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

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ClinicalTrials.gov Identifier: NCT03763916
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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.

Condition or disease Intervention/treatment Phase
Placenta Accreta Procedure: Ureteric dissection Procedure: Preoperative ureteric stenting Procedure: Cesarean hysterectomy Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Study Between Intraoperative Ureteric Dissection and Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: 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 , 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
Procedure: Ureteric dissection
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

Procedure: Cesarean hysterectomy
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

Active Comparator: Preoperative ureteric stenting
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.
Procedure: Preoperative ureteric stenting
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

Procedure: Cesarean hysterectomy
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 Measures :
  1. ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature [ Time Frame: during the operation ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763916


Contacts
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Contact: Ahmed Maged, MD +201005227404 prof.ahmedmaged@gmail.com
Contact: Ahmed Alsawaf, MD +201223380269 hsawaf40@yahoo.com

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Professor

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Responsible Party: Ahmed Maged, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03763916     History of Changes
Other Study ID Numbers: 44
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases