Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503627
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Incidence of Caesarean Scar Defect in Cases of Cesarean Section With and Without Bladder Flap Dissection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence of Caesarean Scar Defect in Cases of Cesarean Section With and Without Bladder Flap Dissection
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anatomically Uterine niche is an iatrogenic pouch-like defect at the site of previous caesarean scar due to defective tissue healing Radiologically niche should be defined as an indentation at the site of the CS scar with a depth of at least 2 mm A niche can be subclassified in 1 simple niche 2 simple niche with one branch 3 complex niche with more than one branch 1-3 Uterine niche occurs in up to 70 women with previous cesarean of whom 30 are symptomatic Reported prevalence varies 24-70 with transvaginal sonography TVS and 56-84 with gelsaline instillation sonohysterography SHGThis may be an underestimation because many women are asymptomatic and also because clinicians may not recognize niche as a cause of symptoms due to unawareness Prevalence of 456 was reported in a prospective observational study n 371 where sonohysterography was done six months post-cesarean Prevalence increases with increasing number of previous cesareans 1-5 Potential Risk Factors Niche forms due to poor healing of cesarean scar Risk factors are 5-8
1 Factors Affecting Lower Uterine Segment
Cervical dilatation of 5 cm 5 h duration of labour and advanced fetal station predispose to large niche due to thinner or less vascularized myometrium resulting in inadequate healing56
2 Level of Uterine Incision Lower uterine incision towards the cervix results in poor healing as mucus secreted by cervical glands interferes with myometrial approximation Mucus accumulation gradually increases the niche size also 57 Cesarean section done in advanced labour after cervical effacement and also creation of uterovesical fold of peritoneum influence the level of uterine incision
3 Uterine Closure Techniques Single-layer decidua sparing closure technique predisposes to incomplete closure compared to single full-thickness closure A strong myometrial scar with proper anatomical approximation without tissue strangulation minimizes risk of niches 18 If muscular edges are thick they are best approximated by including deeper part in the first layer and the remaining superficial cut edges in the second layer
Non-perpendicular sutures leading to an irregular myometrial closure locking sutures or very tight second layer leading to ischemic necrosis result in poorly healed scar predisposing to niche formation
Thus double-layer uterine closure using non-locking sutures is the optimal closure technique that results in thicker residual myometrium and hence potentially lower risk of niches
Suboptimal surgical techniques Inadequate haemostasis tissue ischemia devascularization and excessive tissue manipulation contribute to poor scar healing and adhesions consequently forming niche
4 Adhesions Adhesion formation with abdominal wall pulls the uterine scar towards abdominal wall exerting counteracting force opposite to the direction of retracting uterine scar tissue and causing impaired wound healing This mechanism is encountered in non closure of peritoneum and creation of bladder flap that is not sutured 7
5 Retroflexed Uterus Effect of gravity on uterine corpus also increases counteracting forces Large niches are mostly found with retroflexed uterus 67
6 Patient Factors Genetic predisposition contributes to impaired healing inflammation or adhesion formation post-operative infection 7 Gestational diabetes odds ratio 173 previous caesarean OR 314 and advanced body mass index OR 106 are independent risk factors Risk increases by 6 for every additional unit increase in body mass index 8
Diagnosis
Niche can be visualized in non-pregnant state using TVS SHG 3-D ultrasound magnetic resonance imaging or hysteroscopy An anechoic space at least 2 mm deep in the myometrium at caesarean scar site clinches the diagnosis Niche Size and Residual Myometrium thickness are measured
Residual myometrial thickness RMT is the vertical distance between uterine serosa and apex of defect Large niches are defined when RMT is 50 of adjacent myometrium or 22 mm on TVS Absent residual myometrium is termed a total defect 910
1 Factors Affecting Lower Uterine Segment
Cervical dilatation of 5 cm 5 h duration of labour and advanced fetal station predispose to large niche due to thinner or less vascularized myometrium resulting in inadequate healing56
2 Level of Uterine Incision Lower uterine incision towards the cervix results in poor healing as mucus secreted by cervical glands interferes with myometrial approximation Mucus accumulation gradually increases the niche size also 57 Cesarean section done in advanced labour after cervical effacement and also creation of uterovesical fold of peritoneum influence the level of uterine incision
3 Uterine Closure Techniques Single-layer decidua sparing closure technique predisposes to incomplete closure compared to single full-thickness closure A strong myometrial scar with proper anatomical approximation without tissue strangulation minimizes risk of niches 18 If muscular edges are thick they are best approximated by including deeper part in the first layer and the remaining superficial cut edges in the second layer
Non-perpendicular sutures leading to an irregular myometrial closure locking sutures or very tight second layer leading to ischemic necrosis result in poorly healed scar predisposing to niche formation
Thus double-layer uterine closure using non-locking sutures is the optimal closure technique that results in thicker residual myometrium and hence potentially lower risk of niches
Suboptimal surgical techniques Inadequate haemostasis tissue ischemia devascularization and excessive tissue manipulation contribute to poor scar healing and adhesions consequently forming niche
4 Adhesions Adhesion formation with abdominal wall pulls the uterine scar towards abdominal wall exerting counteracting force opposite to the direction of retracting uterine scar tissue and causing impaired wound healing This mechanism is encountered in non closure of peritoneum and creation of bladder flap that is not sutured 7
5 Retroflexed Uterus Effect of gravity on uterine corpus also increases counteracting forces Large niches are mostly found with retroflexed uterus 67
6 Patient Factors Genetic predisposition contributes to impaired healing inflammation or adhesion formation post-operative infection 7 Gestational diabetes odds ratio 173 previous caesarean OR 314 and advanced body mass index OR 106 are independent risk factors Risk increases by 6 for every additional unit increase in body mass index 8
Diagnosis
Niche can be visualized in non-pregnant state using TVS SHG 3-D ultrasound magnetic resonance imaging or hysteroscopy An anechoic space at least 2 mm deep in the myometrium at caesarean scar site clinches the diagnosis Niche Size and Residual Myometrium thickness are measured
Residual myometrial thickness RMT is the vertical distance between uterine serosa and apex of defect Large niches are defined when RMT is 50 of adjacent myometrium or 22 mm on TVS Absent residual myometrium is termed a total defect 910
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None