Vaginal Adventitia Reserved and Anatomical Implant Technique of Transvaginal Mesh Procedure for Pelvic Organ Prolapse

Sichuan University

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Study type: Observational

Funder types: Other

Identifiers

NCT05707533

2021833

Details and patient eligibility

About

After obtaining an institutional ethics approval (#2021833), the investigators retrospectively reviewed patients with Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) in their hospital during June 2008 and December 2020. The goal of this observational study is to introduce the Vaginal Adventitia Reserved and Anatomical Implant Technique in Transvaginal mesh surgery, and to report long term efficacy and safety results of this technique. The main questions it aims to answer are:

• How to reduce the potential risk of mesh-related complications when performing TVM?
• How effective is the use of the Vaginal Adventitia Reserved and Anatomical Implant Technique when performing TVM? Participants will be asked to fill the Pelvic Floor Distress Inventory (PFDI-20) at final follow-up, and the Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.

Full description

Patients and materials The investigators retrospective reviewed consecutive patients with stage II to IV Pelvic organ prolapse (POP) who underwent Transvaginal Mesh (TVM) at their center from June 2008 to December 2020. The Vaginal Adventitia Reserved and Anatomical Implant Technique was performed on all patients. Informed consent was obtained from all included patients. Approval was obtained from the institutional ethics committee of our hospital (West China Hospital, Sichuan University).

The pre-cut mesh kits including Gynecare Prolift® (Ethicon, Sommerville, NJ, USA), Perigee (AMS, Minnetonka, MN, USA), and Gynecare Prosima® (Ethicon, Sommerville, NJ, USA) and self-cut mesh Gynemesh (Ethicon, Sommerville, NJ, USA) were applied for transvaginal mesh repair in this study. Surgery was performed by an experienced surgeon (Dr. HS), utilizing the vaginal adventitia reserved and anatomical implant technique.

Outcome measures The effect of operation was assessed using both objective and subjective measures. The objective assessment (anatomic assessment) of success was that the nadir of prolapse never reached the point 0 (the level of hymen). The subjective assessment of success was the absence of prolapse symptoms. Chinese version of the Pelvic Floor Distress Inventory (PFDI-20) was also utilized for assessing the outcomes. Prosthesis/Graft Complication Classification Code was used to record the mesh-related complications.

Data analysis Statistical analysis was performed via the commercially available statistical package (SPSS) 22.0 for Windows (SPSS, Chicago, IL, USA). Categorical variables were represented using frequency and percentages and compared using the chi-square test. Continuous variables in accord with normal distribution were described using means and standard deviations (SDs) and analyzed using the Student's t-test. Statistical significance was defined at P < 0.05.

Enrollment: 589 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 yr
• Clinical diagnosis of pelvic organ prolapse
• Pelvic organ prolapse-quantification (POP-Q) > II stage
• Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Exclusion criteria

• Patients who refused to participate in the study.

Trial design

589 participants in 1 patient group

Patients underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique

Description:

Patients with pelvic organ prolapse who underwent TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique between June 2008 and December 2020

Treatment:

Procedure: TVM using the Vaginal Adventitia Reserved and Anatomical Implant Technique