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Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?

This study is currently recruiting participants.
Verified June 2012 by Atlantic Health System
Sponsor:
Collaborator:
Reproductive Medicine Associates of New Jersey
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01614587
First received: May 31, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes

May 31, 2012
June 7, 2012
March 2012
December 2012   (final data collection date for primary outcome measure)
SNP microarray analysis from recurrent prolapse subjects and controls [ Time Frame: 12 months post-operative, DNA will be collected ] [ Designated as safety issue: No ]
DNA will be evaluated by a variety of methods. For example, candidate polymorphisms may be evaluated using TaqMan SNP allelic discrimination assays which are based upon duplex real-time PCR. In addition, genome-wide SNP microarrays may be employed in order to perform a whole genome association study. Additional analysis such as DNA resequencing may also be required in order to indentify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.
Same as current
Complete list of historical versions of study NCT01614587 on ClinicalTrials.gov Archive Site
Compare all peri-operative characteristics and demographics between groups [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
Perioperative data will include: age, date of surgery, repeat procedure or treatment, procedure and mesh used, mesh related complications, early post-operative complications. Descriptive statistics will be derived for the entire group. The two subgroups (case and control) will then be compared using: Student t test, Fisher exact test, and Wilcoxon rank-sum test for continuous, nonparametric categorical and nonparametric ordinal variables, respectively.
Same as current
Not Provided
Not Provided
 
Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?

The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.

Pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. Several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. One in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. The correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. There are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. There are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. And a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA obtained from a buccal swab
Probability Sample

Women suffering from pelvic organ prolapse
Pelvic Organ Prolapse
Not Provided
  • Cases
    1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy
    2. The recurrence required treatment (surgery or pessary)
  • Controls
    1. Sacrocolpopexy during the same period
    2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

Exclusion Criteria:

  • Obvious surgical technical failure
  • Use of other graft material than polypropylene mesh
  • Planned two staged operation
  • Contraindications to surgery based on existing medical conditions
  • Pregnancy
  • Desire for pregnancy in the future
Female
Not Provided
No
Contact: Patrick Culligan, MD 973-971-7267
Contact: Richard Scott, MD
United States
 
NCT01614587
R11-10-004
Yes
Jodie Komar, Atlantic Health System
Atlantic Health System
Reproductive Medicine Associates of New Jersey
Principal Investigator: Richard Scott, MD Reproductive Medicine Associates
Principal Investigator: Patrick Culligan, MD Atlantic Health System
Principal Investigator: Charbel Salamon, MD Atlantic Health System
Atlantic Health System
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP