Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Prolapse, Vaginal, Paravaginal Cystocele

Intervention / Treatment
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* Procedure: laparoscopic paravaginal repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patient with cystocele of lateral type ( paravaginal defect ) Exclusion Criteria: previous retropubic surgery, uterine prolapse, stress urinary incontinence or morbid obesity

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laparoscopic paravaginal repair<br>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 | Procedure: laparoscopic paravaginal repair<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | time needed for the procedure to be completed | insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope | 
| intraoperative blood loss | amount of bleeding during the procedure | start with dissection or retropubic space - during the procedure -ends with removing the camera telescope at the end of operation | 
| 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). | start after patient recovery from anaesthesia - ends after 12 hours | 
| post-operative hematuria | visible red or brown discoloration of urine . | starts observation of urine 1hour after end of operation - ends 24 hours after the starting observation | 
| hospital stay | hours needed to keep the patient in hospital post operative | during hospitalization | 
| fever | body temperature 38 Celsius or above | starts after shifting the patient from the recovery room to inpatient ward - end 24 hours after shifting the patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative vaginal wall prolapse | assessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System . | starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure | 
| post-operative abnormal urinary symptoms | abnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine ) | starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure |