Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects: A Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 50
- Primary Endpoint
- post-operative hematuria
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •female patient with cystocele of lateral type ( paravaginal defect )
Exclusion Criteria
- •previous retropubic surgery,
- •uterine prolapse,
- •stress urinary incontinence or
- •morbid obesity
Arms & Interventions
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
Intervention: laparoscopic paravaginal repair (Procedure)
Outcomes
Primary Outcomes
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 .
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
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
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
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).
hospital stay
Time Frame: during hospitalization
hours needed to keep the patient in hospital post operative
Secondary Outcomes
- 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)
- 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)
Investigators
Hossam mohamed
principal investigator
Zagazig University