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

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.