Adhesion prevention after endometriosis surgery — results of a randomized, controlled clinical trial with second-look laparoscopy

Abstract

Purpose Adhesion formation after endometriosis surgery is a severe problem affecting up to 90% of patients. Possible complications include chronic pain, ileus, and secondary infertility. Therefore, effective adhesion prophylaxis is desirable, for which the adhesion barrier 4DryField® PH is evaluated in the present clinical study. It is a starch-based powder that forms a gel after irrigation with saline solution and thus separates surgical sites as physical barrier for adhesion prevention. Methods Fifty patients with extensive and deep infiltrating endometriosis were included in this prospective, randomized, controlled clinical trial with two-staged laparoscopic approach. The patients were randomized into two groups, one receiving 4DryField® PH and the other irrigation with saline solution for adhesion prevention. Adhesion formation was directly scored during second-look interventions considering incidence, extent, and severity. Adhesion prevention treatment in the second surgery was performed corresponding to the first intervention to evaluate the long-term outcome in the later course. Results Both groups were comparable with respect to relevant patient parameters. Severity and extent of adhesions were significantly reduced by 85% in the 4DryField® PH group compared to the control group (mean total adhesion score 2.2 vs. 14.2; p = 0.004). Incidence of adhesion formation based on the number of affected sites was significantly reduced by 53% in the intervention vs. control group (mean 1.1 vs. 2.3 sites; p = 0.004). Follow-up of secondary endpoints is not yet completed; results will become available at a later stage. Conclusion Adhesion formation could be reduced significantly by 85% by application of the adhesion barrier 4DryField® PH. Trial registration Trial registration main ID: DRKS00014720, secondary ID: U1111-1213-4142; date of registration 09th May 2018.

Postsurgical adhesion formation score pitfalls in endometriosis surgery

“…We read with great attention the well-designed randomized article by Kramer et al which was published in your journal [1]. This study reports the advantages of the adhesion barrier 4DryField® PH in patients following endometriosis surgery.…”

Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField® PH: Follow-up of a Randomized Controlled Clinical Trial

“…Patient collectives and primary endpoint results of our trial are published elsewhere [26]. In summary, both groups were comparable with respect to relevant patient parameters.…”

“…No complications occurred in any of the patients during either hospital stay. Adhesions were assessed during both interventions using the same detailed adhesion score [26]. In both surgeries, 16 previously defined specific areas of interest were evaluated.…”

Using a Modified Polysaccharide as a Hemostatic Agent Results in Less Reduction of the Ovarian Reserve after Laparoscopic Surgery of Ovarian Tumors—Prospective Study

“…Other studies in the field of gynecology and the use of starch mainly concern the prevention of adhesions, which is an undoubted advantage of 4DryField. Kramer et al showed that the use of 4DryField in endometrial cyst surgery reduces the formation of adhesions by 85% [ 43 ]. On the other hand, studies by Ziegler et al showed that it is safe from the risk of inflammation and is good at preventing the formation of adhesions despite the increase in C-reactive protein levels after surgery [ 44 ].…”