Prolapse, VaginalNCT03962075
Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects
A study testing laparoscopic paravaginal repair in people with Prolapse, Vaginal and Paravaginal Cystocele, run by Zagazig University.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Prolapse, Vaginal, Paravaginal Cystocele
- What is being tested?
- laparoscopic paravaginal repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patient with cystocele of lateral type ( paravaginal defect )
Who cannot join
- previous retropubic surgery,
- uterine prolapse,
- stress urinary incontinence or
- morbid obesity
About this study
Official title: Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects: A Clinical Trial
this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.
Read the 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 .
- Conditions
- Prolapse, Vaginal, Paravaginal Cystocele
- Being tested
- laparoscopic paravaginal repair
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic paravaginal repairProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: laparoscopic paravaginal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
time needed for the procedure to be completed
Measured: insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope
intraoperative blood loss
amount of bleeding during the procedure
Measured: 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).
Measured: start after patient recovery from anaesthesia - ends after 12 hours
post-operative hematuria
visible red or brown discoloration of urine .
Measured: 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
Measured: during hospitalization
fever
body temperature 38 Celsius or above
Measured: 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
assessment of the anterior vaginal wall using:Pelvic Organ Prolapse Quantification System .
Measured: 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
abnormal urinary symptoms: ( inability to urinate voluntary- pain during micturition - involuntary escape of urine )
Measured: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Aug 2016
- Primary completion20 Feb 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse, VaginalStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hossam mohamed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962075
- Sponsor's protocol ID
- 2765/20-6-2016
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03962075
- Acronym / sponsor ID
- 2765/20-6-2016
- Conditions
- Prolapse, Vaginal, Paravaginal Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic paravaginal repair | Other | Procedure: laparoscopic paravaginal repairpatient 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female patient with cystocele of lateral type ( paravaginal defect )
Key exclusion criteria (4 listed)
- previous retropubic surgery,
- uterine prolapse,
- stress urinary incontinence or
- morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic paravaginal repairUsing 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 | Procedure or surgery | laparoscopic paravaginal repair |
Primary outcome
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).
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 .
hospital stay
Time frame: during hospitalization
hours needed to keep the patient in hospital post operative
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
2 secondary outcomes
post-operative vaginal wall prolapse
Time frame: 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
Time frame: starts one week following the procedure - three months after the procedure - six months after the procedure -ends one year after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic paravaginal repair in people with Prolapse, Vaginal and Paravaginal Cystocele, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: insertion of the primary tracer ( umbilical trocar )-during the procedure - ends with removing camera telescope). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.