Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526559
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty A Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 its impact on the patients 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 assistants 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
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 its impact on the patients 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 assistants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None