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Completed

NCT Number: NCT03962075

Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.

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Key information

Conditions

Prolapse, Vaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Paravaginal Cystocele Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

laparoscopic paravaginal repair

Procedure

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 outcomes

  1. operative time

    Time frame: insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope

    time needed for the procedure to be completed

  2. intraoperative blood loss

    Time frame: start with dissection or retropubic space - during the procedure -ends with removing the camera telescope at the end of operation

    amount of bleeding during the procedure

  3. post-operative pain: Faces Pain Scale

    Time frame: start after patient recovery from anaesthesia - ends after 12 hours

    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).

  4. post-operative hematuria

    Time frame: starts observation of urine 1hour after end of operation - ends 24 hours after the starting observation

    visible red or brown discoloration of urine .

  5. hospital stay

    Time frame: during hospitalization

    hours needed to keep the patient in hospital post operative

  6. fever

    Time frame: starts after shifting the patient from the recovery room to inpatient ward - end 24 hours after shifting the patient

    body temperature 38 Celsius or above

Secondary outcomes

  1. post-operative vaginal wall prolapse

    Time frame: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure

    assessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System .

  2. post-operative abnormal urinary symptoms

    Time frame: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure

    abnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine )

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects: A Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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