Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial

Abstract

Background: Long-term outcomes and efficacy of partial stapled hemorrhoidopexy are not known.

Objective: The purpose of this study was to compare the long-term clinical efficacy and safety of partial stapled hemorrhoidopexy with circumferential stapled hemorrhoidopexy.

Design: This was a parallel group, randomized, noninferiority clinical trial.

Settings: The study was conducted at a single academic center.

Patients: Patients with grade III/IV hemorrhoids between August 2011 and November 2013 were included.

Interventions: Three hundred patients were randomly assigned to undergo either partial stapled hemorrhoidopexy (group 1, n = 150) or circumferential stapled hemorrhoidopexy (group 2, n = 150).

Main outcome measures: The primary outcome was the rate of recurrent prolapse at a median follow-up period of 5 years with a predefined noninferiority margin of 3.75%. Secondary outcomes included incidence and severity of postoperative pain, fecal urgency, anal continence, and the frequency of specific complications, including anorectal stenosis and rectovaginal fistula.

Results: The visual analog scores in group 1 were less than those in group 2 (p < 0.001). Fewer patients in group 1 experienced postoperative urgency compared with those in group 2 (p = 0.001). Anal continence significantly worsened after both procedures, but the difference between preoperative and postoperative continence scores was higher for group 2 than for group 1. Postoperative rectal stenosis did not develop in patients in group 1, although it occurred in 8 patients (5%) in group 2 (p = 0.004). The 5-year cumulative recurrence rate between group 1 (9% (95% CI, 4%-13%)) and group 2 (12% (95% CI, 7%-17%)) did not differ significantly (p = 0.137), and the difference was within the noninferiority margin (absolute difference, -3.33% (95% CI, -10.00% to 3.55%)).

Limitations: The study was limited because it was a single-center trial.

Conclusions: Partial stapled hemorrhoidopexy is noninferior to circumferential stapled hemorrhoidopexy for patients with grade III to IV hemorrhoids at a median follow-up period of 5 years. However, partial stapled hemorrhoidopexy was associated with reduced postoperative pain and urgency, better postoperative anal continence, and minimal risk of rectal stenosis. See Video Abstract at http://links.lww.com/DCR/A790.Trial registration (chictr.org) identifier is chiCTR-trc-11001506.

FIGURE 1.

Participant enrollment and follow-up (CONSORT flow diagram). PSH = partial stapled hemorrhoidopexy; CSH = circumferential stapled hemorrhoidopexy.

FIGURE 2.

Model-based visual analog scale (VAS) scores by treatment groups and time on study with error bars indicate 2-sided 95% CIs. PSH = partial stapled hemorrhoidopexy; CSH = circumferential stapled hemorrhoidopexy.

FIGURE 3.

Model-based percentages for postoperative fecal urgency by treatment groups and time on study. PSH = partial stapled hemorrhoidopexy; CSH = circumferential stapled hemorrhoidopexy.

FIGURE 4.

Model-based Jorge-Wexner incontinence scores by treatment groups and time on study with error bars indicate 2-sided 95% CIs. PSH = partial stapled hemorrhoidopexy; CSH = circumferential stapled hemorrhoidopexy.

FIGURE 5.

Cumulative recurrent rate stratified by (A) treatment group, (B) grade, (C) treatment group and grade, and (D) age. PSH = partial stapled hemorrhoidopexy; CSH = circumferential stapled hemorrhoidopexy.

FIGURE 6.

The 5-year cumulative recurrence rate difference and the noninferiority margin.