TISSEEL (Fibrin Sealant) for Vaginal Vault Haematoma

Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: TISSEEL (Fibrin sealant) will be used in participants who undergo total laparoscopic hysterectomy with no indication or concern of bleeding post suture of vaginal vault. After suturing of the vaginal vault, with patient still anaesthetised and laparoscopic ports still in situ, a consultant gynaecologist will apply the TISSEEL topically to the vaginal vault suture. Enough TISSEEL will be applied as is sufficient to entirely cover the suture area. TISSEEL will only be applied once per patient. Applying TISSEEL takes about 30‐60 secondss, then requires a 2 minute wait (to check haemostasis +/‐ perform salpingectomy during this time). Patients who consent to the study and undergo intervention will have procedure notes entered into the electronic medical record that will be accessible to the study team for analysis. CONDITION: Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Surgery ‐ Other surgery Vaginal Vault Haematoma;Hysterectomy; ; Vaginal Vault Haematoma ; Hysterectomy PRIMARY OUTCOME: The rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. Participants will be invited to attend a free ultrasound. The presence and dimensions of any vault collection reported on the ultrasound summary will be recorded.[12‐14 days post hysterectomy] SECONDARY OUTCOME: This is a composite outcome. The rate of complications associated with a vaginal vault haematoma post‐TLH within 6 weeks including: gynaecology re‐admission, blood transfusion, vault infection requiring antibiotics, and/or return to theatre. The patient’s hospital records will be reviewed to look for any presentation to the Emergency Department with any complications within the 6 weeks post‐operatively. The patient will be called at 6 weeks post‐operation and a unvalidated tick box questionnaire completed over the phone.[Up to 6 weeks post hysterectomy] INCLUSION CRITERIA: 1) Females 2) 18 years old and over 3) Undergoing a Total Laparoscopic Hysterectomy for benign pathology at Gold Coast University Hospital 4) Operational consultant listed as Dr Walker
Epistemonikos ID: ed929f2a3c05a32e65760285cd247e6e256e9d91
First added on: Aug 24, 2024