Prospective randomized clinical trial comparing two different circular staplers for mucosectomy in the treatment of hemorrhoids

Background: The main objections against circular stapled mucosectomy have been anal pain and rectal bleeding during the surgical procedure or in the immediate postoperative follow-up. To avoid these consequences, a new stapler (PPH33-03) has been developed. The aim of this trial was to compare the intraoperative and short-term postoperative morbidity of stapled mucosectomy with PPH33-01 versus PPH33-03 in the treatment of hemorrhoids. Methods: We conducted a prospective randomized clinical trial comparing hemorrhoidectomy with PPH33-01 (group 1, n = 30) versus PPH33-03 (group 2, n = 30) for grade III-IV symptomatic hemorrhoids. For the follow-up, the patients underwent examination and proctoscopy at 4 weeks, 3 months, and 6 months. We recorded anal pain (linear analog scale from 0 to 10), intraoperative hemorrhage, postoperative bleeding, and continence (Wexner Continence Grading Scale). Results: Demographic and clinical features showed no differences between the two groups. More patients required suture ligation to stop anastomotic bleeding at surgery when the PPH33-01 stapler was used (15 versus 4, P < 0.05). Rectal bleeding during the first postoperative 4 weeks was similar (P > 0.05). The postoperative pain scores during the first week were similar (P > 0.05). Patients with pain on defecation were fewer in the PPH-03 group (15 versus 2, P < 0.05). Six patients from group 1 and none from group 2 (P < 0.05) had granulomas along the line of staples at the sites of the reinforcing stitches; the granulomas were associated with postoperative anal discomfort and rectal bleeding. One patient in group 1 complained of persistent pain that resolved within 3 months. Of all the intraoperative or preoperative variables analyzed, only the presence of granuloma was associated with postoperative bleeding and anal discomfort. We have not found any recurrence or incontinence during the 6-month follow-up. Conclusions: Intraoperative bleeding along the stapled line and tenesmus or discomfort during defecation were less frequent after circular stapled mucosectomy with PPH33-03. Therefore, circular stapled mucosectomy with PPH33-03 decreases the risk of immediate complications and thus allows implantation with more safety as a day surgery procedure.