Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

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

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

Study Overview

• Status: Completed
• Conditions: Prolapse, Vaginal; Paravaginal Cystocele
• Intervention / Treatment: Procedure: laparoscopic paravaginal repair

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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

Procedure: laparoscopic paravaginal repair; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): February 20, 2018
• Study Completion (ACTUAL): May 10, 2018

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (ACTUAL): May 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Cystocele; Uterine Prolapse
• Other Study ID Numbers: 2765/20-6-2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No