The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty. A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in complications rate
研究概览
简要总结
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:
- Is it safe with similar post-operative outcomes?
- Does it have any significant complications?
- Is it easier to handle intra-operatively?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Barbed suture group
Pyeloplasty done using barbed absorbable sutures
干预措施: Barbed suture (Device)
PGA group
Pyeloplasty done using conventional PGA (Polyglactin) sutures
干预措施: PGA suture (Device)
结局指标
主要结局
Difference in complications rate
时间窗: 18 months (Post-operative data)
Mean difference in complications rate between both groups
Drain output post-operative
时间窗: 12 months (Early post-operative data)
Mean difference in total drain output between both groups
Time difference for suture completion
时间窗: 12 months (Intra-operative data)
Mean difference of time taken in minutes between each group
次要结局
- Difference in total operative time(12 months (Intra-operative data))
- Failure rate(18 months (Late post-operative data))
- Difference in hospitalization time(12 months (Early post-operative data))
研究者
Mohamed Ahmed Mohamed Fakhry Makki
Urology Specialist in Cairo University Hospital, Principal investigator, MD Candidate
Cairo University