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

April 30, 2024 updated by: Damascus University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anterior Pyelotomy

Traditional transperitoneal laparoscopic pyelolithotomy:

Patients who were randomized to receive classic transperitoneal laparoscopic pyelolithotomy
Procedure: traditional transperitoneal laparoscopic pyelolithotomy
Performing anterior Pyelotomy.
Other Names:
  • TLP
Experimental: Posterior Pyelotomy

Modified transperitoneal laparoscopic pyelolithotomy:

Patients who were randomized to receive modified transperitoneal laparoscopic pyelolithotomy by applying posterior pyelotomy.
Procedure: modified transperitoneal laparoscopic pyelolithotomy
Performing posterior pyelotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of surgery in the operating room
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
Up to one week after surgery
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
up to ten days after surgery
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
up to three days after surgery
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
Up to one week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Posterior Pyelotomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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