Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).
The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. In the era of multimodal recovery algorithms emphasizing early diet advancement, ambulation, and shorter hospital length of stay, unnecessarily prolonging catheterization may interfere with many of these objectives. An indwelling urinary catheter interferes with early patient mobilization potentially lengthening hospitalization and subjects patients to an increased risk of urinary tract infection. A study of 2,355 consecutive patients undergoing primary colorectal cancer resection via laparotomy found an overall prevalence of postoperative urinary retention of 5.5%, however, those patients undergoing low pelvic surgery experience an almost 16% incidence in urinary retention.
Postoperative urinary catheter drainage after infraperitoneal colorectal surgery is commonly practiced, assuming some degree of nerve damage to the superior hypogastric plexus at the sacral promontory or of the nervi erigentes at the pelvic side wall resulting from pelvic dissection, causing transient or permanent dysfunction of the lower urinary tract. It has been believed that this intraoperative damage to the pelvic autonomic nerves may be associated with early postoperative acute urinary retention, and justifies an indwelling urinary catheter for several days following infraperitoneal pelvic surgery. However, there is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days.
Prolonged indwelling urinary catheter has been associated with increased risk of urinary tract infections, with the risk of bacteriuria between 3 and 10% per day when catheterized, with the risk of urinary tract infection increasing by 5% to 10% per catheter day after the second day of catheterization. The incidence of urinary tract infections after anorectal surgery and 5 days of catheterization has been shown to range between 42% and 60%. Higher mortality rates have been reported in hospitalized patients who developed urinary tract infection after indwelling catheterization with the incidence of bacteremia after single catheterization reported to be as high as 8%.
The optimal duration of urinary drainage after infraperitoneal colorectal surgery is unknown. Based on the autonomic mechanisms of micturition in relation to the striated muscle fibers of the external urethral sphincter, alpha blockade has been studied as a potential intervention to reduce the incidence of re-catheterization. A large Cochrane Database reviewed their role in five randomized trials, with four trials favoring alpha blockade over placebo. Furthermore, the side-effect profile of alpha-blockade was low and compared favorably to placebo.
Prior studies have suggested urinary bladder catheter drainage removed on postoperative day one following pelvic surgery may be safe and decrease the incidence of urinary tract infection. However, the study was underpowered to detect meaningful conclusions. A larger study investigating the optimal duration of urinary drainage concluded that removing the catheter one day postoperatively in patients undergoing infraperitoneal colorectal surgery is appropriate, unless a low rectal carcinoma is present or lymph node metastatic disease is present. The investigators wish to further substantiate this evidence and introduce the positive findings associated with alpha-blockade in minimizing the need for re-catheterization.
The investigators therefore propose a prospective, controlled randomized trial to compare the effects of 1 day's transurethral catheterization after infraperitoneal surgery with an alpha blockade medication compared to those of 3 days of catheterization, with acute urinary retention as a primary endpoint.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 hour postop catheter removal | Experimental | group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) |
|
| 72 hour postoperative catheter removal | No Intervention | catheter removed on postoperative day 3 (72 hours postoperatively) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazosin given 6 hours prior to catheter removal in the 24 hour group | Drug | Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Urinary Retention | Acute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine. | Postoperative day 1 or postpoperative 3 depending on group randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Symptomatic Urinary Tract Infection | Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection. | During 1 week of hospitalization (prior to discharge) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
After randomization:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Phillip Fleshner, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34184246 | Derived | Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4. | |
| 30192326 | Derived | Patel DN, Felder SI, Luu M, Daskivich TJ, N Zaghiyan K, Fleshner P. Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial. Dis Colon Rectum. 2018 Oct;61(10):1180-1186. doi: 10.1097/DCR.0000000000001206. |
Not provided
Not provided
