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

NCT06872983 | Recruiting

• 2 other identifiers: 2025069LSCGlueSUp 6/25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

laparoscopic sacrocolpopexy; Tissue Adhesive; Surgical Glue; cyanoacrylate glue; implant fixation; mesh fixation

Outcome Measures

Primary Outcomes (1)

• The duration of fixation of the implant to the walls of the vagina with the adhesive in comparison to the standard suture.

  To determine whether or not the duration of fixation of the implant to the anterior and posterior vaginal walls using adhesive is statistically significantly shorter in minutes compared to standard fixation using sutures. The statistical evaluation will be based on time measured with a stopwatch (minutes). The time is measured from the start of fixation of the implant to the vaginal walls until it is completely anchored to the vaginal walls. This objective does not evaluate the time required for complete fixation of the implant including fixation to the promotorium, but only the time required to fix the implant to the vagina.

  Enrollment to surgery: 4-8 weeks

Secondary Outcomes (13)

• Total mesh fixation time

  Enrollment to surgery: 4-8 weeks

• Total time of the operation

  Enrollment to surgery: 4-8 weeks

• Peri- and post-operative complications

  From surgery to 12 months

• Perioperative pain intensity and analgetic utilization

  intervals: 6, 24 and 48 hours after surgery

• Recurrence rate of pelvic organ prolapse

  6 to 12 months

Study Arms (2)

Glue mesh fixation

EXPERIMENTAL

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

Procedure: cyanoacrylate tissue adhesive beside sutures

Standard Care (Control):

ACTIVE COMPARATOR

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

Procedure: Suture

Interventions

cyanoacrylate tissue adhesive beside sutures 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.

Glue mesh fixation

Suture 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.

Standard Care (Control):

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Cisgender females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, Czech Republic, 62500, Czechia

RECRUITING

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Samuel Tvarozek, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Tvarozek, MD

CONTACT

+420532238207; tvarozek.samuel@fnbrno.cz

Martina Szypulová, MD

CONTACT

+420532233975; szypulova.martina@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CZ (1)