ENSEAL® Hemorrhoidectomy, a Novel Technique, Versus Conventional Open Method for the Management of Grade III and IV Hemorrhoids.

Background Surgical removal of hemorrhoids is the gold-standard treatment for symptomatic grade III and IV hemorrhoid disease. There are numerous ways the hemorrhoidectomy surgical procedure is done but the most effective and least painful way is still to be elucidated. Objective To compare the outcomes of ENSEAL® (Ethicon, Inc., Raritan, USA) versus gold standard Milligan-Morgan hemorrhoidectomy in patients presenting with grade-III and IV hemorrhoids Materials and methods After ethical approval, the Randomized Controlled Trial was conducted at the Department of Surgery, Unit III, Lahore General Hospital, Lahore, Pakistan, between January 2020 and January 2022. In this study, 140 patients who met the inclusion criteria were recruited after informed consent. Patients were split randomly into two equal groups using a lottery technique. In group A, hemorrhoidectomy was carried out with ENSEAL®, whereas in group B, open hemorrhoidectomy was performed by the Milligan-Morgan method. the surgery duration and blood loss were noted. After the operation, patients were transferred to and discharged from the post-anesthesia recovery room. Patients were further followed up for pain scores after 24 hours. Data was analyzed by using Statistical Package for Social Sciences (SPSS) v25 (IBM Corp., Armonk, USA). Data was categorized for age, gender, body mass index (BMI), degree of hemorrhoids, and duration of hemorrhoids. A p-value <0.05 was considered significant. Results 140 patients were included in this study. Group A patients underwent ENSEAL® hemorrhoidectomy, and group B was formed from those who underwent the Milligan-Morgan procedure. In group A, there were 41 (58.5%) males and 29 (41.4%) females, while in group B, there were 43 (61.4%) males and 27 (38.5%) females. The mean age of group A patients was 49.97 ± 7.36 years and 43.2 ± 8.01 years in group B. In group A, the mean operative time was 20.87 ± 3.05 min, while 27.10 ± 3.42 min in group B, which is statistically significant with a p-value of <0.001. In group A, mean blood loss was 9.79 ± 2.87 ml, while 13.36 ± 3.73 ml in group B, which is statistically significant with a p-value of <0.001. In group A, the mean pain score was 2.7 ± 1.08, while 3.34 ± 1.16 in group B, which is statistically significant with a p-value of <0.001. Conclusion When considering the length of the procedure and blood loss, ENSEAL® hemorrhoidectomy has been determined to be an effective treatment that the patients tolerated well. Therefore, ENSEAL® hemorrhoidectomy can be a safe and efficient alternative to conventional treatment for hemorrhoids that are causing symptoms.