Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBrno University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients requesting uterine preservation
Patients with previous hysterectomy
Patients with premalignancy or malignancy of the female reproductive organs
Concomitant urethropexy
Trial design
Design model
Parallel
Treatments tested in this trial
cyanoacrylate tissue adhesive beside sutures
Procedure/SurgeryA 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.
Suture
Procedure/SurgeryA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Glue mesh fixationExperimental treatment 1 intervention
Group B: Standard Care (Control):Active comparator 1 intervention
Trial outcomes
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.
Time frame
Enrollment to surgery: 4-8 weeksSecondary outcomes
1
Total mesh fixation time
The total time (in minutes) required to manipulate the implant - from its insertion into the abdominal cavity to its fixation to the promontory (including fixation to the cervix and vaginal walls). The total time required for implant fixation between the two groups will be analyzed.
Time frame
Enrollment to surgery: 4-8 weeks2
Total time of the operation
The total operative time (in minutes) is defined as the interval from the initial placement of all laparoscopic trocars to their subsequent removal. A statistical evaluation will be conducted to compare the total time required to complete the surgical procedure between the two groups.
Time frame
Enrollment to surgery: 4-8 weeks3
Peri- and post-operative complications
All perioperative and all postoperative complications will be monitored. The severity of postoperative complications will be assessed according to the Clavien-Dindo classification.
Time frame
From surgery to 12 months4
Perioperative pain intensity and analgetic utilization
All patients will receive analgesics during the postoperative period in accordance with the prevailing therapeutic protocol at the Gynecology and Obstetrics Clinic of the University Hospital Brno. The intensity of pain experienced by patients in the postoperative period will be documented using the Visual Analogue Scale (VAS 0-10) at 6, 24, and 48 hours following surgery. Furthermore, the necessity for opioid analgesics to manage pain will be documented. Subsequent analyses will compare the two groups with respect to the necessity of analgesic and opioid analgesic utilization in the early postoperative period.
Time frame
intervals: 6, 24 and 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov