Laparoscopic Repair of Cesarean Scar Niche

Laparoscopic Repair Of Cesarean Scar Niche: Randomized Controlled Trial.

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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: laparoscopic repair; Drug: medical treatment in the form of combined hormonal contraception

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic repair; suture repair of cesarean scar niche using laparoscopy	Procedure: laparoscopic repair; laparoscopic suture repair of cesarean scar niche
Active Comparator: medical treatment; conservative management	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
infertility	failure of conception despite regular sexual intercourse within 6 months from intervention or stopping gynera	6 month after intervention

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2020
• Primary Completion (Anticipated): March 15, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cesarean scar niche
• Other Study ID Numbers: cesarean scar niche

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No