Bladder CancerNCT04838873
Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
A study testing Open radical cystectomy and Laparoscopic-assisted radical cystectomy in people with Bladder Cancer and Laparoscopy, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Bladder Cancer, Laparoscopy
- What is being tested?
- Open radical cystectomy and Laparoscopic-assisted radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
- Patients fit for surgery (ECOG Performance Status 0,1).
Who cannot join
- Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
- Patients with advanced hydronephrosis or renal failure.
- Patients refusing surgery.
- Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
- Patients with metastatic urinary bladder cancer.
- Patients who received prior pelvic radiotherapy.
- Patients refusing randomization and/or participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.
Read the detailed description
The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.
- Conditions
- Bladder Cancer, Laparoscopy
- Being tested
- Open radical cystectomy, Laparoscopic-assisted radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open radical cystectomyProcedure or surgery
Standard open radical cystectomy and urinary diversion
Laparoscopic-assisted radical cystectomyProcedure or surgery
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
| Study group | Role | What they receive |
|---|---|---|
| Open Radical Cystectomy | Active comparator | Standard open radical cystectomy. Receives: Procedure: Open radical cystectomy |
| Laparoscopic-assisted radical cystectomy. | Experimental | Laparoscopic-assisted radical cystectomy. Receives: Procedure: Laparoscopic-assisted radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Measured: During surgery
Blood loss
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Measured: During surgery
Length of hospital stay
LOS as measured in days
Measured: Immediate post-operative period.
Time to oral intake
Measured in days
Measured: Immediate post-operative period
Conversion rate
Rate of conversion from laparoscopy to open surgery
Measured: During surgery
Re-admission rate.
Re-hospitalization requirement.
Measured: Intra-operative to sixth months.
Opioid requirements.
Requirement, dose and duration of narcotic analgesia.
Measured: During surgery through first post-operative week.
Visceral injury
Any organ injury encountered during the operation.
Measured: During surgery
Urine leak
Leakage of urine from urinary enteric anastomosis
Measured: Up to 4 weeks
Wound dehiscence, infection.
Wound gaping, evisceration or infection.
Measured: Up to 4 weeks
Enteric fistula
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Measured: Up to 4 weeks
Sepsis
Infection triggering a systematic immune response
Measured: Up to 4 weeks
Venous thromboembolism
DVT or pulmonary embolism
Measured: Up to 2 months
Secondary outcomes (5)
pT stage
Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)
Measured: Within 10 days post surgery.
Lymph node retrieval
Number of lymph nodes retrieved by open versus laparoscopic approaches.
Measured: Within 10 days post surgery.
pN stage
Lymph node metastasis (positive or negative), and number of positive nodes if present.
Measured: Within 10 days post surgery.
Surgical margins
Positive margins or negative margins. Location of positive margins (Urethral, ureteric)
Measured: Within 10 days post surgery
Histological grade
Low grade, intermediate grade or high grade
Measured: Within 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start24 Jan 2019
- Primary completion1 Jul 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelbary Ali, Cairo University
- Investigators
- Hatem Aboulkassem, M.D., Ph.D., Principal investigator, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838873
- Sponsor's protocol ID
- SO1901-31004
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
- ClinicalTrials.gov ID
- NCT04838873
- Acronym / sponsor ID
- SO1901-31004
- Conditions
- Bladder Cancer, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.
Detailed description
The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Radical Cystectomy | Active comparator | Procedure: Open radical cystectomyStandard open radical cystectomy. |
| Laparoscopic-assisted radical cystectomy. | Experimental | Procedure: Laparoscopic-assisted radical cystectomyLaparoscopic-assisted radical cystectomy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
- Patients fit for surgery (ECOG Performance Status 0,1).
Key exclusion criteria (7 listed)
- Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
- Patients with advanced hydronephrosis or renal failure.
- Patients refusing surgery.
- Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
- Patients with metastatic urinary bladder cancer.
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 |
|---|---|---|
| Open radical cystectomyStandard open radical cystectomy and urinary diversion | Procedure or surgery | Open Radical Cystectomy |
| Laparoscopic-assisted radical cystectomyLaparoscopic-assisted radical cystectomy and extracorporeal urinary diversion | Procedure or surgery | Laparoscopic-assisted radical cystectomy. |
Primary outcome
Operative time
Time frame: During surgery
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Blood loss
Time frame: During surgery
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Length of hospital stay
Time frame: Immediate post-operative period.
LOS as measured in days
Time to oral intake
Time frame: Immediate post-operative period
Measured in days
Conversion rate
Time frame: During surgery
Rate of conversion from laparoscopy to open surgery
Re-admission rate.
Time frame: Intra-operative to sixth months.
Re-hospitalization requirement.
Opioid requirements.
Time frame: During surgery through first post-operative week.
Requirement, dose and duration of narcotic analgesia.
Visceral injury
Time frame: During surgery
Any organ injury encountered during the operation.
Urine leak
Time frame: Up to 4 weeks
Leakage of urine from urinary enteric anastomosis
Wound dehiscence, infection.
Time frame: Up to 4 weeks
Wound gaping, evisceration or infection.
Enteric fistula
Time frame: Up to 4 weeks
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Sepsis
Time frame: Up to 4 weeks
Infection triggering a systematic immune response
Venous thromboembolism
Time frame: Up to 2 months
DVT or pulmonary embolism
5 secondary outcomes
pT stage
Time frame: Within 10 days post surgery.
Lymph node retrieval
Time frame: Within 10 days post surgery.
pN stage
Time frame: Within 10 days post surgery.
Surgical margins
Time frame: Within 10 days post surgery
Histological grade
Time frame: Within 10 days post surgery
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 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem Aboulkassem, M.D., Ph.D. principal investigator
National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open radical cystectomy and Laparoscopic-assisted radical cystectomy in people with Bladder Cancer and Laparoscopy, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 7 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 9 Apr 2021. 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study 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?
Operative time (time frame: During surgery). The study lists 13 primary outcomes in all. 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 9 Apr 2021.