RecruitingACTRN12621000146897

TISSEEL (Fibrin Sealant) for Vaginal Vault Haematoma

Evaluation of the effect of TISSEEL (Fibrin Sealant) on incidence of vaginal vault haematoma post total laparoscopic hysterectomy

Sponsor

Gold Coast Hospital and Health Service

Enrollment

400 participants

Start Date

Feb 1, 2021

Study Type

Interventional

Conditions

Vaginal Vault Haematoma Hysterectomy

Summary

A vaginal vault haematoma formation is a recognised complication of a hysterectomy and can be associated with post-operative infection, bleeding, pain, discharge, ileus, prolonged hospital stay or readmission, or even return to theatre. The aim of this randomised controlled trial is to evaluate the rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. As secondary endpoints the rate of complications associated with a vaginal vault haemotoma post-TLH will be assessed including: re-admission, blood transfusion, vault infection requiring antibiotics, and return to theatre. Participants will include females aged 18 and over undergoing a total laparoscopic hysterectomy for benign pathology on theatre lists at the Gold Coast University Hospital under the supervision of the Gynaecology Director. After consenting, they will be randomly allocated with a 1:1 ratio. If the Director deems the use of TISSEEL is necessary due to the clinical situation then the participants will be excluded from the trial. Participants will be followed up with a phone call questionnaire regarding complications and undergo an ultrasound scan to evaluate for a vault haematoma.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a hysterectomy (surgical removal of the uterus), a small blood collection can sometimes form at the top of the vagina where it was closed off — called a "vaginal vault haematoma." While often minor, this complication can lead to infection, pain, prolonged hospital stay, or even the need for additional procedures. Surgeons are looking for ways to reduce how often this happens. This trial is testing TISSEEL, a fibrin sealant (a type of biological glue made from blood-clotting proteins) that is applied to the surgical site at the end of the operation to help stop minor bleeding. The study compares outcomes between women who receive TISSEEL and those who do not, measuring the rate of haematoma formation on ultrasound scan after surgery. Women aged 18 or older who are having a total laparoscopic hysterectomy (keyhole removal of the uterus) for a non-cancerous condition at Gold Coast University Hospital under a specific gynaecologist are eligible. Women with previous cancer, known clotting disorders, or allergies to TISSEEL ingredients are excluded. After the operation, participants will receive a phone call questionnaire and a follow-up ultrasound scan to check for any haematoma.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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.