Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

NCT03962075 | Completed

• 1 other identifier: 2765/20-6-2016
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prolapse, Vaginal; Paravaginal Cystocele

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (1)

laparoscopic paravaginal repair

OTHER

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

Interventions

laparoscopic paravaginal repair PROCEDURE

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

laparoscopic paravaginal repair

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: female patient complaining of anterior vaginal wall prolapse of lateral type
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• previous retropubic surgery,
• uterine prolapse,
• stress urinary incontinence or
• morbid obesity

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 23, 2019
• Study Start: August 1, 2016
• Primary Completion: February 20, 2018
• Study Completion: May 10, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05