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Posterior Approach for Pectouteropexy

Primary Purpose

Apical Prolapse

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pectouteropexy
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Prolapse focused on measuring pectouteropexy

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Being between 30-60 years of age 2. To be diagnosed with at least Stage 2 apical prolapse 3. To have completed fertility 4. To be treated with pectouteropexy for the prolapse

Exclusion Criteria:

  • 1. Having had previous prolapse surgery 2. To have connective tissue diseases 3. Inable to cooperate

Sites / Locations

    Outcomes

    Primary Outcome Measures

    POP-Q assesment
    pelvic organ prolapse quantification system assessment, does not have any maximum or minimum value, it is scored according to the visualization and is used to assess the difference of prolapse objectively

    Secondary Outcome Measures

    operation satisfaction
    operation satisfaction will be assessed via patient global impression of improvement, it is scaled one to seven, one is related to be satisfied with the result of operation and seven is related to not satisfied from the operation results
    pain scores
    pain scores will be assessed via visual analog scale questionnaire, it is scaled one to ten, one is related to have a little pain and 10 is related to have a lot of pain

    Full Information

    First Posted
    June 25, 2019
    Last Updated
    June 27, 2019
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04002375
    Brief Title
    Posterior Approach for Pectouteropexy
    Official Title
    Posterior Approach for Pectouteropexy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    February 27, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Pectouteropexy surgery has lower complication rates compared to other sling operations. Sacrocolpopexy is another common procedure for hanging the uterus. Small bowel obstruction, ileus or defecation problems are observed in percentages ranging from 0.1 to 5%. Mesh placed between sacrum and vagina often causes narrowing of the pelvis, adhesions may occur and traumas may occur in hypogastic nerves. However, presacral bleeding, which is the most feared complication of these operations, is a rare but life-threatening condition. In pectouteropexy, it is located away from the bladder, intestine and hypogastric vessels by placing the iliopectineal ligament laterally and eliminates the risk of presacral hemorrhage. In pectouteropexy surgery, the mesh is placed anterior to the cervix. The points emphasized in the criticisms about this technique, inadequate support of the posterior compartment mesh placed in anterior in a future pregnancy is a possible cesarean section and the negative effects on the delivery process. Therefore, a new technique of pectouteropexy surgery to the posterior of the cervix instead of the anterior cervix of the cervix, the sacrouterine ligament to reduce the complications that may occur due to this procedure and this study was planned to increase the effectiveness.
    Detailed Description
    The study was planned prospectively. The research is planned to be conducted between 30.06.2019 and 30.12.2019. Study Kartal İstanbul Prof. Dr. Lütfi Kırdar Training and Research Hospital Department of Obstetrics and Gynecology. Under the responsibility of Prof. Dr. Ahmet Kale, it will be conducted by Kazibe Koyuncu. The study was planned as a pilot study since it was planned to investigate the results of performing the surgical method with the posterior approach instead of the anterior approach and it was calculated that the inclusion of 20 patients would be sufficient. It is planned to include 20 patients between 30-60 years of age who applied to hospital with prolapse complaint and completed fertility request. Patients' symptoms and physical examinations will be recorded in accordance with international standards and questionnaires will be applied to the files in order to make objective evaluation before and after surgery. Pre-and post-operative POP-Q classifications will be recorded in the files, PFDI-20 questionnaire evaluating the severity of prolapse before and after the surgery, and PGI questionnaire evaluating postoperative satisfaction. In the pectouteropexy operation we applied to the patients, the support of the uterus posterior was insufficient in the sling fixation with mesh suture to the anterior and iliopectineal ligaments of the uterine cervix. We aimed to increase the efficiency of the operation by hanging the uterine cervix posterolaterale to the iliopectineal ligament with the anterior uterine cervix in order to get better results with this method, which can be applied more safely and easily than the other sling methods. Consent form is attached. There are validity-reliability studies of the questionnaires to be used in Turkish.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apical Prolapse
    Keywords
    pectouteropexy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    pectouteropexy
    Intervention Description
    The surgical procedure was initiated after adhesiolysis had been performed by opening the peritoneal layer along the round ligament toward the pelvic side wall. Preparation started at the right external iliac vein and was performed in the medial and caudal direction. A segment of area approximately 3- 4 cm2 of the right lateral part of the iliopectineal ligament (Cooper ligament) adjacent to the insertion of the iliopsoas muscle was exposed.The peritoneum of the bladder was dissected, and the anterior parts of the distal uterus were prepared for mesh fixation. The uterus was elevated to the intended tension-free position using the transvaginal probe (POP-Q level 0-1). The mesh was fixed anteriorly to the cervix using four polyester permanent sutures (Ethibond Excel®; Ethicon). Finally, the mesh was covered with peritoneum using a continuous monofilament absorbable suture (Maxon™; Medtronic).
    Primary Outcome Measure Information:
    Title
    POP-Q assesment
    Description
    pelvic organ prolapse quantification system assessment, does not have any maximum or minimum value, it is scored according to the visualization and is used to assess the difference of prolapse objectively
    Time Frame
    postoperative 1. day
    Secondary Outcome Measure Information:
    Title
    operation satisfaction
    Description
    operation satisfaction will be assessed via patient global impression of improvement, it is scaled one to seven, one is related to be satisfied with the result of operation and seven is related to not satisfied from the operation results
    Time Frame
    postoperative 1month
    Title
    pain scores
    Description
    pain scores will be assessed via visual analog scale questionnaire, it is scaled one to ten, one is related to have a little pain and 10 is related to have a lot of pain
    Time Frame
    postoperative 1. day

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Being between 30-60 years of age To be diagnosed with at least Stage 2 apical prolapse To have completed fertility
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Being between 30-60 years of age 2. To be diagnosed with at least Stage 2 apical prolapse 3. To have completed fertility 4. To be treated with pectouteropexy for the prolapse Exclusion Criteria: 1. Having had previous prolapse surgery 2. To have connective tissue diseases 3. Inable to cooperate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    kazibe koyuncu, M.D.
    Phone
    00905053728124
    Email
    kazibekkoyuncu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    eda sayar, M.D.
    Phone
    0090 5362141874
    Email
    edasyr@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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