跳至主要内容
临床试验/NCT03763916
NCT03763916Unknown不适用

Comparative Study Between Intraoperative Ureteric Dissection and Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta

Cairo University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature

研究概览

简要总结

80 Egyptian pregnant female patients will be enrolled in our prospective study. All candidates will have the diagnosis of placenta percreta [confirmed by 2D and 3D ultrasound and Doppler by senior sonographer]. All candidates will be scheduled for cesarean hysterectomy; patients will be randomized into two groups, first group will include 40 patients who will undergo cesarean hysterectomy with intraoperative ureteric dissection, and the second group will include the other 40 patients who will undergo cesarean hysterectomy with preoperative ureteric stenting.

详细描述

80 pregnant females with the diagnosis of Abnormally invasive placenta [AIP] will be involved in our study [ after proper sample size calculation]. The diagnosis Of AIP will be confirmed by 2D and 3D ultrasound as well as power Doppler evaluation [machine]. Sonographic evaluation will be done and confirmed by senior sonographer in our ACCRETA team.

Patients will be randomized into two groups using closed envelopes after taking written consents; group 1 with intraoperative ureteric dissection and group 2 with preoperative ureteric stenting.

In group 1 cesarean hysterectomy is performed with intra operative ureteric dissection; midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection and splitting of the recti, classic midline incision of the uterus [above the site of placental insertion], delivery of the fetus in presence of a well trained neonatology team, avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels so as to facilitate the ligation of anterior division of internal iliac artery if needed and to avoid any major vascular injury, if unfortunately severe bleeding occurs and rapid surgical intervention is needed. Following ureteric dissection is performed lateral dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the placenta with or without complete removal of the cervix. Closure of the uterine stump is performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after leaving two wide bore drains.

In group2; preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter. Ureteral catheters are fixed to the Foley's catheter. the ureteric catheters are scheduled for removal immediately postoperative. The patient is then placed in the supine position and sterilization of the abdominal wall is performed and cesarean hysterectomy is performed similarly as in the first group but without ureteric dissection.

The two groups will be carefully studied as regards to incidence of ureteric and bladder injuries, amount of blood loss [measured by weighing towels pre and postoperative; the difference represents the intraoperative blood loss] and the intraoperative timing. Statistical comparison between the rate of complications in each groups will be done. Patients' data will be analyzed statistically using SAS program (SAS, 1996).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parity; multiparas
  • Advanced gestational age more than 36 weeks
  • Repeated cesarean sections
  • Placenta previa
  • Abnormally invasive placenta diagnosed and confirmed by senior sonographer

排除标准

  • Morbidly obese patient [BMI over 35] Severly anaemic; patients[ Hb less than 8gmLdl] Elderly females [age over 40]
  • Inability to insert ureteric stent

研究组 & 干预措施

Intra operative ureteric dissection

Active Comparator

midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection and splitting of the recti, classic midline incision of the uterus [above the site of placental insertion], delivery of the fetus , avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels

干预措施: Ureteric dissection (Procedure)

Intra operative ureteric dissection

Active Comparator

midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection and splitting of the recti, classic midline incision of the uterus [above the site of placental insertion], delivery of the fetus , avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels

干预措施: Cesarean hysterectomy (Procedure)

Preoperative ureteric stenting

Active Comparator

preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter.

干预措施: Preoperative ureteric stenting (Procedure)

Preoperative ureteric stenting

Active Comparator

preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter.

干预措施: Cesarean hysterectomy (Procedure)

结局指标

主要结局

ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature

时间窗: during the operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Principal investigator

Cairo University

研究点 (2)

Loading locations...

相似试验

Intraoperative Ureteric Dissection vs Preoperative... | 临床试验