Gynecological cancer Cancer
Conditions
Interventions
Adult women undergoing surgical treatment because of female genital tract malignancies are included. Patients are randomly assigned to one of the two different groups: Group 1 will receive an applicat
Sponsors
National Medical Institute of the Ministry of the Interior and Administration
Instytut Matki i Dziecka
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Diagnosis (or suspicion) of gynecological malignancy (ovarian, endometrial or cervical cancer) with the qualification for surgical treatment by laparotomy
Exclusion criteria
Exclusion criteria: 1. Allergy for analgesics 2. Viral or bacterial local infections, coagulation disorders 3. Body mass index (BMI) > 40 kg/m2 4. Lack of consent for the study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound dehiscence, defined as both complete and partial wound separation (>1 cm long) diagnosed by the clinician during the follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative pain intensity measured using a Visual Analogue Scale (VAS) immediately after the surgery, 6 and 12 hours after the surgery 2. Analgesic use after surgery in the early postoperative period measured using data collected in patient medical records, defined as the mean and total number of morphine boluses needed, the number of doses of paracetamol, metamizole and ketoprofen needed per one-day 3. Scar quality assessment measured by the Patient and Observer Scar Assessment Scale (POSAS) recorded on days 1, 8, 30 and 90 after surgery by both patient and clinician 4. Quality of life assessment after surgery measured using the 12-Item Short Form Survey (SF-12) on days 1, 8, 30 and 90 after surgery | — |
Countries
Poland
Contacts
Public ContactTadeusz;Katarzyna Issat;Pankiewicz
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Outcome results
None listed