Pelvic Organ Prolapse
Conditions
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.
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.
Interventions
PROCEDUREAnterior Sacro-Spinous
Anterior Sacro-Spinous
Sponsors
Western Galilee Hospital-Nahariya
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* Pelvic Floor Prolapse \> Gr 2, * Anterior \> Posterior defect, * Apical Supportive Defect
Exclusion criteria
* Active Pelvic Inflammation, * Patient Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Participant flow
Recruitment details
44 patients with significant Pelvic Organ Prolapse requiring mesh reconstruction during 2011-2012
Pre-assignment details
The study patients were retrieved out of the operated patients population during the study period.
Participants by arm
| Arm | Count |
|---|---|
| Anterior Sacro-Spinos Support Anterior Sacro-Spinous Support : | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Anterior Sacro-Spinos Support |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 62.4 years STANDARD_DEVIATION 7.75 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring
Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Sacro-Spinous Support | Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring | 44 participants |
Primary
Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure
Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.
Time frame: one year
Population: occurrence and severity of complication is recorded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Sacro-Spinous Support | Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure | 0 participants |
Primary
The Change With Distance Between the Vaginal Apex and the Introitus
The change with distance measured by centimeters, between the vaginal apex and the introitus
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Anterior Sacro-Spinous Support | The Change With Distance Between the Vaginal Apex and the Introitus | -4.4 centimeters |