Pelvic Organ ProlapseNCT03582410
Different Types of Suture for Sacral Colpopexy
A study testing laparoscopic sacral colpopexy with absorbable suture and laparoscopic sacral colpopexy with non absorbable suture in people with Pelvic Organ Prolapse, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- laparoscopic sacral colpopexy with absorbable suture and laparoscopic sacral colpopexy with non absorbable suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2018to 10 Feb 2020
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Who cannot join
- Age > 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial
This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- laparoscopic sacral colpopexy with absorbable suture, laparoscopic sacral colpopexy with non absorbable suture
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sacral colpopexy with absorbable sutureProcedure or surgery
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
laparoscopic sacral colpopexy with non absorbable sutureProcedure or surgery
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture
| Study group | Role | What they receive |
|---|---|---|
| Absorbable suture | Active comparator | laparoscopic sacral colpopexy with absorbable suture Receives: Procedure: laparoscopic sacral colpopexy with absorbable suture |
| Non absorbable suture | Active comparator | laparoscopic sacral colpopexy with non absorbable suture Receives: Procedure: laparoscopic sacral colpopexy with non absorbable suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with anatomical correction of the prolapse
Anatomical correction of the prolapse evaluated by gynecological visit
Measured: 1 year
Secondary outcomes (3)
rate mesh erosion
Measured: 1 year
long term outcomes
development of nicturia, dysuria, obstructed defecation , urinary incontinence
Measured: 1 year
Rate of recurrence
de novo anterior or central or posterior compartment prolapse
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start10 Jul 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Miulli General Hospital
- Responsible party
- Principal investigator, Maurizio Guido, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582410
- Sponsor's protocol ID
- ospedale regionale F. Miulli
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2018
- Last updated
- 31 Mar 2020
- 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03582410
- Acronym / sponsor ID
- ospedale regionale F. Miulli
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Miulli General Hospital
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Jul 2018 (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 randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable suture | Active comparator | Procedure: laparoscopic sacral colpopexy with absorbable suturelaparoscopic sacral colpopexy with absorbable suture |
| Non absorbable suture | Active comparator | Procedure: laparoscopic sacral colpopexy with non absorbable suturelaparoscopic sacral colpopexy with non absorbable suture |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Key exclusion criteria (3 listed)
- Age > 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
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 sacral colpopexy with absorbable suturelaparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture | Procedure or surgery | Absorbable suture |
| laparoscopic sacral colpopexy with non absorbable suturelaparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture | Procedure or surgery | Non absorbable suture |
Primary outcome
Number of patients with anatomical correction of the prolapse
Time frame: 1 year
Anatomical correction of the prolapse evaluated by gynecological visit
3 secondary outcomes
rate mesh erosion
Time frame: 1 year
long term outcomes
Time frame: 1 year
Rate of recurrence
Time frame: 1 year
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 31 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sacral colpopexy with absorbable suture and laparoscopic sacral colpopexy with non absorbable suture in people with Pelvic Organ Prolapse, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of patients with anatomical correction of the prolapse (time frame: 1 year). 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 31 Mar 2020.