跳至主要内容
临床试验/NCT04307524
NCT04307524Unknown2 期

Laparoscopic Repair Of Cesarean Scar Niche: Randomized Controlled Trial.

Zagazig University0 个研究点目标入组 30 人开始时间: 2020年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
30
主要终点
post-menstrual spotting

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

computer-generated sequence

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • History of cesarean section.
  • Postmenstrual and/or intermenstrual spotting.
  • Cesarean scar niche of at least 2 mm in depth diagnosed by saline infusion sonography

排除标准

  • Uterine anomalies
  • Hysterotomy.
  • history Placenta previa and MAP
  • Upper segment incision, Vertical uterine incision
  • submucosal fibroids
  • adenomyosis.
  • History atypical endometrial cells, cervical dysplasia,
  • cervical or pelvic infection.
  • Irregular cycle.
  • lactation amenorrhea.

研究组 & 干预措施

laparoscopic repair

Experimental

suture repair of cesarean scar niche using laparoscopy

干预措施: laparoscopic repair (Procedure)

medical treatment

Active Comparator

conservative management

干预措施: medical treatment in the form of combined hormonal contraception (Drug)

结局指标

主要结局

post-menstrual spotting

时间窗: 6 month after intervention

number of days of post-menstrual spotting "spotting or bleeding after 8 days of menstruation whatever the amount

次要结局

  • menstrual related pain(6 month after intervention)
  • infertility(6 month after intervention)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mahmoud Ismail Abdel Rahman Kotb

Specialist & Assistant Lecturer of obstetrics and gynecology

Zagazig University

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