Perioperative/Postoperative ComplicationsPhase 3NCT01613651
Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer
A Phase 3 study testing robot-assisted laparoscopic surgery, questionnaire administration and intraoperative complication management/prevention in people with Perioperative/Postoperative Complications and Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Perioperative/Postoperative Complications, Prostate Cancer
- What is being tested?
- robot-assisted laparoscopic surgery, questionnaire administration and intraoperative complication management/prevention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2012to 11 Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
- Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
- Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
Who cannot join
- Non-compliance
- Prior radiotherapy to the pelvis or prostate
- Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon
- Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
- Intra-operative injuries (for example: rectal injury)
- Inadequate hemostasis
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (RALP) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during RALP.
SECONDARY OBJECTIVES:
- To determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index [BMI], pathologic stage, Gleason sum, extent of lymph node dissection).
II. To report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain.
III. To compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during RALP.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo RALP.
ARM II: Patients undergo RALP and placement of pelvic drain.
After completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.
- Being tested
- robot-assisted laparoscopic surgery, questionnaire administration, intraoperative complication management/prevention
- Medical subject headings
- Postoperative Complications, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo RALP
questionnaire administrationOther
Ancillary studies
intraoperative complication management/preventionOther
Undergo placement of pelvic drain
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RALP) | Experimental | Patients undergo RALP. Receives: Procedure: robot-assisted laparoscopic surgery; Other: questionnaire administration |
| Arm II (RALP and placement of pelvic drain) | Experimental | Patients undergo RALP and placement of pelvic drain. Receives: Procedure: robot-assisted laparoscopic surgery; Other: questionnaire administration; Other: intraoperative complication management/prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates.
Measured: Within 90 days from prostatectomy
Secondary outcomes (3)
Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0
Further analysis will be conducted using multivariate logistic regression, to determine whether the odds of early postoperative adverse events are significantly different for patients in different study arms, once they have controlled for confounding prognostic factors, such as age, BMI, pathologic stage, Gleason sum, and lymph node dissection template. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.
Measured: Within 90 days post prostatectomy
Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency
Survival analysis will be used to determine if there is any significant difference between patients on two arms of the study with respect to time to continence or potency. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.
Measured: Up to 12 months
Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0
Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test.
Measured: Within 90 days from prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start24 Aug 2012
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Yamzon, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613651
- Sponsor's protocol ID
- 11113
- Other IDs
- NCI-2012-00558
- Status last verified
- Sep 2017
- First submitted
- 5 Jun 2012
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01613651
- Acronym / sponsor ID
- 11113
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Aug 2012 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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 randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (RALP) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during RALP.
SECONDARY OBJECTIVES:
- To determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index [BMI], pathologic stage, Gleason sum, extent of lymph node dissection).
II. To report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain.
III. To compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during RALP.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo RALP.
ARM II: Patients undergo RALP and placement of pelvic drain.
After completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (RALP) | Experimental | Procedure: robot-assisted laparoscopic surgery, Other: questionnaire administrationPatients undergo RALP. |
| Arm II (RALP and placement of pelvic drain) | Experimental | Procedure: robot-assisted laparoscopic surgery, Other: questionnaire administration, Other: intraoperative complication management/preventionPatients undergo RALP and placement of pelvic drain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center
- Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
- Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
Key exclusion criteria (6 listed)
- Non-compliance
- Prior radiotherapy to the pelvis or prostate
- Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon
- Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery
- Intra-operative injuries (for example: rectal injury)
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 |
|---|---|---|
| robot-assisted laparoscopic surgeryUndergo RALP | Procedure or surgery | Arm I (RALP), Arm II (RALP and placement of pelvic drain) |
| questionnaire administrationAncillary studies | Other | Arm I (RALP), Arm II (RALP and placement of pelvic drain) |
| intraoperative complication management/preventionUndergo placement of pelvic drain | Other | Arm II (RALP and placement of pelvic drain) |
Primary outcome
Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
Time frame: Within 90 days from prostatectomy
The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates.
3 secondary outcomes
Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0
Time frame: Within 90 days post prostatectomy
Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency
Time frame: Up to 12 months
Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0
Time frame: Within 90 days from prostatectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
Related trials for Perioperative/Postoperative Complications
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
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.
Jonathan Yamzon principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing robot-assisted laparoscopic surgery, questionnaire administration and intraoperative complication management/prevention in people with Perioperative/Postoperative Complications and Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Sep 2017. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0) (time frame: Within 90 days from prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.