Pectopexy for Apical Prolapse Management

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Pectopexy

• Registration Number: NCT06369857
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Status Verified: 2024-05
• Study Start: 2024-05-09
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-02
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pectopexy	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

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification stage	6 , 12 months	Stage 0 to stage 4

Secondary Outcome Measures

Name	Time	Method
Bladder neck measurements using Transperineal US	6 , 12 months	Bladder neck height in millimeters
Urinary Symptoms questionnaire	6 , 12 months months	Questions about urinary system before and after surgery

Trial Locations

Locations (1)

Women Health Hospital; 🇪🇬 Assiut, Egypt