Pectopexy for Apical Prolapse Management

NCT ID: NCT06369857

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2025-08-31

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pectopexy

Intervention Type: PROCEDURE

Suspension of apical organs

Interventions

Pectopexy

Suspension of apical organs

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Gamal M.fekry

Lecturer of Obs& Gyn. Specialist of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Fekry, PhD

Role: CONTACT

mohamedbeethoven2040@gmail.com

0882312388

Facility Contacts

Mohamed Fekry, PhD

Role: primary

Other Identifiers

PPY

Identifier Type: -

Identifier Source: org_study_id