Pelvi-Ureteric Obstruction
Conditions
Keywords
Pyeloplasty, Dismembered pyeloplasty, Laparoscopic pyeloplasty, Robot-assisted pyeloplasty, Barbed suture
Brief summary
The main goals of this trial is to study the feasibility and safety of using barbed sutures compared to the conventional PGA (Polyglactin) sutures in minimally invasive dismembered pyeloplasty. The main questions in using barbed sutures would be: 1. Is it safe with similar post-operative outcomes? 2. Does it have any significant complications? 3. Is it easier to handle intra-operatively?
Detailed description
Minimally invasive surgeries for pelviureteric junction obstruction have become more popular in the past decade than open surgery. This is to decrease the morbidity for patients and attain better patient satisfaction especially for having a significantly smaller incisions compared to open flank and midline abdominal incisions. Minimally invasive surgery is a term used to describe surgeries that would spare the patient a long incision and hence spares him also the pain and risk of wound infection associated with it. In this study the investigators will focus only on laparoscopy and robot-assisted surgeries. Pelviureteric junction obstruction is a disease that is not uncommon with an incidence of 1 in 1000-1500. Although usually it is diagnosed in the pediatric population, it is not uncommon in adults. PUJO (Pelviureteric junction obstruction) could have it's impact on the patient's quality of life as if it is not treated it could decrease the split glomerular filtration rate due to impaired drainage. It also could present with secondary renal stones, pain, recurrent upper urinary tract infection, fever and urosepsis. Management of PUJO (Pelviureteric junction obstruction) starts with the proper assessment of the patient regarding his age and careful history taking and physical examination, evaluation of laboratory investigations such as urine culture and sensitivity, serum creatinine, total leucocytic count. Also, evaluation of the pelviabdominal ultrasound, intravenous pyelography, and diuretic renogram. Treatment of PUJO (Pelviureteric junction obstruction) ranges from active surveillance, endopyelotomy and ureteral stenting, and pyeloplasty whether it is open, laparoscopic or robot-assisted. Traditionally, absorbable polyglactin sutures is used for dismembered pyeloplasty. Yet recently barbed sutures have gained popularity within urologists especially in minimally invasive surgeries. Barbed knotless uni-directional sutures have the benefit of being knotless and evenly distributes tension so there is no need for the assistant to follow the surgeon and stretch the suture, this significantly decreases the operative time and frees the assistant's port to be able to do other steps. Barbed sutures have been well established in other surgical fields such as bariatric surgery, gynecology, and skin closure previously, and recently it has been populated in the urological community especially in the vesicourethral anastomosis in Radical prostatectomy. Sparse yet promising articles have been published regarding the use of barbed sutures in pyeloplasty which could change the way surgeons approach the disease.
Interventions
DEVICEBarbed suture
Use of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
DEVICEPGA suture
Use of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization is done using a web-based platform, group assignment will only be known to the surgeon (care provider). It would be concealed to the patient, investigator, and outcomes assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 60 undergoing robotic or laparoscopic dismembered pyeloplasty * History of dietls' crisis (Fever, pain) in a pelviureteric junction obstructed kidney * Decrease in glomerular filtration rate in a pelviureteric junction obstructed kidney
Exclusion criteria
* Contraindications for laparoscopy or robotic surgery as pulmonary obstructive or restrictive disease, and poor cardiovascular fitness * Uncontrolled diabetes mellitus * Morbid obesity * History of multiple major abdominal surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time difference for suture completion | 12 months (Intra-operative data) | Mean difference of time taken in minutes between each group |
| Difference in complications rate | 18 months (Post-operative data) | Mean difference in complications rate between both groups |
| Drain output post-operative | 12 months (Early post-operative data) | Mean difference in total drain output between both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in total operative time | 12 months (Intra-operative data) | Mean difference in total operative time post-operative |
| Difference in hospitalization time | 12 months (Early post-operative data) | Mean difference in hospitalization time |
| Failure rate | 18 months (Late post-operative data) | Difference in number of patients who needed redo pyeloplasty or any auxiliary procedures |
Countries
Egypt
Outcome results
None listed