Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Prolapse, Vaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962075
• Other study ID #: 2765/20-6-2016
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: May 10, 2018

Study information

• Verified date: May 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 10, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• female patient with cystocele of lateral type ( paravaginal defect )

Exclusion Criteria:

• previous retropubic surgery,

• uterine prolapse,

• stress urinary incontinence or

• morbid obesity

Related Conditions & MeSH terms

• Cystocele
• Paravaginal Cystocele
• Prolapse
• Prolapse, Vaginal
• Uterine Prolapse

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	hospital stay	hours needed to keep the patient in hospital post operative	during hospitalization
Primary	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	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
Secondary	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