Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer; Laparoscopy
• Intervention / Treatment: Procedure: Open radical cystectomy; Procedure: Laparoscopic-assisted radical cystectomy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open Radical Cystectomy; Standard open radical cystectomy.	Procedure: Open radical cystectomy; Standard open radical cystectomy and urinary diversion
Experimental: Laparoscopic-assisted radical cystectomy.	Procedure: Laparoscopic-assisted radical cystectomy; Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.	During surgery
Blood loss	EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.	During surgery
Length of hospital stay	LOS as measured in days	Immediate post-operative period.
Time to oral intake	Measured in days	Immediate post-operative period
Conversion rate	Rate of conversion from laparoscopy to open surgery	During surgery
Re-admission rate.	Re-hospitalization requirement.	Intra-operative to sixth months.
Opioid requirements.	Requirement, dose and duration of narcotic analgesia.	During surgery through first post-operative week.
Visceral injury	Any organ injury encountered during the operation.	During surgery
Urine leak	Leakage of urine from urinary enteric anastomosis	Up to 4 weeks
Wound dehiscence, infection.	Wound gaping, evisceration or infection.	Up to 4 weeks
Enteric fistula	Leakage of intestinal contents due to failure of entero-enteric anastomosis	Up to 4 weeks
Sepsis	Infection triggering a systematic immune response	Up to 4 weeks
Venous thromboembolism	DVT or pulmonary embolism	Up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pT stage	Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)	Within 10 days post surgery.
Lymph node retrieval	Number of lymph nodes retrieved by open versus laparoscopic approaches.	Within 10 days post surgery.
pN stage	Lymph node metastasis (positive or negative), and number of positive nodes if present.	Within 10 days post surgery.
Surgical margins	Positive margins or negative margins. Location of positive margins (Urethral, ureteric)	Within 10 days post surgery
Histological grade	Low grade, intermediate grade or high grade	Within 10 days post surgery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hatem Aboulkassem, M.D., Ph.D., National Cancer Institute, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: SO1901-31004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No