ProlapseQuill RALSCNCT01608568
Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy
A study testing Device is the type of suture used: Quill suture vs. Interrupted suture in people with Prolapse, run by University of California, San Diego at 1 site in United States.
Trial summary
1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse
- What is being tested?
- Device is the type of suture used: Quill suture vs. Interrupted suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 2013
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- Undergoing RALSC with or without other procedures for pelvic organ prolapse or incontinence
- Willing to return for follow-up visits
- Written informed consent obtained from each subject
- Must be having a robotic assisted laparoscopic sacrocolpopexy
Who cannot join
- Decline to participate
- Pregnant or contemplating future pregnancy
- Unable to participate in the informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92037
Cara Grimes, MD, 858-657-8737, cgrimes@ucsd.edu
Jasmine Tan-Kim, MD, 619-221-6200, jstan@ucsd.edu
About this study
Official title: AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL
1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.
Read more
2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.
2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.
- Conditions
- Prolapse
- Being tested
- Device is the type of suture used: Quill suture vs. Interrupted suture
- Keywords
- Sutures, Pelvic Organ Prolapse, Sacrocolpopexy, Robotic Assisted Laparoscopy
- Medical subject headings
- Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device is the type of suture used: Quill suture vs. Interrupted sutureDevice
Also called (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) (PDS II™, Ethicon, Somerville, NJ, USA)
To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
| Study group | Role | What they receive |
|---|---|---|
| Interrupted suture | Active comparator | interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA) Receives: Device: Device is the type of suture used: Quill suture vs. Interrupted suture |
| Quill suture | Active comparator | self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) Receives: Device: Device is the type of suture used: Quill suture vs. Interrupted suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh attachment interval
To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA)in terms of time.
Measured: Intraoperative placement of mesh - approximately 30 minutes to 2 hours
Secondary outcomes (1)
Anatomic outcomes using the two suture types
To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). We will also assess mesh erosion rates, costs, and surgeon satisfaction rates.
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startNov 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasmine Tan-Kim, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608568
- Sponsor's protocol ID
- Robotic Sacrocolpopexy Quill
- Acronym
- Quill RALSC
- Status last verified
- May 2012
- First submitted
- 29 Feb 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan-Kim J, Nager CW, Grimes CL, Luber KM, Lukacz ES, Brown HW, Ferrante KL, Dyer KY, Kirby AC, Menefee SA. A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Int Urogynecol J. 2015 May;26(5):649-56. doi: 10.1007/s00192-014-2566-8. Epub 2014 Nov 25.
PubMed 25421934
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AFFIXING POLYPROPYLENE MESH USING BARBED SUTURE (QUILL™ SRS) DURING ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01608568
- Acronym / sponsor ID
- Quill RALSC / Robotic Sacrocolpopexy Quill
- Conditions
- Prolapse
- Keywords
- Sutures, Pelvic Organ Prolapse, Sacrocolpopexy, Robotic Assisted Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 31 May 2012 (estimated)
- 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.
1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates.
2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
2.2.b. Failure rates and mesh erosion rates for each technique will be equally low.
2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted suture | Active comparator | Device: Device is the type of suture used: Quill suture vs. Interrupted sutureinterrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA) |
| Quill suture | Active comparator | Device: Device is the type of suture used: Quill suture vs. Interrupted sutureself-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- Undergoing RALSC with or without other procedures for pelvic organ prolapse or incontinence
- Willing to return for follow-up visits
- Written informed consent obtained from each subject
- Must be having a robotic assisted laparoscopic sacrocolpopexy
Key exclusion criteria (3 listed)
- Decline to participate
- Pregnant or contemplating future pregnancy
- Unable to participate in the informed consent process
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 |
|---|---|---|
| Device is the type of suture used: Quill suture vs. Interrupted sutureAlso: (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) (PDS II™, Ethicon, Somerville, NJ, USA)To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). | Device | Interrupted suture, Quill suture |
Primary outcome
Mesh attachment interval
Time frame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours
To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA)in terms of time.
1 secondary outcome
Anatomic outcomes using the two suture types
Time frame: 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Derived from this study: PubMed 25421934Tan-Kim J, Nager CW, Grimes CL, Luber KM, Lukacz ES, Brown HW, Ferrante KL, Dyer KY, Kirby AC, Menefee SA. A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Int Urogynecol J. 2015 May;26(5):649-56. doi: 10.1007/s00192-014-2566-8. Epub 2014 Nov 25.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device is the type of suture used: Quill suture vs. Interrupted suture in people with Prolapse, run by University of California, San Diego at 1 site in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2012. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesh attachment interval (time frame: Intraoperative placement of mesh - approximately 30 minutes to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608568, which also lists 1 linked publication.
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 1 Jun 2012.