- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763916
Intraoperative Ureteric Dissection vs Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta
Comparative Study Between Intraoperative Ureteric Dissection and Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Maged, MD
- Phone Number: +201005227404
- Email: prof.ahmedmaged@gmail.com
Study Contact Backup
- Name: Ahmed Alsawaf, MD
- Phone Number: +201223380269
- Email: hsawaf40@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 12151
- Kasr Alainy medical school
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
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.
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature
Time Frame: during the operation
|
during the operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Placenta Accreta
-
Kasr El Aini HospitalUnknownPlacenta Accreta in Placenta Previa Anterior
-
Ain Shams Maternity HospitalCompleted
-
Maternal and Child Health Hospital of FoshanWithdrawnPlacenta Accreta SpectrumChina
-
Sohag UniversityRecruiting
-
Necmettin Erbakan UniversityRecruitingPlacenta Accreta, Third TrimesterTurkey
-
Ain Shams UniversityNot yet recruiting
-
Ain Shams UniversityUnknownPlacenta Accreta, Third TrimesterEgypt
-
HaEmek Medical Center, IsraelTechnion, Israel Institute of TechnologyUnknown
-
Cairo UniversityRecruitingPlacenta Accreta Spectrum | Cesarean HysterectomyEgypt
-
Hatem AbuHashimCompletedPlacenta Accreta SpectrumEgypt
Clinical Trials on Ureteric dissection
-
The Adelaide and Meath Hospital, incorporating...WithdrawnSepsis | Hydronephrosis | Ureteric CalculusIreland
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Alrijne HospitalCompletedKidney Diseases | Urologic Diseases | Kidney Calculi | Urinary Calculi | Urolithiasis | Stone Ureter | Stone, Kidney | Urinary Stone | Pyelonephritis | Hydronephrosis | Obstruction | Kidney Failure, Acute | Ureter Obstruction | Urinary Obstruction | Kidney Dysfunction | Kidney Insufficiency | Pyelonephritis Acute | Stone, Urinary and other conditionsNetherlands
-
Ethicon Endo-SurgeryChildren's Hospital Medical Center, CincinnatiTerminated
-
Chinese PLA General HospitalUnknown
-
Cairo UniversityRecruitingPlacenta Accreta Spectrum | Cesarean HysterectomyEgypt
-
Guang-Yan YuNational Natural Science Foundation of China; Peking University School of StomatologyRecruiting
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedPatients With Papillary Thyroid Cancer and N1b StatusItaly
-
Shanghai Zhongshan HospitalNot yet recruiting
-
Eastern Hepatobiliary Surgery HospitalUnknownIntrahepatic CholangiocarcinomaChina