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

NCT ID: NCT06394219

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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

Conditions

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Large Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anterior Pyelotomy

Traditional transperitoneal laparoscopic pyelolithotomy:

Patients who were randomized to receive classic transperitoneal laparoscopic pyelolithotomy

Group Type EXPERIMENTAL

traditional transperitoneal laparoscopic pyelolithotomy

Intervention Type PROCEDURE

Performing anterior Pyelotomy.

Posterior Pyelotomy

Modified transperitoneal laparoscopic pyelolithotomy:

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

Group Type EXPERIMENTAL

modified transperitoneal laparoscopic pyelolithotomy

Intervention Type PROCEDURE

Performing posterior pyelotomy

Interventions

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traditional transperitoneal laparoscopic pyelolithotomy

Performing anterior Pyelotomy.

Intervention Type PROCEDURE

modified transperitoneal laparoscopic pyelolithotomy

Performing posterior pyelotomy

Intervention Type PROCEDURE

Other Intervention Names

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TLP

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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Soltani MH, Hossein Kashi A, Farshid S, Mantegy SJ, Valizadeh R. Transperitoneal Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for Treating the Patients with Staghorn Kidney Stones: A Randomized Clinical Trial. Urol J. 2021 Dec 20;19(1):28-33. doi: 10.22037/uj.v18i.6831.

Reference Type BACKGROUND
PMID: 34927230 (View on PubMed)

Bai Y, Tang Y, Deng L, Wang X, Yang Y, Wang J, Han P. Management of large renal stones: laparoscopic pyelolithotomy versus percutaneous nephrolithotomy. BMC Urol. 2017 Aug 31;17(1):75. doi: 10.1186/s12894-017-0266-7.

Reference Type BACKGROUND
PMID: 28859655 (View on PubMed)

Al-Hunayan A, Abdulhalim H, El-Bakry E, Hassabo M, Kehinde EO. Laparoscopic pyelolithotomy: is the retroperitoneal route a better approach? Int J Urol. 2009 Feb;16(2):181-6. doi: 10.1111/j.1442-2042.2008.02210.x. Epub 2008 Dec 2.

Reference Type BACKGROUND
PMID: 19183229 (View on PubMed)

Gaur DD, Agarwal DK, Purohit KC, Darshane AS. Retroperitoneal laparoscopic pyelolithotomy. J Urol. 1994 Apr;151(4):927-9. doi: 10.1016/s0022-5347(17)35124-8.

Reference Type BACKGROUND
PMID: 8126827 (View on PubMed)

Radfar MH, Dadpour M, Simforoosh N, Basiri A, Nouralizadeh A, Shakiba B, Valipour R, Zare A. Laparoscopic pyelolithotomy in patients with previous ipsilateral renal stone surgery. Urologia. 2021 Feb;88(1):41-45. doi: 10.1177/0391560319890993. Epub 2019 Dec 23.

Reference Type BACKGROUND
PMID: 31868562 (View on PubMed)

Wang X, Li S, Liu T, Guo Y, Yang Z. Laparoscopic pyelolithotomy compared to percutaneous nephrolithotomy as surgical management for large renal pelvic calculi: a meta-analysis. J Urol. 2013 Sep;190(3):888-93. doi: 10.1016/j.juro.2013.02.092. Epub 2013 Feb 27.

Reference Type BACKGROUND
PMID: 23454154 (View on PubMed)

Other Identifiers

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Posterior Pyelotomy

Identifier Type: -

Identifier Source: org_study_id

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