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Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Primary Purpose

Prolapse, Vaginal, Paravaginal Cystocele

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic paravaginal repair
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse, Vaginal

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patient with cystocele of lateral type ( paravaginal defect )

Exclusion Criteria:

  • previous retropubic surgery,
  • uterine prolapse,
  • stress urinary incontinence or
  • morbid obesity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    laparoscopic paravaginal repair

    Arm Description

    patient enrolled in this arm were offered laparoscopic paravaginal repair by Using a 10mm laparoscope, video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal technique All cases received diclofenac potassium 100 mg and meperidine hydrochloride 50 mg intramuscular with anesthesia recovery and 12 hours later second dose of diclofenac potassium was given. Also 40-60 mg Enoxaparin was given 6-12 hours postoperatively as subcutaneous injection. Foley's catheter was removed 6 hours postoperative

    Outcomes

    Primary Outcome Measures

    operative time
    time needed for the procedure to be completed
    intraoperative blood loss
    amount of bleeding during the procedure
    post-operative pain: Faces Pain Scale
    assessment of pain using Faces Pain Scale( displaying faces that show how much pain the participant can feel. starting with the face on far left shows no pain as The faces move to the right show more and more pain that ends with the face on the right which shows the worst pain then the participants Point to the face that shows how much they feel pain , Each face has a score 0, 2, 4, 6, 8, or 10, so score "0" = "no pain" and score "10" = "very much pain).
    post-operative hematuria
    visible red or brown discoloration of urine .
    hospital stay
    hours needed to keep the patient in hospital post operative
    fever
    body temperature 38 Celsius or above

    Secondary Outcome Measures

    post-operative vaginal wall prolapse
    assessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System .
    post-operative abnormal urinary symptoms
    abnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine )

    Full Information

    First Posted
    May 7, 2019
    Last Updated
    May 22, 2019
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03962075
    Brief Title
    Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects
    Official Title
    Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects: A Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    February 20, 2018 (Actual)
    Study Completion Date
    May 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.
    Detailed Description
    This prospective interventional study. designed to evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse .fifty participants with cystocele of lateral type offered laparoscopic paravaginal repair. the investigator used a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal . The study evaluated the following outcomes Operative time, intra-operative blood loss, hospital stay , post-operative urinary symptoms, post-operative pain, fever, haematuria, post-operative vaginal wall prolapse .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prolapse, Vaginal, Paravaginal Cystocele

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic paravaginal repair
    Arm Type
    Other
    Arm Description
    patient enrolled in this arm were offered laparoscopic paravaginal repair by Using a 10mm laparoscope, video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal technique All cases received diclofenac potassium 100 mg and meperidine hydrochloride 50 mg intramuscular with anesthesia recovery and 12 hours later second dose of diclofenac potassium was given. Also 40-60 mg Enoxaparin was given 6-12 hours postoperatively as subcutaneous injection. Foley's catheter was removed 6 hours postoperative
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic paravaginal repair
    Intervention Description
    Using a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal technique
    Primary Outcome Measure Information:
    Title
    operative time
    Description
    time needed for the procedure to be completed
    Time Frame
    insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope
    Title
    intraoperative blood loss
    Description
    amount of bleeding during the procedure
    Time Frame
    start with dissection or retropubic space - during the procedure -ends with removing the camera telescope at the end of operation
    Title
    post-operative pain: Faces Pain Scale
    Description
    assessment of pain using Faces Pain Scale( displaying faces that show how much pain the participant can feel. starting with the face on far left shows no pain as The faces move to the right show more and more pain that ends with the face on the right which shows the worst pain then the participants Point to the face that shows how much they feel pain , Each face has a score 0, 2, 4, 6, 8, or 10, so score "0" = "no pain" and score "10" = "very much pain).
    Time Frame
    start after patient recovery from anaesthesia - ends after 12 hours
    Title
    post-operative hematuria
    Description
    visible red or brown discoloration of urine .
    Time Frame
    starts observation of urine 1hour after end of operation - ends 24 hours after the starting observation
    Title
    hospital stay
    Description
    hours needed to keep the patient in hospital post operative
    Time Frame
    during hospitalization
    Title
    fever
    Description
    body temperature 38 Celsius or above
    Time Frame
    starts after shifting the patient from the recovery room to inpatient ward - end 24 hours after shifting the patient
    Secondary Outcome Measure Information:
    Title
    post-operative vaginal wall prolapse
    Description
    assessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System .
    Time Frame
    starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure
    Title
    post-operative abnormal urinary symptoms
    Description
    abnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine )
    Time Frame
    starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    female patient complaining of anterior vaginal wall prolapse of lateral type
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: female patient with cystocele of lateral type ( paravaginal defect ) Exclusion Criteria: previous retropubic surgery, uterine prolapse, stress urinary incontinence or morbid obesity

    12. IPD Sharing Statement

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    Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

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