Back to resultsTrial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Primary Purpose
Bladder Cancer, Laparoscopy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open radical cystectomy
Laparoscopic-assisted radical cystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
- Patients fit for surgery (ECOG Performance Status 0,1).
Exclusion Criteria:
- 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.
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open Radical Cystectomy
Laparoscopic-assisted radical cystectomy.
Arm Description
Standard open radical cystectomy.
Laparoscopic-assisted radical cystectomy.
Outcomes
Primary Outcome Measures
Operative time
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Blood loss
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Length of hospital stay
LOS as measured in days
Time to oral intake
Measured in days
Conversion rate
Rate of conversion from laparoscopy to open surgery
Re-admission rate.
Re-hospitalization requirement.
Opioid requirements.
Requirement, dose and duration of narcotic analgesia.
Visceral injury
Any organ injury encountered during the operation.
Urine leak
Leakage of urine from urinary enteric anastomosis
Wound dehiscence, infection.
Wound gaping, evisceration or infection.
Enteric fistula
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Sepsis
Infection triggering a systematic immune response
Venous thromboembolism
DVT or pulmonary embolism
Secondary Outcome Measures
pT stage
Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)
Lymph node retrieval
Number of lymph nodes retrieved by open versus laparoscopic approaches.
pN stage
Lymph node metastasis (positive or negative), and number of positive nodes if present.
Surgical margins
Positive margins or negative margins. Location of positive margins (Urethral, ureteric)
Histological grade
Low grade, intermediate grade or high grade
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838873
Brief Title
Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Official Title
Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Radical Cystectomy
Arm Type
Active Comparator
Arm Description
Standard open radical cystectomy.
Arm Title
Laparoscopic-assisted radical cystectomy.
Arm Type
Experimental
Arm Description
Laparoscopic-assisted radical cystectomy.
Intervention Type
Procedure
Intervention Name(s)
Open radical cystectomy
Intervention Description
Standard open radical cystectomy and urinary diversion
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic-assisted radical cystectomy
Intervention Description
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
Primary Outcome Measure Information:
Title
Operative time
Description
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
Time Frame
During surgery
Title
Blood loss
Description
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
Time Frame
During surgery
Title
Length of hospital stay
Description
LOS as measured in days
Time Frame
Immediate post-operative period.
Title
Time to oral intake
Description
Measured in days
Time Frame
Immediate post-operative period
Title
Conversion rate
Description
Rate of conversion from laparoscopy to open surgery
Time Frame
During surgery
Title
Re-admission rate.
Description
Re-hospitalization requirement.
Time Frame
Intra-operative to sixth months.
Title
Opioid requirements.
Description
Requirement, dose and duration of narcotic analgesia.
Time Frame
During surgery through first post-operative week.
Title
Visceral injury
Description
Any organ injury encountered during the operation.
Time Frame
During surgery
Title
Urine leak
Description
Leakage of urine from urinary enteric anastomosis
Time Frame
Up to 4 weeks
Title
Wound dehiscence, infection.
Description
Wound gaping, evisceration or infection.
Time Frame
Up to 4 weeks
Title
Enteric fistula
Description
Leakage of intestinal contents due to failure of entero-enteric anastomosis
Time Frame
Up to 4 weeks
Title
Sepsis
Description
Infection triggering a systematic immune response
Time Frame
Up to 4 weeks
Title
Venous thromboembolism
Description
DVT or pulmonary embolism
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
pT stage
Description
Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)
Time Frame
Within 10 days post surgery.
Title
Lymph node retrieval
Description
Number of lymph nodes retrieved by open versus laparoscopic approaches.
Time Frame
Within 10 days post surgery.
Title
pN stage
Description
Lymph node metastasis (positive or negative), and number of positive nodes if present.
Time Frame
Within 10 days post surgery.
Title
Surgical margins
Description
Positive margins or negative margins. Location of positive margins (Urethral, ureteric)
Time Frame
Within 10 days post surgery
Title
Histological grade
Description
Low grade, intermediate grade or high grade
Time Frame
Within 10 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
Patients fit for surgery (ECOG Performance Status 0,1).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Aboulkassem, M.D., Ph.D.
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
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