Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

March 8, 2023 updated by: Mahmoud Abubakr Negm, Zagazig University

Laparoscopic Excision Versus Combined Hysteroscopic and Laparoscopic Repair Without Excision of Large Cesarean Scar Niche: A Randomized Controlled Trial

Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in more wide defect with high risk of recurrence and cannot be used in large niche with low RMT. In this new Double approach (hysteroscopy and laparoscopy) technique, the benefit of both laparoscopy and hysteroscopy will be attained.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In all patient involved in the study, laparoscopic entry will be done, then adhesiolysis and creation of the bladder flap(dissection of the bladder from the uterine scar) then:

Group (I): Laparoscopic Excision of large cesarean scar niche:

Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.

Group (II): Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche:

The investigators will do the hysteroscopic resection of the niche under laparoscopic guide to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture After suturing, the hysteroscopy will be introduced again to assess the repair The patient will be sent home the day after. They will be followed up after 3 and 6 months.

Checkup of CSD repair:

After 6 month of surgery both groups will be examined using sonohysterography to assess the changes in niche diameters

Core outcome sets:

  • Enlargement of the residual myometrium thickness and reduction of postmenstrual bleeding will be measured at the 3-month and 6-month.
  • Subsequent fertility outcome

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • Egypt
      • Zagazig City, Egypt
        • Recruiting
        • Faculty of medicine
        • Contact:
          • Ahmed Ismail, lecturer Obs & gyn

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

History of cesarean section Postmenstrual and or intermenstrual spotting Large Cesarean scar niche, depth more than 50% of adjacent myometrial thickness (AMT).

Failed medical treatment Signed informed consent.

Exclusion Criteria:

A contraindication for a hysteroscopic niche resection Women with a positive pregnancy test. A contraindication for general or local anaesthesia. Coagulation disorders that lead to higher risks on bleeding or anticoagulant use.

A (suspected) malignancy, endometrial polyps, atypical endometrial cells, cervical dysplasia, hydrosalpinx that may communicate with the uterus.

Adenomyosis or leiomyoma (the International Federation of Gynecology and Obstetrics (FIGO) leiomyomia subclassification system Type 0, 1, 2, 3) or large leiomyomas causing the uterine cavity length to be ≥ 9 cm as examined by transvaginal ultrasound or MRI.

Endocrine disorders that interfere with the menstrual cycle. Irregular menstrual cycle (>35 days or intercycle variation of 2 weeks or more).

Patients who are not willing to conceive before and/or after the hysteroscopic surgery.

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 Excision of Large Cesarean Scar Niche
Procedure: laparoscopic repair of cesarean scar niche
Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.
Other Names:
  • laparoscopic excision of cesarean scar niche
Active Comparator: Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche
Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar niche
Hysteroscopic resection of the niche under laparoscopic guide will be done to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture.
Other Names:
  • Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the residual myometrium thickness
Time Frame: will be measured at the 3-month and 6-month
ultrasound measurement of the residual myometrium will be done
will be measured at the 3-month and 6-month
reduction of postmenstrual bleeding
Time Frame: will be assessed at the 3-month and 6-month
participants will report their perception of the amount of bleeding using a questionnaire
will be assessed at the 3-month and 6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsequent fertility outcome
Time Frame: 1 year
the incidence of subsequent conception following intervention will be recorded
1 year

Collaborators and Investigators

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

Sponsor

Zagazig 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)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CS scar niche repair

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data may be used for another study

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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