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Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial (isthmocele)

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ClinicalTrials.gov Identifier: NCT04241107
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Abdulrahman Muhammad Rageh, Assiut University

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)


Condition or disease Intervention/treatment Phase
Uterine Niche Procedure: Laparoscopic repair of Uterine niche Procedure: Transvaginal repair of Uterine niche Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Active Comparator: Laparoscopic approach group(A)
Uterine niche will be repaired through Laparoscopic approach.
Procedure: Laparoscopic repair of Uterine niche
Repair of uterine niche through Laparoscopic approach.

Active Comparator: Transvaginal approach group(B)
Uterine niche will be repaired through Transvaginal approach.
Procedure: Transvaginal repair of Uterine niche
Repair of uterine niche through Transvaginal approach.




Primary Outcome Measures :
  1. Clinical efficacy [ Time Frame: 3 month postoperative ]
    Number of patients who subject clinical improvement of pre-operative symptoms

  2. Post-operative increase in residual myometrial thickness [ Time Frame: 3 month postoperative ]
    difference between pre-operative & post-operative residual myometrial thickness


Secondary Outcome Measures :
  1. Duration of operation [ Time Frame: baseline( During operation) ]
    duration from anesthesia till end of operation

  2. Blood loss [ Time Frame: baseline( During operation) ]
    estimated blood loss during operation(towels , suction container)

  3. Intra-operative complication [ Time Frame: baseline( During operation) ]
    complication during the operation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241107


Contacts
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Contact: Abdulrahman Muhammad Rageh, M.Sc 02 01005056259 Abdulrahmanrageh.26.9@gmail.com

Locations
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Egypt
Abdulrahman Muhammad Rageh Recruiting
Assiut, Egypt, 71111
Contact: Abdulrahman Muhammad Rageh, MSc    +201005056259    Abdulrahmanrageh.26.9@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mahmoud Abdel-Aleem, PhD Assiut University
Study Chair: Mahmoud zakhera, PhD Assiut University
Study Chair: Ahmed Abo El Fadle, MD Assiut University
Additional Information:
Publications:

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Responsible Party: Abdulrahman Muhammad Rageh, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04241107    
Other Study ID Numbers: Uterine niche repair
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdulrahman Muhammad Rageh, Assiut University:
Cesarean Scar defect