Laparoscopic Repair of Cesarean Scar Niche

NCT ID: NCT04307524

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2021-03-30

Brief Summary

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

Detailed 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

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

laparoscopic repair

suture repair of cesarean scar niche using laparoscopy

Group Type: EXPERIMENTAL

laparoscopic repair

Intervention Type: PROCEDURE

laparoscopic suture repair of cesarean scar niche

medical treatment

conservative management

Group Type: ACTIVE_COMPARATOR

medical treatment in the form of combined hormonal contraception

Intervention Type: DRUG

patient will receive for three months daily without interruption, no pill-free interval drug names is "Genera" BAYERhealthcare

Interventions

laparoscopic repair

laparoscopic suture repair of cesarean scar niche

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mahmoud Ismail Abdel Rahman Kotb

Specialist & Assistant Lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

cesarean scar niche

Identifier Type: -

Identifier Source: org_study_id