NCT01586559

Brief Summary

A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

April 25, 2012

Last Update Submit

April 26, 2012

Conditions

Diastasis Recti

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles

    12-41 months

Study Arms (2)

Control group

Nulliparous women

Diastasis

Patients after rectus sheath plication due to diastasis

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with interval after rectus sheath plication

You may qualify if:

  • Women after rectus sheath plication for diastasis recti

You may not qualify if:

  • Abdominal wall defect other then umbilical hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulovka Hospital

Prague, 18 00, Czechia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ondrej Mestak M.D.

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 27, 2012

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

April 1, 2012

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

CZ(1)