A comparative study on efficacy and safety of modified partial stapled hemorrhoidopexy versus conventional hemorrhoidectomy: a prospective randomized controlled trial

Abstract

Purpose: The long-term outcomes and efficacy of partial stapled hemorrhoidopexy (PSH) compared with those of conventional hemorrhoidectomy (CH) are not fully understood. This study aimed to introduce a modified PSH (mPSH) and compare its clinical efficacy and safety with those of CH.

Methods: A prospective randomized controlled trial was conducted. This study was performed at a single hospital and involved 6 colorectal surgeons. In total, 110 patients were enrolled between July 2019 and September 2020. Patients were randomly assigned to undergo either mPSH group (n=55) or CH group (n=55). The primary outcome was to compare postoperative average pain and postoperative peak pain using visual analog scale score between the 2 groups.

Results: The required duration of analgesia was shorter in the mPSH group than in the CH group, although the difference was not statistically significant (P=0.096). However, the laxative requirement duration (P<0.010), return to work (P<0.010), satisfaction score (P<0.010), and Vaizey score (P=0.014) were significantly better in the mPSH group. The average and peak postoperative pain scores were significantly lower in the mPSH group during the 15 days after surgery (P<0.001). The overall complication rate in both groups was 9.1%, with no significant difference between the groups (P=0.867).

Conclusion: The mPSH group demonstrated better improvement in symptoms, lower pain scores, and greater patient early satisfaction after surgery than the CH group. Therefore, this surgical technique appears to be a safe and effective alternative for CH.

Keywords: Hemorrhoids; Partial stapled hemorrhoidopexy; Prospective randomized controlled trial; Quality of life.

Fig. 1.

Study flowchart. NSAID, nonsteroidal anti-inflammatory; mPSH, modified partial stapled hemorrhoidopexy; CH, conventional hemorrhoidectomy.

Fig. 2.

Preoperative and postoperative findings. (A) Preoperative image of prolapsed hemorrhoid. (B) A tri-window anoscope inserted, before a mixture of lidocaine and epinephrine is injected. (C) The inserted tri-window anoscope being injected. (D) A tri-window anoscope inserted, after injection. (E) After circular stapler firing status. (F) Suture ligation on 6 excised mucosal end to prevent postoperative bleeding. (G) Postoperative image of complete reduction of the prolapse by modified partial stapled hemorrhoidopexy method.

Fig. 3.

Postoperative pain scores measured by visual analog scale (VAS) were compared between the conventional hemorrhoidectomy (CH) group and the modified partial stapled hemorrhoidopexy (mPSH) group using the generalized estimating equation method. (A) The postoperative average pain VAS score in the mPSH group was significantly lower than the CH group (P<0.001). (B) The postoperative peak pain VAS score in the mPSH group was significantly lower than the CH group (P<0.001).