This is the first pilot study to compare the safety and effectiveness of disposable and reusable endoscope-guided retroflexed ERBL of internal hemorrhoids.
Endoscopic examination may stimulate the sympathetic nervous system, which leads to changes in blood pressure and heart rate 21,22. Cardiovascular events rarely happen but may be life threatening during colonoscopy, including cardiac arrhythmias (0.1%), bradycardia (0.8%), hypotension (1.2%) and death (0.007%-0.2%) 23–26. Heart rate fluctuation happened mainly during colonoscopy of the left side of bowel 26. Severe hemodynamic stress leads to myocardial ischemia, which may even be life-threatening 27. During ERBL, the shorter retroflex time and better flexibility of the endoscope can shorten the procedure and reduce the stimulation to patients. In this study, although the diastolic blood pressure fluctuations during the procedure were significantly vaster in the disposable endoscope group, they became stable after the procedure. Additionally, no patients developed life-threatening adverse events related to the endoscopic operation. Thus, this study proves a satisfactory safety of disposable endoscope.
Compared with reusable endoscopes, the overall performance of disposable endoscopes is satisfactory. Although the grades of image clarity and endoscopic flexibility were slightly lower for the disposable than reusable endoscopes (manifesting as a higher rate of grade B in the disposable endoscope group), all patients in both groups successfully underwent ERBL. Because ligating the hemorrhoids above the dentate line can reduce postoperative pain 28, correctly identifying the anorectal and dentate lines in the retroflexed position is crucial for endoscopists to confirm the location of ligation 14,29,30. Disposable endoscopes have two light-emitting diodes, a 110° view angle, and a 180° upward-bending angle that facilitate recognition of the structure and reaching of the operation site. However, the image brightness, sharpness, and contrast and the curvature of the disposable endoscope may require improvement to meet the needs of more accurate diagnosis and complex operations.
In this study, we found that the “cured” and “effective” rates on POD 30 were comparable between the two groups, indicating that disposable endoscopes have satisfactory operational stability and can be a promising option for retroflexed ERBL. The incidence of complications was also similar between the two groups. Common complications related to ERBL include bleeding (1.7%-15.4%) 13,31−33, pain (12.3%-50%) 32,34,35, and urinary retention (0.58%-7.7%) 13,33,36. Bleeding mostly occurs 7 to 10 days after ERBL because of the sloughing of the elastic ligating bands 36,37. During ERBL, matching between the endoscope and ligating device can guarantee complete suction of the hemorrhoids into the ligating device; this can prevent early slippage of the elastic bands, thus reducing the incidence of postoperative bleeding. For disposable endoscopes, the 10.8-mm outer diameter insertion tube and 3.00-mm diameter instrument channel can fit with multiple band ligation devices, thus avoiding in-procedure equipment failure and reducing the incidence of postoperative complications. Pain, sometimes associated to urinary retention 35, can be prevented by avoiding the dentate line when ligating as mentioned above 38. Only one patient in the disposable endoscope group developed urinary retention and ultrasound examination proved the diagnosis, but his postoperative VAS was 1 point. His history of prostatic hyperplasia and postoperative anal edema could explain his urinary retention, and his symptoms were relieved soon after perineum hot packing.
Disposable endoscopes have a wide range of clinical applications. First, they can be used directly after they are removed from the packaging and discarded following the medical waste management principles after use 39. This is suitable in some circumstances, such as in areas with a high rate of COVID-19 or in patients with multi-drug resistance. Second, they are convenient to carry and use in some specific situations, such as bedside endoscopy in the emergency setting and some complex endoscopic operations (such as endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy) 40,41.
Preventing cross contamination is the original intention of disposable endoscope. Although the risk of cross infection in the digestive tract is low, the awareness of eliminating the risk of cross infection will become increasingly important due to human progress and the increasing demand for medical capacity. And single-use is undoubtedly the most direct solution. Disposable endoscope is current, combined with the ability of industrial products, avoid crossing infection of the optimal solution. In addition, the total maintenance cost of reusable endoscope was 214.74RMB/case, including the cost of endoscopic sterilization 183.15 RMB, the cost of endoscopic repair 25.30 RMB, and the cost of endoscopic storage 6.29 RMB, when the maintenance cost of disposable endoscope can be totally saved. We are looking forward to the future will have more disposable endoscope studies and more products to solve the concerns of the contemporary to infection and cross pollution.