CClinicalTrials.gg
Status unknownNCT00988975Updated Oct 2, 2009

Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

An interventional study of Insertion of pelvicol graft in Rectocele, sponsored by Urogynecology Associates, Indiana. Status unknown at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-02.

Sponsored by Urogynecology Associates, Indiana · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.

02

Conditions studied

  • Rectocele

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion criteria

Exclusion Criteria:

  • concomitant colo-rectal procedure
  • allergy to pork
  • any contraindication to laparoscopic sacrocolpopexy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Pelvicol graft

    Procedure: Insertion of pelvicol graft

  • No intervention
    No graft material

    No graft material

Interventions

  • ProcedureInsertion of pelvicol graft

    Pelvicol graft

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What researchers measure

Primary outcomes

  1. Anatomic success of rectocele repair

    Time frame: 6 months

Secondary outcomes

  1. change in patient symptomatology post-operatively

    Time frame: 6 months

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Study locations

2 of 2 sites recruiting
  • Clarian North
    Carmel, Indiana 46032, United States
    • Douglass S Hale, MD · Principal investigator
    Recruiting
  • Clarian Methodist
    Indianapolis, Indiana 46202, United States
    • Douglass S Hale, MD · Principal investigator
    Recruiting
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Registry details

Key details

Study ID
NCT00988975
Lead sponsor
Urogynecology Associates, Indiana
First posted
Oct 2, 2009
Start date
Sep 2009
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 2, 2009

Study contacts

Douglass S Hale, MD
Contact
dhale@clarian.org
317-962-6600

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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