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

NCT03763916 | Unknown DMC

• 1 other identifier: 44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

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

  during the operation

Study Arms (2)

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

Procedure: Ureteric dissection; Procedure: Cesarean hysterectomy

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.

Procedure: Preoperative ureteric stenting; Procedure: Cesarean hysterectomy

Interventions

Ureteric dissection PROCEDURE

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

Intra operative ureteric dissection

Preoperative ureteric stenting PROCEDURE

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

Preoperative ureteric stenting

Cesarean hysterectomy PROCEDURE

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

Intra operative ureteric dissection; Preoperative ureteric stenting

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

Ahmed Alsawaf, MD

CONTACT

+201223380269; hsawaf40@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: December 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 4, 2018

Record last verified: 2018-12

Locations

EG (1)