Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy

NCT ID: NCT06872983

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2027-12-31

Brief Summary

The aim of the study is to evaluate the effect of cyanoacrylate adhesive in laparoscopic sacrocolpopexy, which is the gold standard treatment for apical prolapse. The procedure is predominantly performed using minimally invasive techniques, such as laparoscopic or robotic methods. However, the operative time for this procedure often exceeds 180 minutes due to its technical complexity. Although the experience level of the surgical team can lead to a decrease in operative time, there is a concerning increase in the risk of postoperative complications as the duration of surgery extends. One strategy to mitigate overall operative time is to reduce the fixation time of the implant to the vaginal wall.

Standard fixation involves using several sutures, but alternative fixation methods, including barbed sutures and cyanoacrylate adhesives, may demonstrate a reduction in fixation time. While there are only a few studies available on the use of cyanoacrylate adhesives for implant fixation, they generally indicate that this method is safe and can achieve an objective success rate of over 96% in resolving apical descent. However, the reported operative time using glue varies significantly across studies, ranging from 69 to 173 minutes.

The aim of the current study is to assess the impact of a synthetic cyanoacrylate-based tissue adhesive on various factors, including implant fixation time, overall length of surgery, short- and long-term postoperative complications, risk of prolapse recurrence, and the cost-effectiveness of this method in comparison to traditional laparoscopic sutures. This will be conducted as a randomized prospective monocentric study that includes patients aged 18 to 75 years diagnosed with pelvic organ descent grade 2 or higher. Notably, individuals requiring uterine preservation, having undergone previous hysterectomy, or with precancerous or malignant uterine diseases will be excluded.

The surgical approach will involve fixing the implant to the vaginal wall with cyanoacrylate adhesive in the target group, along with non-absorbable sutures. In contrast, the control group will follow traditional fixation methods using absorbable sutures in addition to non-absorbable ones. The study will evaluate outcomes using various questionnaires, including the POPQ for anatomical effect and PFDI-20 for subjective discomfort, while also assessing postoperative pain through the VAS scale.

Expected results include a targeted reduction in implant fixation time by at least 20 minutes and a comprehensive evaluation of the method's cost-effectiveness based on reports from Brno University Hospital. This study is significant as it represents the first prospective randomized trial to investigate the effects of cyanoacrylate adhesive on operative time and cost-effectiveness compared to conventional suturing in laparoscopic sacrocolpopexy

Conditions

Apical Prolapse; Sacrocolpopexy; Glue Fixation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glue mesh fixation

The mesh will be fixed to the vaginal walls using cyanoacrylate tissue adhesive.

Group Type: EXPERIMENTAL

cyanoacrylate tissue adhesive beside sutures

Intervention Type: PROCEDURE

A supracervical hysterectomy will be performed in the standard manner. Uterine amputation above the cervix will be performed with a monopolar needle or scissors. Concomitant adnexal surgery will be performed according to the presence of adnexa and the patient's request or medical indication.

In this study group, the implant is secured to the vaginal wall with cyanoacrylate tissue adhesive. Fixation of the implant to the cervix and promontory will be identical to the control group.

Standard Care (Control):

The mesh will be fixed to the vaginal walls using a standard absorbable suture.

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: PROCEDURE

A supracervical hysterectomy will be performed in the standard manner. Uterine amputation above the cervix will be performed with a monopolar needle or scissors. Concomitant adnexal surgery will be performed according to the presence of adnexa and the patient's request or medical indication. In this control group, the mesh will be fixed to the cervix with four non-absorbable sutures. In addition, the implant will be fixed to the anterior vaginal wall with four absorbable sutures and to the posterior vaginal wall with four absorbable sutures. The implant will be secured to the promontory with one non-absorbable suture.

Interventions

cyanoacrylate tissue adhesive beside sutures

A supracervical hysterectomy will be performed in the standard manner. Uterine amputation above the cervix will be performed with a monopolar needle or scissors. Concomitant adnexal surgery will be performed according to the presence of adnexa and the patient's request or medical indication.

In this study group, the implant is secured to the vaginal wall with cyanoacrylate tissue adhesive. Fixation of the implant to the cervix and promontory will be identical to the control group.

Intervention Type: PROCEDURE

Suture

A supracervical hysterectomy will be performed in the standard manner. Uterine amputation above the cervix will be performed with a monopolar needle or scissors. Concomitant adnexal surgery will be performed according to the presence of adnexa and the patient's request or medical indication. In this control group, the mesh will be fixed to the cervix with four non-absorbable sutures. In addition, the implant will be fixed to the anterior vaginal wall with four absorbable sutures and to the posterior vaginal wall with four absorbable sutures. The implant will be secured to the promontory with one non-absorbable suture.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Sufficient knowledge of the Czech language
• Pelvic organs prolapse of second stage or higher according to POPQ classification (POPQ ≥ 2)
• Patients indicated for laparoscopic sacropexy - sacrocervicopexy with concomitant supracervical hysterectomy

Exclusion Criteria

• Patients requesting uterine preservation
• Patients with previous hysterectomy
• Patients with premalignancy or malignancy of the female reproductive organs
• Concomitant urethropexy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Samuel Tvarozek

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Tvarozek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, University Hospital Brno, Brno, Czech Republic

Locations

Brno University Hospital

Brno, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Samuel Tvarozek, MD

Role: CONTACT

tvarozek.samuel@fnbrno.cz

+420532238207

Martina Szypulová, MD

Role: CONTACT

szypulova.martina@fnbrno.cz

+420532233975

Facility Contacts

Samuel Tvarožek, MD

Role: primary

tvarozek.samuel@fnbrno.cz

+420532238207

Other Identifiers

SUp 6/25

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025069LSCGlue

Identifier Type: -

Identifier Source: org_study_id