N80 K66.0 N73.6
Conditions
Interventions
Group 1: Adhesion prevention during surgery is carried out using 4DryField® PH
Group 2: No adhesion prevention with an additional special barrier is carried out, but the standard flushing with saline
Sponsors
PlantTec Medical GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Deep infiltrating endometriosis (DIE) or extensive peritoneal and/ or ovarian endometriosis with indication for second laparoscopy. Consent of treatment with conventional surgical procedure after separate information and written consent to participate in the study.
Exclusion criteria
Exclusion criteria: Pregnant patients, breastfeeding patients, patients with known incompatibility of starch-containing substances, patients that do not undergo resection of endometrial tissue during the first laparoscopy and, therefore, do not require any adhesion prevention treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the time of the second laparascopy the adhesion score (which considers incidence, extent, and severity of adhesions) of patients treated with 4DryField® PH is lower than that of the patients treated with saline solution. The primary endpoint is a direct measure of the test product’s ability to prevent adhesions. Firstly, predilection sites of adhesions (and their extent) are determined using a scoring system based on the scores of the American Fertiliy Society (AFS scores). In the second operation the resulting adhesions are evaluated individually for each area with regard to their severity and extent, also modified from the AFS scores. Finally, quotients are calculated from the extent of the adhesion and the degree of the corresponding predilection site (the maximum value is one as adhesions only form at predilection sites). The quotients are then multiplied by factor 4 to achieve scores in the order of the AFS scores. After product formation with the respective severity score, the obtained products of all organs are added up. The sum is then divided by the number of predilection sites, resulting in the total score. Accordingly, this score has a minimum value of 0 and a maximum value of 16. The entire calculation can be described with the equation under 'Further study documents'. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patients treated with 4DryField® PH have a lower postoperative pain score than patients treated with sodium chloride solution. 2. In patients treated with 4DryField® PH, postoperative wound healing disturbances are less common. 3. In patients treated with 4DryField® PH, infections are less common postpoperatively. 4. In patients treated with 4DryField® PH, abscesses are less common postoperatively. 5. In patients treated with 4DryField® PH, reduced adhesion formation lowers the need for reoperations for adhesiolysis. 6. Patients treated with 4DryField® PH less frequently have to undergo surgery-related reoperations (not including adhesiolysis). 7. In women with wish to conceive and treated with 4DryField® PH, the reduced postoperative adhesion formation leads to an increased frequency of pregnancies. The secondary endpoints regarding frequency of adhesiolysis surgeries and pregnancies are indirect measures for the test product’s capability to prevent adhesions. The secondary endpoint “postoperative pain” also is an indirect measure as adhesion formation is a possible cause of postoperative pain. However, this endpoint does not necessarily correlate directly and can only be determined less robustly. The secondary endpoints regarding incidence of postoperative infections, abscesses, reoperations (other than adhesiolysis), and wound healing disturbances include an expanded issue of the added benefit of the test product and are indirect measures of its supportive effect on wound healing. For the secondary hypotheses data are collected during hospitalization and follow-up. During the hospitalization, abscesses, wound healing disturbances, infections and necessary reoperations are documented. After the second operation patients are interviewed daily regarding cycle-independent pelvic pain (based on a pain score). As part of the follow-up, patients are interviewed by telephone after 1, 6 and 12 months. It is determined if reoperation for adhesiolysis was recomm | — |
Countries
Germany
Contacts
Public ContactBernhard Krämer
Stv. Ärztlicher Direktor Gynäkologie, Department für Frauengesundheit
Outcome results
None listed