Duramesh versus conventional suture closure for laparoscopic periumbilical trocar sites Surgery
Conditions
Interventions
TROCAR is a single-centre, parallel arm, randomised controlled trial of Duramesh versus conventional suture, with blinding of patients and outcome assessors at primary outcome assessment. The aim is t
Sponsors
Croydon Health Services NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. 18 years or older. 2. Able to provide written informed consent to participation, without barriers that might prevent follow-up. 3. Any laparoscopic procedure pertaining to the domain of general surgery, requiring periumbilical incision at the linea alba for trocar insertion 10mm or greater. 4. Extraction sites acceptable up to a maximum of 3 cm. 5. Concurrent umbilical hernia if camera port inserted through the defect with subsequent primary repair without planar mesh. 6. Hernia at a remote site from port incisions e.g. concurrent inguinal hernia. 7. Previous abdominal surgery, except for the condition specified in exclusion criteria below.
Exclusion criteria
Exclusion criteria: 1. Lack of capacity to consent to trial participation. 2. Procedures where placement of a periumbilical trocar 40.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative occurrence of trocar-site hernia over 2 years, measured using ultrasound scan at 3 months, 1 year and 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical site occurrence within 90 days measured using physical examination 2. Reoperation within 90 days measured using data collected from patient medical records at one timepoint 3. Mortality within 90 days measured using data collected from patient medical records at one timepoint 4. Length of hospital stay in days measured using data collected from patient medical records at one timepoint 5. Patient reported quality of life (QoL) measured using the Modified EuraHS-QoL score and Modified Carolinas Comfort Scale at 3 months, 1 year and 2 years | — |
Countries
England, United Kingdom
Contacts
Public ContactLawrence Nip
Outcome results
None listed