5 subjects were excluded.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 24 Hour Postop Catheter Removal | group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively) |
| FG001 | 72 Hour Postoperative Catheter Removal | catheter removed on postoperative day 3 (72 hours postoperatively) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 24 Hour Postop Catheter Removal | group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively) |
| BG001 |
| 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 | Number of Participants With Acute Urinary Retention | Acute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine. | Posted | Count of Participants | Participants | Postoperative day 1 or postpoperative 3 depending on group randomization |
|
72 hours
Methods did not differ from definitions provided by clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 24 Hour Postop Catheter Removal | group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phillip Fleshner | Cedars Sinai Medical Center | (310) 289-9224 | Phillip.Fleshner@cshs.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2012 | Jun 21, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2012 | Oct 26, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D044382 | Population Groups |
| D011224 | Prazosin |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 72 Hour Postoperative Catheter Removal |
catheter removed on postoperative day 3 (72 hours postoperatively) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists Physical Status Classification | ASA I A normal healthy patient ASA II A patient with mild systemic disease Mild diseases only without substantive functional limitations. ASA III A patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases. ASA IV A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Surgery Indication | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Surgical drain | Count of Participants | Participants |
|
| intraoperative intravenous fluids | This is crystalloids received via intravenous access during surgery | Mean | Standard Deviation | milliliters |
|
| intraoperative estimated blood loss | A clinical estimate of surgical blood loss determined by the lead surgeon and anesthesiologist after the conclusion of the case. | Mean | Standard Deviation | milliliters |
|
| OR time | Mean | Standard Deviation | minutes |
|
| peri-operative blood transfusion | Count of Participants | Participants |
|
| Total mesorectal excision | Total mesorectal excision (TME) employs a precise, sharp dissection between the visceral and parietal layers of the endopelvic fascia to ensure en bloc removal of the perirectal areolar tissue, including the lateral and circumferential margins of the mesorectal envelope, lymphatics, and vascular/perineural tumor deposits with the primary rectal cancer. TME also preserves the autonomic nerves and reduces the risk of presacral bleeding. | Count of Participants | Participants |
|
| neoadjuvant chemotherapy | Count of Participants | Participants |
|
| intravenous pain medications on post-operative day one | in the immediate 24 hours following surgery, the total amount of intravenous narcotics consumed by the patient was recorded and collected. All intravenous narcotics were converted into equivalent milligrams of hydromorphone. | Mean | Standard Deviation | milligrams of hydromorphone |
|
| mean pain score | This is a 1-10 scale Pain 0: No pain at all, you feel perfectly normal. Pain 1: Very light barely noticeable pain Pain 2: Minor pain, Discomforting Pain 3: Tolerable pain Pain 4: Distressing, Strong, deep pain Pain 5: Very Distressing, Strong, deep, piercing pain Pain 6: Intense Pain deep, piercing pain so strong it seems to partially dominate your senses Pain 7: Very Intense Pain Pain 8: Horrible Pain: so intense you can no longer think clearly at all Pain 9: Excruciating, so intense you cannot tolerate Pain 10: Unimaginable Pain, so intense you will go unconscious shortly. | Mean | Standard Deviation | units on a scale |
|
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer | This is a staging system from stage 0 (best, no tumor) to stage 4 (worst, metastatic disease). T = tumor stage (T1 is best and invades submucosa, T2 invades muscularis, T3 invades pericolorectal tissues, T4 is worst and adherent to other organs N = nodal stage (N0 negative nodes is best, N+ positive nodes is worse) M = metastases stage (M0 no metastases is best, M+ metastases is worse) The categories are: 0: T0, N0, M0
| Count of Participants | Participants |
|
catheter removed on postoperative day 3 (72 hours postoperatively)
|
|
| Secondary | Number of Participants With a Symptomatic Urinary Tract Infection | Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection. | Posted | Count of Participants | Participants | During 1 week of hospitalization (prior to discharge) |
|
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 6 |
| 71 |
| EG001 | 72 Hour Postoperative Catheter Removal | catheter removed on postoperative day 3 (72 hours postoperatively) | 0 | 71 | 0 | 71 | 0 | 71 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |