OpenNCT06572371
Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
A study testing Laparoscopic pyeloplasty and Open pyeloplasty in people with Open and Laparoscopic, run by Tanta University at 1 site in Egypt.
Trial summary
To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open, Laparoscopic, Dismembered Pyeloplasty
- What is being tested?
- Laparoscopic pyeloplasty and Open pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as
- Symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension.
- Breakthrough urinary tract infections while on prophylactic antibiotics.
- Increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound.
- Low or decreasing differential renal function, but above 10%.
Who cannot join
- Patients having poor ipsilateral renal function < 10%.
- Patients with previous pelvi-ureteric junction obstruction repair.
- Associated renal stones.
- Patients unfit for surgery according to American Society of Anesthesiologists classification.
- Contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities…).
- Pediatric patients.
Show all 12Show fewer
- Pregnant women.
- Vesicoureteral reflux.
- Congenital renal anomalies as (horse- shoe kidney, pelvic kidney, mal- rotated kidney ...).
- Single functioning kidney.
- Malignancy.
- Refusal of written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study Comparing Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.
Read the detailed description
Pelvi-ureteric junction obstruction (PUJO) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter.
Open pyeloplasty (OP) has been the gold standard for PUJO repair since the first successful reconstruction of an obstructed PUJO was accomplished in 1892, and achieves success rates exceeding 90%.
Various open surgical techniques have been described based on the cause, location, and length of the PUJO. The most popular repair is the Anderson-Hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment.
Now, Laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open Anderson- Hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. It is also better than endopylotomy as it deals effectively with the crossing vessel
- Being tested
- Laparoscopic pyeloplasty, Open pyeloplasty
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic pyeloplastyProcedure or surgery
The first trocar was inserted under vision through the same supraumbilical incision and the intraperitoneal cavity was inspected The second 5 mm trocar was placed in the midclavicular line 2 inches below the costal margin. The third 10 mm trocar was placed lateral to the rectus muscle at the level of the anterior superior iliac spine. In right-sided pyeloplasty, a fourth trocar was inserted below the xiphistemum for liver retraction. Incision of the line of Toldt and mobilization of the colon was the first step of the transperitoneal approach. A 4/0 polysorbe stay suture was taken in the lateral aspect of the ureter distal to uretero-pelvic junction obstruction to identify the correct orientation after dismembering the ureter. A full thickness anastomosis was started from the angle of V shape spatulation to the lower pole of the renal pelvis.
Open pyeloplastyProcedure or surgery
A flank incision with the patient in lateral position was undertaken in open pyeloplasty. After accessing the retro- peritoneum, the ureter was identified and traced cranially till the PUJ segment.
Traction sutures was placed on the renal pelvis followed by excision of the narrowing segment. The ureter was spatulated by approximately 2 cm and a reduction pyeloplasty was performed, where necessary. Anastomosis was undertaken using vicryl 4-0 sutures. The primary anastomotic site was sutured in interrupted fashion followed by a continuous running suture of the posterior wall. Next, antegrade DJ stenting was performed and the anterior wall was anastomosed. After haemostatic control a 22 Fr drain was placed in the surgical bed.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic pyeloplasty | Experimental | Patients underwent laparoscopic pyeloplasty. Receives: Procedure: Laparoscopic pyeloplasty |
| Open pyeloplasty | Active comparator | Patients underwent open pyeloplasty. Receives: Procedure: Open pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
Amount of blood loss was recorded.
Measured: Intraoperatively
Secondary outcomes (2)
Etiology of obstruction
Etiology of obstruction such as adynamic segment, crossing vessel, stenotic segment, adhesions, and abnormal gonadal vein were recorded.
Measured: Intraoperatively
Complications
Complications was recorded such as wound complications, loin or abdominal pain, fever, chills and rigor, change of color of urine, dysuria.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OpenStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Soliman Messiha Georgy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572371
- Sponsor's protocol ID
- 36133/12/22
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
- ClinicalTrials.gov ID
- NCT06572371
- Acronym / sponsor ID
- 36133/12/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.
Detailed description
Pelvi-ureteric junction obstruction (PUJO) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter.
Open pyeloplasty (OP) has been the gold standard for PUJO repair since the first successful reconstruction of an obstructed PUJO was accomplished in 1892, and achieves success rates exceeding 90%.
Various open surgical techniques have been described based on the cause, location, and length of the PUJO. The most popular repair is the Anderson-Hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment.
Now, Laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open Anderson- Hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. It is also better than endopylotomy as it deals effectively with the crossing vessel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic pyeloplasty | Experimental | Procedure: Laparoscopic pyeloplastyPatients underwent laparoscopic pyeloplasty. |
| Open pyeloplasty | Active comparator | Procedure: Open pyeloplastyPatients underwent open pyeloplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as
- Symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension.
- Breakthrough urinary tract infections while on prophylactic antibiotics.
- Increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound.
- Low or decreasing differential renal function, but above 10%.
Key exclusion criteria (12 listed)
- Patients having poor ipsilateral renal function < 10%.
- Patients with previous pelvi-ureteric junction obstruction repair.
- Associated renal stones.
- Patients unfit for surgery according to American Society of Anesthesiologists classification.
- Contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic pyeloplastyThe first trocar was inserted under vision through the same supraumbilical incision and the intraperitoneal cavity was inspected The second 5 mm trocar was placed in the midclavicular line 2 inches below the costal margin. The third 10 mm trocar was placed lateral to the rectus muscle at the level of the anterior superior iliac spine. In right-sided pyeloplasty, a fourth trocar was inserted below the xiphistemum for liver retraction. Incision of the line of Toldt and mobilization of the colon was the first step of the transperitoneal approach. A 4/0 polysorbe stay suture was taken in the lateral aspect of the ureter distal to uretero-pelvic junction obstruction to identify the correct orientation after dismembering the ureter. A full thickness anastomosis was started from the angle of V shape spatulation to the lower pole of the renal pelvis. | Procedure or surgery | Laparoscopic pyeloplasty |
| Open pyeloplastyA flank incision with the patient in lateral position was undertaken in open pyeloplasty. After accessing the retro- peritoneum, the ureter was identified and traced cranially till the PUJ segment. Traction sutures was placed on the renal pelvis followed by excision of the narrowing segment. The ureter was spatulated by approximately 2 cm and a reduction pyeloplasty was performed, where necessary. Anastomosis was undertaken using vicryl 4-0 sutures. The primary anastomotic site was sutured in interrupted fashion followed by a continuous running suture of the posterior wall. Next, antegrade DJ stenting was performed and the anterior wall was anastomosed. After haemostatic control a 22 Fr drain was placed in the surgical bed. | Procedure or surgery | Open pyeloplasty |
Primary outcome
Amount of blood loss
Time frame: Intraoperatively
Amount of blood loss was recorded.
2 secondary outcomes
Etiology of obstruction
Time frame: Intraoperatively
Complications
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic pyeloplasty and Open pyeloplasty in people with Open and Laparoscopic, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood loss (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.