A Starch-Based Gel Barrier Reduces Pain and Improves Fertility After Endometriosis Surgery

The use of gel barrier 4DryField® PH could reduce pain development and improve fertility following endometriosis resection surgery via the prevention of barrier formation.

Key Points

Highlights: 

• The use of barrier gel during endometriosis resection surgery reduces pain development and increases fertility.

Importance:

• This randomized controlled trial advises the use of the gel barrier during resection surgery to treat deep infiltrating endometriosis (DIE).

What’s done here:

• Researchers analyzed the pain scores of 50 patients (25 intervention group, 25 control group) with DIE who underwent resection surgery before the operation.
• One, 6, and 12 months after the surgery pain scores were re-evaluated, and the number of pregnancies following surgery were recorded.

Key results:

• Pain development was reduced in women who received barrier application during DIE resection surgery, 
• The most pronounced reduction was in cycle-independent pelvic pain and dysmenorrhea.
• The pregnancy rate was also significantly higher in these women.

Limitations: 

• The randomized controlled trial was not powered to find significant differences in any of the secondary endpoints discussed here.
• The endpoint “indication for adhesiolysis surgery” has limited explanatory power, as the reason to use adhesiolysis or its outcome were not ascertained.

Lay Summary

The development of pain was reduced in women with endometriosis who underwent surgery for deep infiltrating endometriosis (DIE) resection and the "gel barrier 4DryField® PH" was used during the operation, according to results from a randomized controlled trial. Moreover, fertility was improved. "4DryField® PH" is a starch-based powder that forms a gel when it comes in contact with a saline solution, thereby separating surgical sites as a physical barrier. It can be used during surgery to prevent the formation of adhesions.

The trial was testing the efficacy of the gel barrier in reducing the formation of adhesions following endometriosis resection and showed that the gel barrier led to an 85% adhesion reduction in second-look surgeries. Secondary endpoint data on fertility and pain development were also presented. 

“Considering the known causal link between adhesions and pain, it is apparent that the favorable outcomes in the intervention group are linked to effective adhesion prevention,”  researchers wrote in a report that they published in the Journal of Clinical Medicine. “The significant increase in pregnancies is remarkable.”

A total of 50 women took part in this randomized controlled trial, half were treated with gel and the other half received saline solution. Researchers from the Department for Women's Health, University Hospital Tübingen in Germany led by Dr. Alice Höller recorded the pain scores of the women 1, 6, and 12 months after the operation as well as before the operation. The different subcategories of pain recorded were cycle-independent pelvic pain, dysmenorrhea, dyspareunia, dyschezia, and dysuria. The researchers also recorded the number of pregnancies following the operation.

They found that women in whom gel barrier 4DryField® PH was used during the operation experienced less pain development 12 months after the operation in all 5 subcategories. However, improvements were most pronounced in the cycle-independent pelvic pain and dysmenorrhea. These 2 subcategories had the highest scores before the operation, and therefore, were the most relevant for the patients.

“Cycle-independent pelvic pain recurred in the control group”, the researchers wrote, “while barrier application prevented this”. The rate of pregnancy in these women was also significantly higher.

Adhesions commonly occur following resection surgery to treat endometriosis and are the most common causes of chronic pain and infertility.

Research Source: https://pubmed.ncbi.nlm.nih.gov/37240703/