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Intraoperative Ureteric Dissection vs Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta

Primary Purpose

Placenta Accreta

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ureteric dissection
Preoperative ureteric stenting
Cesarean hysterectomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Accreta

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intra operative ureteric dissection

Preoperative ureteric stenting

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2018
Last Updated
December 3, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03763916
Brief Title
Intraoperative Ureteric Dissection vs Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta
Official Title
Comparative Study Between Intraoperative Ureteric Dissection and Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra operative ureteric dissection
Arm Type
Active Comparator
Arm Description
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
Arm Title
Preoperative ureteric stenting
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ureteric dissection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Preoperative ureteric stenting
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cesarean hysterectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature
Time Frame
during the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parity; multiparas Advanced gestational age more than 36 weeks Repeated cesarean sections Placenta previa Abnormally invasive placenta diagnosed and confirmed by senior sonographer Exclusion Criteria: Morbidly obese patient [BMI over 35] Severly anaemic; patients[ Hb less than 8gmLdl] Elderly females [age over 40] Inability to insert ureteric stent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Alsawaf, MD
Phone
+201223380269
Email
hsawaf40@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intraoperative Ureteric Dissection vs Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta

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