Clinical trial NCT04241107: Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial
Official title: Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Niche
Keywords: Cesarean Scar defect
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. The decision to treat takes into consideration the size of the defect, presence of symptoms, secondary infertility and plans of pregnancy.

All of the approaches have its merits and debates. There is ongoing debate regarding the best surgical approach to managing this condition. To date no randomized controlled trials have been published to settle this debate.

Our study aim is to to evaluate which surgical approach is a preferable option, this study will be conducted to compare the Laparoscopic and transvaginal approaches in several regards, including, operation time, blood loss, perioperative complications, hospital stay length, postoperative increase in residual myometrial thickness during follow-up , clinical efficacy(percentage of patients who subject improvement of symptoms)


Eligibility criteria: Inclusion Criteria:

- Patients who have uterine niche (defined as myometrial discontinuity or a hypoechoic triangle in the myometrium of the anterior uterine wall at the site of hysterotomy presented in transvaginal ultrasound or sonohysterography examination in non-pregnant women) ,with one or more previous caesarean section Who are:

1. Symptomatic i.e patients having one or more of the following symptoms:

   1. Postmenstrual spotting (defined as more than 2 days of brownish discharge at the end of menstruation with a total length of menstruation (including spotting) of more than 7 days, or intermenstrual bleeding which starts within 5 days after the end of menstruation. \[15\]),
   2. Secondary Dysmenorrhea( defined as the pain or discomfort associated with menstruation)
   3. deep dyspareunia(deep genital pain associated with sexual intercourse)
   4. Chronic pelvic pain can be defined as intermittent or constant pain in the lower abdomen or pelvis of a woman of at least 6 months in duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy.
   5. secondary infertility (defined by the World Health Organization as, -when a woman is unable to bear a child, either due to the inability to become pregnant or the inability to carry a pregnancy to a live birth following either a previous pregnancy or previous ability to carry a pregnancy to a live birth.)
2. Asymptomatic patients with one of the followings:

   the residual myometrial thickness over the niche less than 3 mm previous history of Cesarean Section scar ectopic pregnancy (not managed by resection and repair)
3. who accept to participate the study.

Exclusion Criteria:

1. Asymptomatic patients with residual myometrial thickness more than 3 mm.
2. No previous Cesarean section.
3. If the patients symptoms presented before Cesarean section.
4. Presence of other pathology that explain patient symptoms

   1. sub mucous fibroid
   2. cervical-Endometrial carcinoma
   3. Endometrial hyperplasia
   4. Coagulation defect.
5. Presence of pathology that necessitate laparotomy.
6. Patient who refuse to participate the study.

Primary outcomes:
measure: Clinical efficacy
timeFrame: 3 month postoperative
measure: Post-operative increase in residual myometrial thickness
timeFrame: 3 month postoperative
Secondary outcomes:
measure: Duration of operation
timeFrame: baseline( During operation)
measure: Blood loss
timeFrame: baseline( During operation)
measure: Intra-operative complication
timeFrame: baseline( During operation)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Abdulrahman Muhammad Rageh
Study officials:
affiliation: Assiut University
name: Mahmoud Abdel-Aleem, PhD
role: STUDY_CHAIR
affiliation: Assiut University
name: Mahmoud zakhera, PhD
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Abo El Fadle, MD
role: STUDY_CHAIR
References:
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