20 additional subjects for which PVR was not recorded | Posted | Mean | Standard Deviation | mL | within 0-7 days after surgery |
|
|
|
| Secondary | Discharge From Hospital With Indwelling Urinary Catheter | Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function. | Posted | Count of Participants | Participants | up to 30 days after surgery |
|
|
|
| Secondary | Urinary Tract Infection (UTI) | Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery | This participant did not have urinary retention; self-reported UTI, catheter was removed on post operative day #2 | Posted | Count of Participants | Participants | up to 30 days after surgery |
|
|
|
| Secondary | Hospital Length of Stay in Days | Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital | Posted | Mean | Standard Deviation | days | up to 30 days after surgery |
|
|
|
| Secondary | Number of Participants Who Experienced Adverse Events | Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting. | Posted | Count of Participants | Participants | treatment day 1 (7 days before surgery) until 30 days after surgery |
|
|
|
| 1 |
| 76 |
| 3 |
| 76 |
| 10 |
| 76 |
| EG001 | Placebo | Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule:
| 0 | 75 | 5 | 75 | 8 | 75 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Systematic Assessment | supratherapeutic on Lovenox leading to spontaneous rectus sheath hematoma |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment | Bleeding requiring return to the operating room |
|
| Intra-abdominal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Death NOS | General disorders | Systematic Assessment | Subject had gastric cancer, died from advanced cancer |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment | Ileus/SBO |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | Systematic Assessment | Tingling sensation |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Systematic Assessment | Frequent urge to urinate |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Rhinitis infective | Infections and infestations | Systematic Assessment | Runny nose |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ASA Class 3 |
|
| greater than 2 catheterizations |
|