Clinical trial NCT06394219: A Comparative Study Between Anterior and Posterior Pyelotomy in Transperitoneal Laparoscopic Pyelolithotomy
Official title: Transperitoneal Laparoscopic Pyelolithotomy: Is the Posterior Pyelotomy Better Than the Anterior? (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Large Renal Stone
Keywords: Pyelotomy
Laparoscopic Pyelolithotomy,
pelvic stone
kidney stone
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Operative time
timeFrame: at the end of surgery in the operating room
measure: Days for oral intake
timeFrame: Up to one week after surgery
measure: Days of hospital stay
timeFrame: up to ten days after surgery
measure: Postoperative urine leak
timeFrame: up to three days after surgery
measure: stone-free status
timeFrame: Up to one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.