Groundbreaking clinical trial compares ChitoHem hemostatic powder with traditional electrocautery, revealing significant benefits for patient recovery
Every year, millions of people worldwide undergo surgery for common anorectal conditions like hemorrhoids, fissures, and fistulas. These procedures, while frequent, come with a significant and often dreaded consequence: postoperative pain. The anorectal region is one of the most richly innervated areas of the body, making any surgical intervention particularly painful.
Recent scientific exploration is focusing on a promising alternative: hemostatic powders. These innovative agents work by accelerating the body's natural clotting process without the application of heat 1 .
This article delves into a groundbreaking randomized controlled trial that directly compared a hemostatic powder called ChitoHem with traditional electrocautery. The results could significantly change how surgeons approach these common procedures, offering patients a more comfortable recovery.
Anorectal surgery is a delicate affair. The area is not only highly sensitive but also has a rich blood supply, which is a double-edged sword—essential for healing but prone to bleeding during surgery. Controlling this bleeding is a primary goal for surgeons, as it ensures a clear operating field and prevents complications.
Think of it as a miniature, precise soldering iron that uses high-frequency electrical current to generate heat, burning tissue to seal off bleeding vessels.
ChitoHem is a sterile, absorbable powder made from oxidized regenerated cellulose. Its mechanism is primarily physical.
When poured onto a bleeding site, it acts as a superabsorbent, rapidly pulling water out of the blood, concentrating clotting factors and platelets to accelerate natural clot formation 1 .
The core question: Could this gentler, chemical method match the effectiveness of traditional cautery while improving the patient's experience?
To answer this question definitively, researchers in Iran designed a robust observer-blinded, randomized controlled trial (RCT)—considered the gold standard for clinical evidence. The study was conducted at Hazrat Rasool Hospital and involved 60 patients who were scheduled for anorectal surgery 1 .
Patients were randomly assigned to one of two groups. One group would have their bleeding controlled with the ChitoHem hemostatic powder, and the other with traditional electrocautery.
The study was "observer-blinded," meaning the personnel assessing the outcomes (like pain and comfort) did not know which treatment each patient had received. This prevents bias in evaluating the results.
For patients in the ChitoHem group, the powder was applied directly to the bleeding site using a special applicator, covering the area completely. Light pressure was applied with sterile gauze for two minutes to achieve hemostasis. In the electrocautery group, standard procedures using an electric current to coagulate the vessels were followed 1 .
The time taken to stop the bleeding completely
Measured using a Visual Analog Scale (VAS) from 0-10
Rated by both physicians and patients
The results of the trial presented a fascinating trade-off, ultimately leaning heavily in favor of the hemostatic powder.
The data revealed that electrocautery was faster at stopping bleeding immediately. The mean coagulation time in the cautery group was a swift 1.00 minute, compared to 1.63 minutes in the ChitoHem group. This difference was statistically significant (p<0.001) 1 .
Patients in the ChitoHem group reported significantly less pain. The mean pain score in the recovery room was 3.13 for ChitoHem users versus 5.27 for the cautery group. This substantial difference persisted after patients were moved to the ward 1 .
| Outcome Measure | ChitoHem Group | Electrocautery Group | P-value |
|---|---|---|---|
| Blood Coagulation Time (min) | 1.63 ± 0.76 | 1.00 ± 0.00 | < 0.001 |
| Pain Score (in recovery) | 3.13 ± 1.54 | 5.27 ± 1.89 | < 0.001 |
| Pain Score (in ward) | 3.00 ± 1.23 | 5.50 ± 1.50 | < 0.001 |
| Physician's Satisfaction (0-10) | 8.93 ± 0.25 | 8.67 ± 0.47 | 0.018 |
| Patient's Comfort (0-10) | 9.67 ± 0.47 | 7.00 ± 0.00 | < 0.001 |
Data presented as Mean ± Standard Deviation. Source: 1
The benefits of ChitoHem extended beyond just pain. Both physicians and patients reported higher levels of satisfaction when the powder was used. Surgeons were slightly more satisfied with ChitoHem, but the most striking difference was in patient comfort. Patients in the ChitoHem group rated their comfort at a remarkable 9.67 out of 10, compared to only 7.00 in the cautery group 1 .
Patient Comfort with ChitoHem
Patient Comfort with Electrocautery
The trial's conclusion was clear: while cautery wins on speed, ChitoHem provides a superior overall outcome by significantly reducing pain and improving the recovery experience, without sacrificing effective hemostasis.
The findings of this Iranian study are not isolated. The benefits of hemostatic powders are being observed in other surgical fields as well. For instance, a randomized trial in hysterectomy patients found that ChitoHem was effective in reducing bleeding and led to a lower pain score one month after surgery compared to another hemostatic agent 3 . Another study on tonsillectomies also reported reduced bleeding and analgesic use with a similar approach 6 .
The most significant takeaway for patients. Less pain translates directly into a better quality of life during recovery.
Potentially lower use of opioid painkillers due to reduced postoperative pain.
Quicker return to normal activities with improved comfort during healing.
If you are facing anorectal surgery, this new research empowers you to have an informed discussion with your surgeon. You can ask:
Being an active participant in your surgical planning can help ensure you receive the most up-to-date and comfortable care available.
The randomized controlled trial comparing ChitoHem to electrocautery paints a promising picture for the future of anorectal and potentially other types of surgery. It demonstrates that modern medicine can move beyond merely being effective and towards being genuinely patient-centric.
The trade-off between the sheer speed of electrocautery and the markedly improved patient comfort offered by ChitoHem suggests a clear path forward. By adopting advanced hemostatic agents like ChitoHem, surgeons can now provide effective care that not only addresses the primary medical issue but also actively minimizes the burden of recovery. This research is a powerful reminder that sometimes, the gentlest cut is the most advanced one.