Clinical trial NCT03962075: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse, Vaginal
Paravaginal Cystocele
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-05-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: operative time
timeFrame: insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope
measure: intraoperative blood loss
timeFrame: start with dissection or retropubic space - during the procedure -ends with removing the camera telescope at the end of operation
measure: post-operative pain: Faces Pain Scale
timeFrame: start after patient recovery from anaesthesia - ends after 12 hours
measure: post-operative hematuria
timeFrame: starts observation of urine 1hour after end of operation - ends 24 hours after the starting observation
measure: hospital stay
timeFrame: during hospitalization
measure: fever
timeFrame: starts after shifting the patient from the recovery room to inpatient ward - end 24 hours after shifting the patient
Secondary outcomes:
measure: post-operative vaginal wall prolapse
timeFrame: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure
measure: post-operative abnormal urinary symptoms
timeFrame: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure
Other outcomes:
Locations:
Study officials:
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