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

Not Applicable

Completed

• Conditions: Large Renal Stone
• Interventions: Procedure: modified transperitoneal laparoscopic pyelolithotomy; Procedure: traditional transperitoneal laparoscopic pyelolithotomy

• Registration Number: NCT06394219
• Lead Sponsor: Damascus University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-01-01
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior Pyelotomy	modified transperitoneal laparoscopic pyelolithotomy	Modified transperitoneal laparoscopic pyelolithotomy: Patients who were randomized to receive modified transperitoneal laparoscopic pyelolithotomy by applying posterior pyelotomy.
Anterior Pyelotomy	traditional transperitoneal laparoscopic pyelolithotomy	Traditional transperitoneal laparoscopic pyelolithotomy: Patients who were randomized to receive classic transperitoneal laparoscopic pyelolithotomy

Primary Outcome Measures

Name	Time	Method
Days for oral intake	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
Postoperative urine leak	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
Days of hospital stay	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
Operative time	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
stone-free status	Up to one week after surgery	postoperative radiological imaging demonstrating evidence of residual stones It will be measured in the Outcome by the ratio

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic