Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField® PH: Follow-up of a Randomized Controlled Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Collection of Follow-up Data
2.3. Statistical Evaluation
3. Results
3.1. Reproductive Outcome
3.2. Pain Development
3.3. Complications
4. Discussion
4.1. Main Findings
4.2. Strengths and Limitations
4.3. Comparison with Other Studies
4.3.1. Relationship between Pain and Endometriosis
4.3.2. Relationship between Pain and Adhesions
4.3.3. Relationship between Fertility and Endometriosis/Adhesions
4.4. Clinical Implications
5. Conclusions and Outlook
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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4DryField Group | Control | ||||
---|---|---|---|---|---|
Mean | SD | Mean | SD | ||
Cycle-independent pelvic pain | Prior to 1st surgery | 4.5 | 3.3 | 4.6 | 3.5 |
Prior to 2nd surgery | 3.4 | 2.7 | 3.4 | 3.3 | |
After 1 month | 2.1 | 2.4 | 2.4 | 2.5 | |
After 6 months | 1.8 | 2.1 | 2.3 | 2.8 | |
After 12 months | 2.0 | 2.3 | 3.4 | 3.2 | |
Dysmenorrhea | Prior to 1st surgery | 8.2 | 2.2 | 7.6 | 2.5 |
Prior to 2nd surgery | 7.2 | 3.1 | 6.0 | 3.6 | |
After 1 month | 5.7 | 3.1 | 5.9 | 3.7 | |
After 6 months | 3.6 | 2.9 | 5.1 | 3.0 | |
After 12 months | 3.9 | 3.6 | 5.1 | 3.5 | |
Dyspareunia | Prior to 1st surgery | 3.0 | 3.0 | 3.3 | 3.4 |
Prior to 2nd surgery | 2.3 | 2.6 | 3.0 | 3.2 | |
After 1 month | 2.0 | 2.7 | 0.6 | 1.4 | |
After 6 months | 1.7 | 2.8 | 1.7 | 2.4 | |
After 12 months | 2.2 | 2.6 | 2.3 | 2.5 | |
Dyschezia | Prior to 1st surgery | 2.0 | 3.0 | 1.7 | 3.0 |
Prior to 2nd surgery | 2.2 | 3.2 | 2.0 | 3.3 | |
After 1 month | 1.2 | 1.8 | 0.8 | 2.2 | |
After 6 months | 0.8 | 2.0 | 1.2 | 2.5 | |
After 12 months | 1.2 | 2.0 | 1.6 | 2.8 | |
Dysuria | Prior to 1st surgery | 1.5 | 2.4 | 0.6 | 1.6 |
Prior to 2nd surgery | 1.0 | 2.4 | 0.9 | 2.2 | |
After 1 month | 0.5 | 1.0 | 1.0 | 2.3 | |
After 6 months | 0.2 | 0.6 | 0.5 | 1.7 | |
After 12 months | 0.9 | 2.1 | 1.6 | 3.1 |
(a) CIPP | 4DryField | Control | p |
Prior to 1st surgery | 4.5 | 4.6 | 0.9835 |
After 12 months | 2.0 | 3.4 | 0.0932 |
p | 0.0024 * | 0.1413 | |
(b) Dysmenorrhea | 4DryField | Control | p |
Prior to 1st surgery | 8.2 | 7.6 | 0.32 |
After 12 months | 3.9 | 5.1 | 0.2525 |
p | <0.0001 * | 0.0009 * | |
(c) Dyspareunia | 4DryField | Control | p |
Prior to 1st surgery | 3.0 | 3.3 | 0.7693 |
After 12 months | 2.2 | 2.3 | 0.977 |
p | 0.0239 * | 0.1761 | |
(d) Dyschezia | 4DryField | Control | p |
Prior to 1st surgery | 2.0 | 1.7 | 0.7347 |
After 12 months | 1.2 | 1.6 | 0.5715 |
p | 0.1816 | 0.4062 | |
(e) Dysuria | 4DryField | Control | p |
Prior to 1st surgery | 1.5 | 0.6 | 0.0873 |
After 12 months | 0.9 | 1.6 | 0.7586 |
p | 0.2422 | 0.2969 |
Our Control Group | Healey et al. [15] | |||
---|---|---|---|---|
Improvement | SD | Improvement | SD | |
CIPP | 1.2 | 3.7 | 2.6 | 3.5 |
Dysmenorrhea | 2.6 | 2.5 | 2.4 | 3.9 |
Dyschezia | 0.9 | 2.7 | 1.8 | 3.5 |
Dysuria | 0.4 | 2.7 | 0.4 | 2.3 |
Dyspareunia | −0.9 | 2.9 | 3.1 | 4.1 |
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Krämer, B.; Andress, J.; Neis, F.; Hoffmann, S.; Brucker, S.; Kommoss, S.; Höller, A. Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField® PH: Follow-up of a Randomized Controlled Clinical Trial. J. Clin. Med. 2023, 12, 3597. https://doi.org/10.3390/jcm12103597
Krämer B, Andress J, Neis F, Hoffmann S, Brucker S, Kommoss S, Höller A. Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField® PH: Follow-up of a Randomized Controlled Clinical Trial. Journal of Clinical Medicine. 2023; 12(10):3597. https://doi.org/10.3390/jcm12103597
Chicago/Turabian StyleKrämer, Bernhard, Jürgen Andress, Felix Neis, Sascha Hoffmann, Sara Brucker, Stefan Kommoss, and Alice Höller. 2023. "Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField® PH: Follow-up of a Randomized Controlled Clinical Trial" Journal of Clinical Medicine 12, no. 10: 3597. https://doi.org/10.3390/jcm12103597