Clinical trial NCT06872983: Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
Official title: Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Prolapse
Sacrocolpopexy
Glue Fixation
Keywords: laparoscopic sacrocolpopexy
Tissue Adhesive
Surgical Glue
cyanoacrylate glue
implant fixation
mesh fixation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The duration of fixation of the implant to the walls of the vagina with the adhesive in comparison to the standard suture.
timeFrame: Enrollment to surgery: 4-8 weeks
Secondary outcomes:
measure: Total mesh fixation time
timeFrame: Enrollment to surgery: 4-8 weeks
measure: Total time of the operation
timeFrame: Enrollment to surgery: 4-8 weeks
measure: Peri- and post-operative complications
timeFrame: From surgery to 12 months
measure: Perioperative pain intensity and analgetic utilization
timeFrame: intervals: 6, 24 and 48 hours after surgery
measure: Recurrence rate of pelvic organ prolapse
timeFrame: 6 to 12 months
measure: The degree of bother and distress caused by pelvic floor symptoms.
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: The impact of a floor dysfunction on the quality of life
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: Quality of life of women with urinary incontinence
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: Sexual function evaluation
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: The patient's subjective impression of improvement since surgery
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: Position of the implant
timeFrame: change from baseline to 8-12 weeks, 6 and 12 months
measure: Mesh related complications
timeFrame: From surgery to 12 months
measure: Total cost of care using adhesive fixation versus standard laparoscopic intracorporeal suturing
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: Czech Republic
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital Brno, Brno, Czech Republic
name: Samuel Tvarozek, MD
role: PRINCIPAL_INVESTIGATOR
References: