None listed
Conditions
Brief 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.
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 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.
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.
Sponsors
Gold Coast Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
1) Previous or concurrent diagnosis of malignancy 2) Known coagulopathy 3) Known allergy to TISSEEL excipients 4) Concurrent use of alternative haemostatic agents other than TISSEEL during operation
Outcome results
None listed