Sacro-Spinous Ligaments Anterior Apical Anchoring

• Sponsor: Western Galilee Hospital-Nahariya (Other)
• Overall Status: Completed
• CT.gov ID: NCT01842464
• Collaborator: (none)
• Enrollment: 44
• Duration (Months): 4

Study Details

Study Description

Brief Summary

Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Anterior Sacro-Spinous

Detailed Description

Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Study Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Anterior Sacro-Spinous Support Anterior sacro-spinous mesh implants supported patients	Procedure: Anterior Sacro-Spinous; Anterior Sacro-Spinous

Outcome Measures

Primary Outcome Measures

1. The Change With Distance Between the Vaginal Apex and the Introitus [One year]

   The change with distance measured by centimeters, between the vaginal apex and the introitus

2. Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring [one year]

   Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.

3. Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure [one year]

   Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 95 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pelvic Floor Prolapse > Gr 2,

• Anterior > Posterior defect,

• Apical Supportive Defect

Exclusion Criteria:

• Active Pelvic Inflammation,

• Patient Refusal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Western Galilee Hospital-Nahariya

Investigators

• Principal Investigator: Menahem Neuman, Prof., Western Galilee MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: menahem neuman, Responsible for UroGynecology and Pelvic Floor Medicine, Western Galilee Hospital-Nahariya
• ClinicalTrials.gov Identifier: NCT01842464
• Other Study ID Numbers: WesternGalileeH
• First Posted: Apr 29, 2013
• Last Update Posted: Jun 19, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Recruitment Details	44 patients with significant Pelvic Organ Prolapse requiring mesh reconstruction during 2011-2012
Pre-assignment Detail	The study patients were retrieved out of the operated patients population during the study period.

Arm/Group Title	Anterior Sacro-Spinos Support
Arm/Group Description	Anterior Sacro-Spinous Support :
Period Title: Overall Study
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Anterior Sacro-Spinos Support
Arm/Group Description	Anterior Sacro-Spinous Support :
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	35 79.5%
>=65 years	9 20.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.4 (7.75)
Sex: Female, Male (Count of Participants)
Female	44 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	The Change With Distance Between the Vaginal Apex and the Introitus
Description	The change with distance measured by centimeters, between the vaginal apex and the introitus
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anterior Sacro-Spinous Support
Arm/Group Description	Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
Measure Participants	44
Mean (Full Range) [centimeters]	-4.4

2. Primary Outcome

Title	Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring
Description	Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anterior Sacro-Spinos Support
Arm/Group Description	Anterior Sacro-Spinous Support :
Measure Participants	44
Number [participants]	44 100%

3. Primary Outcome

Title	Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure
Description	Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

occurrence and severity of complication is recorded

Arm/Group Title	Anterior Sacro-Spinos Support
Arm/Group Description	Anterior Sacro-Spinous Support :
Measure Participants	44
Number [participants]	0 0%

Adverse Events

Time Frame	one year
Adverse Event Reporting Description	Urinary tract injury, intestinal injury, nerve injury, bleeding, mesh exposure, infection,
Arm/Group Title	Anterior Sacro-Spinos Support
Arm/Group Description	Anterior Sacro-Spinous Support :
All Cause Mortality
	Anterior Sacro-Spinos Support
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anterior Sacro-Spinos Support
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	Anterior Sacro-Spinos Support
	Affected / at Risk (%)	# Events
Total	0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.