N80
Conditions
Interventions
Group 1: Adhesion prevention is performed using 4DryField® PH. The patient has an endometriosis resection. At the end of the intervention, the product is applied as a gel. The treatment takes few minu
Sponsors
Albertinen Krankenhaus Hamburg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Laparoscopic endometriosis resection - Written consent to participate in the study - Pre-operative pain = 5 on a numeric rating scale (0-10) for total pain
Exclusion criteria
Exclusion criteria: - Starch intolerability - Conversion from laparoscopy to laparotomy - Additional gynecological or visceral surgical intervention within the follow-up period and without treatment according to the study arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of total pain 12 months after surgery relative to the pre-operative value | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain in categories (cycle independent abdominal pain, dysmenorrhea, dyspareunia, dyschezia, and dysuria), at further time points (3 and 6 months) and as absolute values, respectively - Sort, amount and frequency of analgetics use - Quality of life (via SF-36 and EHP5 questionnaires) - Rates of complications (infections, wound healing disturbances, abscesses or further complications) - Fertility rate (in the subgroup of patients with wish to conceive) - Rate of endometrioma and endometriosis relapse development - Adhesion score (in the subgroup of patients with further interventions) - Rate of patients with intestinal obstructions - Subjective patient satisfaction | — |
Countries
Germany
Contacts
Public ContactRüdiger Klapdor
Albertinen Krankenhaus Hamburg
Outcome results
None listed