Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh

NCT03053479 | Active Not Recruiting

• 1 other identifier: SAME
• Study Type: interventional
• Target: 462
• Locations: 2 countries
• Sites: 7

Brief Summary

Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial.

Conditions

Pelvic Organ Prolapse

Keywords

surgery; native tissue prolapse repair; laparoscopic sacrocolpopexy; vaginal mesh

Outcome Measures

Primary Outcomes (4)

• Objective cure rate

  absence of pelvic organ prolapse (using the POPQ system - maximal I. stage prolapse)

  2 years

• Number of failures in each group

  failure is defined as pelvic organ prolapse stage II or higher using the POPQ system during the clinical examination, or as a descent 1 cm below the lower edge of pubic bone based on ultrasound examination.

  2 years

• de novo dyspareunia

  new occurence of painful sexual intercourse after the surgery.

  2 years

• mesh related complications

  extrusion rate, pain

  2 years

Secondary Outcomes (11)

• Change of the genital hiatus size

  2 years

• Distance of mesh from the bladder neck

  2 years

• Lowest position of the mesh

  2 years

• ICIQ-UI SF

  2 years

• POP-SS

  2 years

Study Arms (3)

Laparoscopic sacrocolpopexy

EXPERIMENTAL

Laparoscopic sacrocolpopexy will be performed in the following way: Identification of the promontory, dissection of the peritoneum above the promontory and preparation of the ligamentum longitudinale anterior, peritoneum dissection, dissection of the vesicovaginal septum up to the bladder neck, dissection of the rectovaginal septum towards the perineum, application of Y mesh, fixation to the vaginal apex using non-absorbable sutures, and for anterior and posterior vaginal wall absorbable sutures. Fixation of the upper mesh arm to the ligamentum longitudinale anterior using non-absorbable suture, following with complete peritoneum closure above the mesh. The procedure could include salpingo-oophorectomy, supracervical hysterectomy or total hysterectomy (concomitant procedures are not exclusion criteria).

Procedure: Laparoscopic sacrocolpopexy

Transvaginal mesh procedure

EXPERIMENTAL

Hydrodissection of the anterior vaginal wall, midline anterior colporrhaphy, preparation beyond the endopelvic fascia, mesh kit with bilateral fixation to sacrospinous ligaments should be used. The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria).

Procedure: Transvaginal mesh procedure

Amreich-Richter procedure:

EXPERIMENTAL

At least unilateral fixation with non-absorbable suture to sacrospinous ligament (fixation could be performed from the anterior approach). At the time of anterior vaginal wall repair or traditional posterior approach, it is possible to use a device for stich fixation (for example Capio, I- stitch etc). The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria).

Procedure: Amreich-Richter procedure

Interventions

Laparoscopic sacrocolpopexy PROCEDURE

see arm/group descriptions

Laparoscopic sacrocolpopexy

Transvaginal mesh procedure PROCEDURE

see arm/group descriptions

Transvaginal mesh procedure

Amreich-Richter procedure PROCEDURE

see arm/group descriptions

Amreich-Richter procedure:

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over18
• signed informed consent
• symptomatic pelvic organ prolapse stage III or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartments, one at least stage II and the second at least stage III
• presence of at least a unilateral avulsion injury of the puborectalis muscle
• agreement with postoperative follow-up.

You may not qualify if:

• previous pelvic reconstructive surgery with mesh
• isolated posterior compartment prolapse
• previous radiotherapy in true pelvis
• contraindication for one of the planned surgical methods.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (7)

Frýdek-Místek regional hospital

Frýdek-Místek, 73801, Czechia

Location

Faculty of Medicine in Olomouc, Palackeho University

Olomouc, Czechia

Location

Faculty of Medicine in Pilsen, Charles University

Pilsen, 30460, Czechia

Location

General University Hospital, 1st Faculty of Medicine, Charles University

Prague, 12800, Czechia

Location

Hospital Na Bulovce, 1st Faculty of Medicine, Charles University

Prague, 18000, Czechia

Location

Tomas Bata Regional Hospital in Zlin

Zlín, 762 75, Czechia

Location

Louis Pasteur University Hospital Kosice

Košice, 04011, Slovakia

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 15, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); CZ (6)