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Completed

NCT Number: NCT04838873

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Laparoscopy Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open radical cystectomy

Procedure

Standard open radical cystectomy and urinary diversion

Laparoscopic-assisted radical cystectomy

Procedure

Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion

Primary outcomes

  1. 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.

  2. 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.

  3. Length of hospital stay

    Time frame: Immediate post-operative period.

    LOS as measured in days

  4. Time to oral intake

    Time frame: Immediate post-operative period

    Measured in days

  5. Conversion rate

    Time frame: During surgery

    Rate of conversion from laparoscopy to open surgery

  6. Re-admission rate.

    Time frame: Intra-operative to sixth months.

    Re-hospitalization requirement.

  7. Opioid requirements.

    Time frame: During surgery through first post-operative week.

    Requirement, dose and duration of narcotic analgesia.

  8. Visceral injury

    Time frame: During surgery

    Any organ injury encountered during the operation.

  9. Urine leak

    Time frame: Up to 4 weeks

    Leakage of urine from urinary enteric anastomosis

  10. Wound dehiscence, infection.

    Time frame: Up to 4 weeks

    Wound gaping, evisceration or infection.

  11. Enteric fistula

    Time frame: Up to 4 weeks

    Leakage of intestinal contents due to failure of entero-enteric anastomosis

  12. Sepsis

    Time frame: Up to 4 weeks

    Infection triggering a systematic immune response

  13. Venous thromboembolism

    Time frame: Up to 2 months

    DVT or pulmonary embolism

Secondary outcomes

  1. pT stage

    Time frame: Within 10 days post surgery.

    Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)

  2. Lymph node retrieval

    Time frame: Within 10 days post surgery.

    Number of lymph nodes retrieved by open versus laparoscopic approaches.

  3. pN stage

    Time frame: Within 10 days post surgery.

    Lymph node metastasis (positive or negative), and number of positive nodes if present.

  4. Surgical margins

    Time frame: Within 10 days post surgery

    Positive margins or negative margins. Location of positive margins (Urethral, ureteric)

  5. Histological grade

    Time frame: Within 10 days post surgery

    Low grade, intermediate grade or high grade

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 9, 2021
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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