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

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.

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).

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.

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.