Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Not Applicable

Completed

• Conditions: Paravaginal Cystocele; Prolapse, Vaginal
• Interventions: Procedure: laparoscopic paravaginal repair

• Registration Number: NCT03962075
• Lead Sponsor: Zagazig University

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 .

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2018-02-20
• Study Completion: 2018-05-10
• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laparoscopic paravaginal repair	laparoscopic paravaginal repair	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

Primary Outcome Measures

Name	Time	Method
post-operative hematuria	starts observation of urine 1hour after end of operation - ends 24 hours after the starting observation	visible red or brown discoloration of urine .
fever	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
operative time	insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope	time needed for the procedure to be completed
intraoperative blood loss	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
post-operative pain: Faces Pain Scale	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).
hospital stay	during hospitalization	hours needed to keep the patient in hospital post operative

Secondary Outcome Measures

Name	Time	Method
post-operative vaginal wall prolapse	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 .
post-operative abnormal urinary symptoms	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 )