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NCT Number: NCT06394219

A Comparative Study Between Anterior and Posterior Pyelotomy in Transperitoneal Laparoscopic Pyelolithotomy

Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications.

there are two methods for LPL surgery : Transperitoneal (TLP) and Retroperitoneal (RLP).

RLP associated with shorter mean time for oral intake, and mean hospital stay after surgery.

The surgical exposure in the transperitoneal route for LP is familiar to the majority of surgeons. Also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. This study introduces a modified technique that creates application of posterior pyelotomy in TLP to achieve the advantages of RLP

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Key information

Conditions

Large Renal Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University.

The study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery.

The patients will be randomly divided into two groups. The first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy.

The second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy.

The data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with large renal pelvic stone > 2 cm .
  • failure of minimally invasive approaches such as PCNL or ESWL
  • stones that were neither amenable to ESWL nor were ideally suitable for PCNL
  • Patient's preference for a quick one-stage procedure.
  • Negative urine culture

Exclusion criteria

  • Patients refusing study participation.
  • Contraindication to general anesthesia.
  • Contraindication to laparoscopic surgery.
  • Patients with an intrarenal pelvis.
  • Previous surgical on the same kidney.
  • Associated anatomical deformity.

Treatment and study plan

traditional transperitoneal laparoscopic pyelolithotomy

Procedure

Performing anterior Pyelotomy.

Other names: TLP

modified transperitoneal laparoscopic pyelolithotomy

Procedure

Performing posterior pyelotomy

Primary outcomes

  1. Operative time

    Time frame: at the end of surgery in the operating room

    the duration of the surgical procedure. It is measured by minutes, and calculated from establishing the pneumoperitoneum until the surgery is completed by suturing the skin.

    It will be measured in the outcome by the mean

  2. Days for oral intake

    Time frame: Up to one week after surgery

    the number of days to start introducing oral fluids and food after surgery with good acceptance, and without vomiting or flatulence.

    It will be measured in the outcome by the mean

  3. Days of hospital stay

    Time frame: up to ten days after surgery

    the number of days the patient stayed in the hospital after surgery. It will be measured in the outcome by the mean

  4. Postoperative urine leak

    Time frame: up to three days after surgery

    considered to be present when the drain contained >30 cc of urine the morning after surgery.

    It is measured by answering the question: Is there any urinary leakage, yes or no? It will be measured in the outcome by the ratio

  5. stone-free status

    Time frame: Up to one week after surgery

    postoperative radiological imaging demonstrating evidence of residual stones It will be measured in the Outcome by the ratio

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Transperitoneal Laparoscopic Pyelolithotomy: Is the Posterior Pyelotomy Better Than the Anterior? (A Randomized Controlled Clinical Trial)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
May 1, 2024

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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