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

February 3, 2020 updated by: Abdulrahman Muhammad Rageh, Assiut University

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy
Time Frame: 3 month postoperative
Number of patients who subject clinical improvement of pre-operative symptoms
3 month postoperative
Post-operative increase in residual myometrial thickness
Time Frame: 3 month postoperative
difference between pre-operative & post-operative residual myometrial thickness
3 month postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of operation
Time Frame: baseline( During operation)
duration from anesthesia till end of operation
baseline( During operation)
Blood loss
Time Frame: baseline( During operation)
estimated blood loss during operation(towels , suction container)
baseline( During operation)
Intra-operative complication
Time Frame: baseline( During operation)
complication during the operation
baseline( During operation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mahmoud Abdel-Aleem, PhD, Assiut University
  • Study Chair: Mahmoud zakhera, PhD, Assiut University
  • Study Chair: Ahmed Abo El Fadle, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uterine niche repair

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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