Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483724
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-25
Brief Title:
Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum A Prospective Interventional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation
Detailed Description:
Study Design and Setting This was prospective interventional study that comprised the medical data of 82 pregnant women with placenta accreta who had caesarean section This study will be carried out In the Department of Obstetrics and Gynecology Minia Maternity University Hospital MMUH
after being approved by the local ethical Committee If placenta accreta was clinically verified preoperatively all parturients were informed of the option of a hysterectomy After receiving written formal consent After receiving documented formal consent The study included all patients who had a scheduled cesarean procedure for placenta accreta Obstetrical imaging either verified or strongly suspected the diagnosis During the prenatal period a senior sonographer evaluated all patients using ultrasonography and color Doppler technology An ultrasonographic assessment was done Each patient was evaluated for retroplacental sonolucent zones vascular lacunas myometrial thinning bladder line disruption and exophytic masses The Color Doppler scan evaluated placental lacunar flow hypervascularity in the vesicouterine interface and continuous retroplacental venous complex structures A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase as well as uneven intraplacental vascularization
Assessment
To assess the effectiveness of the proposed management strategy participants were separated into two groups In Group 1 n 41 a cervical tourniquet was used systematically In Group 2 n41 uterine artery ligation was performed prior to segmental resection for uterine preservation surgery
Surgical scenarios
Across both groups Ultrasonographic data determine whether an abdominal incision should be performed with a Pfannensteil or a vertical midline incision from under the umbilicus to above the pubic symphysis
1 in group 1 After opening the abdominal wall To reduce bleeding during PAS make the uterine incision above the placentas intrauterine borders Before making the incision an ultrasound check is recommended to find the uterine opening Based on our assumptions following the delivery of the fetus
2 investigators was extract the uterus from the abdomen by gently grasp the fundus of the uterus and pull up and forward Release uterine appendages on both sides by shifting the uterus to the right and left
3 An assistant slides a sterile Foley catheter Ch 1618 French down to the lowest point and secures it en bloc around the cervix at the level of the uterosacral ligaments approximately 3-4 cm below the incision Then tighten and fix it
4 The bladder peritoneum is isolated from the uterus through complex coagulation of perforating vascular systems This step of surgery is crucial for the rest of the treatment Due to the fragile and unpredictable nature of the vascular network it is important to exercise caution The bladder peritoneum is demarcated until the cervical internal ostium To accomplish this procedure an assistant places a finger on the anterior fornix of the vagina to create a reference point and assure full separation
5 To remove myometrial tissue leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors
6 The tourniquet approach achieves hemostasis giving the operator time to assess the uteruss preservation potential
7 To assess active bleeding the tourniquet can be removed
8 Suturing on the uterine pouches by suturing on the Uterine pouches is repaired by bringing the edges together with running sutures or using the internal os of the cervix as a natural tamponade helps produce hemostasis in the placental bed and adjacent areas
9 This approach provides time to prepare for a blood transfusion or seek assistance The tourniquet approach can be utilized as both a primary therapy strategy for PAS and a follow-up after placental removal and bleeding
In another group the same steps in group 1 in steps 1 2 and 3 4- The bladder peritoneum is isolated from the uterus 5 - The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side
6- the same steps in group 1 in steps 56 7and 8
after being approved by the local ethical Committee If placenta accreta was clinically verified preoperatively all parturients were informed of the option of a hysterectomy After receiving written formal consent After receiving documented formal consent The study included all patients who had a scheduled cesarean procedure for placenta accreta Obstetrical imaging either verified or strongly suspected the diagnosis During the prenatal period a senior sonographer evaluated all patients using ultrasonography and color Doppler technology An ultrasonographic assessment was done Each patient was evaluated for retroplacental sonolucent zones vascular lacunas myometrial thinning bladder line disruption and exophytic masses The Color Doppler scan evaluated placental lacunar flow hypervascularity in the vesicouterine interface and continuous retroplacental venous complex structures A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase as well as uneven intraplacental vascularization
Assessment
To assess the effectiveness of the proposed management strategy participants were separated into two groups In Group 1 n 41 a cervical tourniquet was used systematically In Group 2 n41 uterine artery ligation was performed prior to segmental resection for uterine preservation surgery
Surgical scenarios
Across both groups Ultrasonographic data determine whether an abdominal incision should be performed with a Pfannensteil or a vertical midline incision from under the umbilicus to above the pubic symphysis
1 in group 1 After opening the abdominal wall To reduce bleeding during PAS make the uterine incision above the placentas intrauterine borders Before making the incision an ultrasound check is recommended to find the uterine opening Based on our assumptions following the delivery of the fetus
2 investigators was extract the uterus from the abdomen by gently grasp the fundus of the uterus and pull up and forward Release uterine appendages on both sides by shifting the uterus to the right and left
3 An assistant slides a sterile Foley catheter Ch 1618 French down to the lowest point and secures it en bloc around the cervix at the level of the uterosacral ligaments approximately 3-4 cm below the incision Then tighten and fix it
4 The bladder peritoneum is isolated from the uterus through complex coagulation of perforating vascular systems This step of surgery is crucial for the rest of the treatment Due to the fragile and unpredictable nature of the vascular network it is important to exercise caution The bladder peritoneum is demarcated until the cervical internal ostium To accomplish this procedure an assistant places a finger on the anterior fornix of the vagina to create a reference point and assure full separation
5 To remove myometrial tissue leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors
6 The tourniquet approach achieves hemostasis giving the operator time to assess the uteruss preservation potential
7 To assess active bleeding the tourniquet can be removed
8 Suturing on the uterine pouches by suturing on the Uterine pouches is repaired by bringing the edges together with running sutures or using the internal os of the cervix as a natural tamponade helps produce hemostasis in the placental bed and adjacent areas
9 This approach provides time to prepare for a blood transfusion or seek assistance The tourniquet approach can be utilized as both a primary therapy strategy for PAS and a follow-up after placental removal and bleeding
In another group the same steps in group 1 in steps 1 2 and 3 4- The bladder peritoneum is isolated from the uterus 5 - The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side
6- the same steps in group 1 in steps 56 7and 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None