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Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03962075
Enrollment
50
Registered
2019-05-23
Start date
2016-08-01
Completion date
2018-05-10
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paravaginal Cystocele, Prolapse, Vaginal

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 .

Interventions

PROCEDURElaparoscopic 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

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
feverstarts after shifting the patient from the recovery room to inpatient ward - end 24 hours after shifting the patientbody temperature 38 Celsius or above
post-operative hematuriastarts observation of urine 1hour after end of operation - ends 24 hours after the starting observationvisible red or brown discoloration of urine .
hospital stayduring hospitalizationhours needed to keep the patient in hospital post operative
operative timeinsertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescopetime needed for the procedure to be completed
intraoperative blood lossstart with dissection or retropubic space - during the procedure -ends with removing the camera telescope at the end of operationamount of bleeding during the procedure
post-operative pain: Faces Pain Scalestart after patient recovery from anaesthesia - ends after 12 hoursassessment 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).

Secondary

MeasureTime frameDescription
post-operative abnormal urinary symptomsstarts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedureabnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine )
post-operative vaginal wall prolapsestarts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedureassessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System .

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026