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NCT01551992 · ClinicalTrials.gov registry record · NA

Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc)

A NA study, sponsored by Kaiser Permanente.

Completed
Registry status
NA
Development phase
32
Enrollment target

NCT01551992: Completed NA study, sponsored by Kaiser Permanente.

NCT01551992 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01551992, a NA study, has completed, sponsored by Kaiser Permanente.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target

Study Summary

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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 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.

Primary Outcome

To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): 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.

Interventions

  • PROCEDURE Quill suture vs. Interrupted suture

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2010-11
Est. Completion 2014-07
Phase NA
Kaiser Permanente

294 total trials

What the finished NCT01551992 record still lists

NCT01551992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Quill suture vs. Interrupted suture is the first listed.

NCT01551992 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01551992 about?

NCT01551992 is a clinical study titled "Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc)". 1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted t...

What is the current status of trial NCT01551992?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2010-11. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01551992?

The interventions under investigation include: Quill suture vs. Interrupted suture (PROCEDURE).

Who is sponsoring clinical trial NCT01551992?

This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01551992's enrollment target sits among peer trials

32 1578th of 2000 higher than 409 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01551992, the US trial registry maintained by the National Library of Medicine. NCT01551992 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.