Adult patients (age 18 years and above) undergoing general or colorectal surgical procedures using any type of abdominal incision measuring at least 5 cm (including extraction sites) Surgery
Conditions
Interventions
Patients will receive quality of life questionnaires at 30-days, 60-days, 90-days, 6-months and 1-year after the date of surgery.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (age 18 years and above) undergoing general or colorectal surgical procedures 2. Elective (planned admission), expedited (within two weeks), or emergency (unplanned admission) surgery 3. General and colorectal procedures using any type of abdominal incision measuring at least 5 cm (including extraction sites) 4. Able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients undergoing incisional, ventral, umbilical, and inguinal/femoral hernia repair 2. Simultaneous hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery 3. Stoma reversal without additional laparotomy incision 4. Anyone who does not have an email address or who does not have access to the internet or a smart device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient, disease, and operation-related factors are measured using patient medical notes at baseline (time of surgery) 2. Wound closure techniques are measured using patient medical notes at baseline (time of surgery) 3. Surgical site infection (SSI) prevention measures are measured using patient medical notes at baseline (time of surgery) 4. Wound healing is measured using the Bluebelle Wound Healing Questionnaire at 30, 60, and 90 days, and 6 and 12 months post-operation 5. Post-operative recovery and return to normal activities are measured using the Patient-Reported Wound Recovery PROM at 30, 60, and 90 days, and 6 and 12 months post-operation 6. Hospital re-admissions are measured using patient medical records at 30, 60, and 90 days, and 6 and 12 months post-operation 7. Re-operations are measured using patient medical records at 30, 60, and 90 days, and 6 and 12 months post-operation 8. Incisional hernia occurrence is measured using the ESCP Incisional Hernia PROM at 12 months post-operation 9. Patient quality of life is measured using the EQ-5D at 30, 60, and 90 days, and 6 and 12 months post-operation 10. Patient quality of life related to wound healing is measured using the Bluebelle Wound Healing Questionnaire at 30, 60, and 90 days, and 6 and 12 months post-operation 11. Patient quality of life related to wound recovery is measured using the Patient-Reported Wound Recovery PROM at 30, 60, and 90 days, and 6 and 12 months post-operation 12. Patient quality of life related to hernia symptoms is measured using the HerQles Questionnaire at 6 and 12 months post-operation 13. Patient-reported incisional hernia occurrence is measured using the ESCP Incisional Hernia PROM at 12 months post-operation 14. Comparison of quality of life for patients with and without wound healing issues and/or incisional hernia is measured using EQ-5D, Bluebelle Wound Healing Questionnaire, Patient-Reported Wound Recovery PROM, HerQles Questionnaire, and ESCP Incisional Hernia PRO | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician-derived surgical outcomes data for up to 30 days post-operation | — |
Countries
Belgium, Denmark, England, Germany, Greece, India, Ireland, Italy, Netherlands, Spain, Sri Lanka, United Kingdom
Contacts
Public ContactJames Keatley
Outcome results
None listed