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

Not Applicable

Completed

• Conditions: Laparoscopy; Bladder Cancer
• Interventions: Procedure: Open radical cystectomy; Procedure: Laparoscopic-assisted radical cystectomy

• Registration Number: NCT04838873
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-01-24
• Primary Completion: 2019-07-01
• Study Completion: 2020-12-30
• Study First Submitted: 2021-03-30
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Radical Cystectomy	Open radical cystectomy	Standard open radical cystectomy.
Laparoscopic-assisted radical cystectomy.	Laparoscopic-assisted radical cystectomy	Laparoscopic-assisted radical cystectomy.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt