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Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Z

Zagazig University

Status

Completed

Conditions

Prolapse, Vaginal
Paravaginal Cystocele

Treatments

Procedure: laparoscopic paravaginal repair

Study type

Interventional

Funder types

Other

Identifiers

NCT03962075
2765/20-6-2016

Details and patient eligibility

About

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

Full 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 .

Enrollment

50 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

laparoscopic paravaginal repair
Other group
Description:
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
Treatment:
Procedure: laparoscopic paravaginal repair

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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