Laparoscopic Repair of Cesarean Scar Niche

Cesarean Section Complications Clinical Trial

Official title:

Laparoscopic Repair Of Cesarean Scar Niche: Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04307524
• Other study ID #: cesarean scar niche
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 15, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management.

Description:

Recently, The percentage of Cesarean section (CS) deliveries has dramatically increased in most countries. The presence of a niche at the site of a CS scar has been observed. A niche is mainly a sonographic finding defined as a triangular anechoic area at site of incision. ( Mascarello et al, 2017) Alternative terms for a niche are Cesarean scar defect (Wang et al, 2009), deficient Cesarean scar (Ofili-Yebovi et al, 2008), diverticulum (Surapaneni et al, 2008), pouch (Fabres el al, 2003) and isthmocele. (bogres el al, 2010) As not all women with previous CS develop a niche, it is a matter of interest to identify the risk factors that may predict their development. (Sholapurkar , 2018) Possible causes of this condition may be surgery or patient related. Surgery related factors as low cervical incision, incomplete closure of the uterus (decidual sparing) and inadequate hemostasis. Patient related factors may be attributed to infection. ( Vervoort et al, 2015) Cesarean scar niche may be asymptomatic or may cause a number of obstetrical and gynecological problems (cesarean scar syndrome) . ( Vervoort et al,2015b) Obstetrical complications of the niche are cesarean scar ectopic pregnancy, placenta previa and morbidly adherent placenta, cesarean scar dehiscence following incomplete abortion secondary to uterotonic drugs, Scar dehiscence and tender scar even scar rupture (Tanimura el al, 2015) Gynecological symptoms of the niche are postmenstrual spotting, Intermenstrual bleeding, Dysmenorrheal, Dysparunia and secondary infertility. (Tanimura el al, 2015) Various methods to detect and measure a niche have been described. The majority of papers have evaluated the niche with the use of transvaginal sonography (TVS) (Vaate et al, 2011), and contrast‐enhanced sonohysterography (SHG) (Bij de Vaate et al, 2011), but a minority have used hysteroscopy (El-Mazny et al, 2011) or hysterosalpingography. (Surapaneni and Silberzweig, 2008 ) At present there is no consensus regarding the gold standard for the detection and measurement of a niche. (Vaate et al, 2014) Symptomatic cesarean scar niche (cesarean scar syndrome) can be managed conservatively using combined oral contraceptive pills especially in women not seeking fertility, or it can be treated using minimal invasive surgery as hysteroscopic resection (vervoot et al,2017) , laparoscopic repair (ma et al,2017) or vaginal repair (Yao, 2014) In this study we will evaluate laparoscopic management of cesarean scar niche

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. History of cesarean section.

2. Postmenstrual and/or intermenstrual spotting.

3. Cesarean scar niche of at least 2 mm in depth diagnosed by saline infusion sonography

Exclusion Criteria:

1. pregnancy

2. Uterine anomalies

3. Hysterotomy.

4. history Placenta previa and MAP

5. Upper segment incision, Vertical uterine incision

6. submucosal fibroids

7. adenomyosis.

8. History atypical endometrial cells, cervical dysplasia,

9. cervical or pelvic infection.

10. Irregular cycle.

11. lactation amenorrhea.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• laparoscopic repair
laparoscopic suture repair of cesarean scar niche

Drug:
• medical treatment in the form of combined hormonal contraception
patient will receive for three months daily without interruption, no pill-free interval drug names is "Genera" BAYERhealthcare

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-menstrual spotting	number of days of post-menstrual spotting "spotting or bleeding after 8 days of menstruation whatever the amount	6 month after intervention
Secondary	menstrual related pain	degree of menstrual related pain as descriped by the patient on Visual Analogue Scale of pain from 1 to 10	6 month after intervention
Secondary	infertility	failure of conception despite regular sexual intercourse within 6 months from intervention or stopping gynera	6 month after intervention