- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06369857
Pectopexy for Apical Prolapse Management
Pectopexy for Treatment of Apical Pelvic Organ Prolapse
This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.
Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pelvic organ prolapse (POP) substantially affects the quality of life (QOL) of women, with a global prevalence of 20% to 65% .Surgery is the major treatment option for patients with POP at POP Quantification (POP-Q) stage ≥II, especially after failure of conservative treatments . Apical pelvic organ prolapse is a common issue in Egypt with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births .
Apical support is the most important factor for the successful outcome of pelvic reconstruction surgery. Apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh . Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse . However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Sacropexy also has a long steep learning curve .
Pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterally.This surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis, with a decreased risk of injury to the adjacent organs. The technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity and/or with difficult access to the promontory . However, adequate evidence to support this surgical option still needs further studies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Apical prolapse Stage 2-4 acc. to POP-Q system
- Uterine preservation or after hysterectomy
- Age > 18 years old.
- Sexually active or not.
Exclusion Criteria:
- Pregnancy or up to 6 months postpartum.
- Current Urinary tract infection proved by urine analysis or urine culture.
- Patient unfit for surgery.
- Previous suspension operations.
- Uncontrolled diabetic patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pectopexy
All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina. Evacuation of the bladder and examination under anesthesia is done. Skin incision through pfannenstiel one then incision of subcutaneous tissue, rectus sheath, separation of recti muscle and opening of parietal peritoneum. A polypropylene mesh (30×30 cm, Ethicon, Inc., Somerville, NJ) is cut to obtain two long arms (15-20 cm long) and a rectangular piece (4-7 cm wide). The mesh is fashioned and fixed over the dissected uterine isthmus and anterior part of the cervix with separated number 1 Prolene and number 1 Vicryl sutures. Peritoneal incision was made from the right round ligament toward the pelvic side wall . The mesh arm is grasped and laterally pulled out So the rectangular part of the mesh will be on the anterior part of the cervix The mesh arms are suspended and sutured to Pectineal liga peritoneum is closed over the mesh |
Suspension of apical organs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic Organ Prolapse Quantification stage
Time Frame: 6 , 12 months
|
Stage 0 to stage 4
|
6 , 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Symptoms questionnaire
Time Frame: 6 , 12 months months
|
Questions about urinary system before and after surgery
|
6 , 12 months months
|
Bladder neck measurements using Transperineal US
Time Frame: 6 , 12 months
|
Bladder neck height in millimeters
|
6 , 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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