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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838873
• Other study ID #: SO1901-31004
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Laparoscopy
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Open radical cystectomy
Standard open radical cystectomy and urinary diversion
• Laparoscopic-assisted radical cystectomy
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.	During surgery
Primary	Blood loss	EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.	During surgery
Primary	Length of hospital stay	LOS as measured in days	Immediate post-operative period.
Primary	Time to oral intake	Measured in days	Immediate post-operative period
Primary	Conversion rate	Rate of conversion from laparoscopy to open surgery	During surgery
Primary	Re-admission rate.	Re-hospitalization requirement.	Intra-operative to sixth months.
Primary	Opioid requirements.	Requirement, dose and duration of narcotic analgesia.	During surgery through first post-operative week.
Primary	Visceral injury	Any organ injury encountered during the operation.	During surgery
Primary	Urine leak	Leakage of urine from urinary enteric anastomosis	Up to 4 weeks
Primary	Wound dehiscence, infection.	Wound gaping, evisceration or infection.	Up to 4 weeks
Primary	Enteric fistula	Leakage of intestinal contents due to failure of entero-enteric anastomosis	Up to 4 weeks
Primary	Sepsis	Infection triggering a systematic immune response	Up to 4 weeks
Primary	Venous thromboembolism	DVT or pulmonary embolism	Up to 2 months
Secondary	pT stage	Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)	Within 10 days post surgery.
Secondary	Lymph node retrieval	Number of lymph nodes retrieved by open versus laparoscopic approaches.	Within 10 days post surgery.
Secondary	pN stage	Lymph node metastasis (positive or negative), and number of positive nodes if present.	Within 10 days post surgery.
Secondary	Surgical margins	Positive margins or negative margins. Location of positive margins (Urethral, ureteric)	Within 10 days post surgery
Secondary	Histological grade	Low grade, intermediate grade or high grade	Within 10 days post surgery