Less-Invasive Stapling Procedure May Decrease Hemorrhoid Pain

October 20, 2005

Oct. 20, 2005 (San Francisco) — Stapled hemorrhoidopexy results in significantly less pain and similar clinical outcomes as standard hemorrhoidectomy, according to 14-month follow-up data from a prospective randomized trial.

"We see significant and consistent advantages in terms of pain control and the number of patients taking analgesics [with the less invasive procedure]," said Anthony J. Senagore, MD, FACS, professor and chairman of the Department of Surgery at the Medical University of Ohio in Toledo, during his presentation here at the American College of Surgeons annual meeting.

A total of 240 patients were enrolled in the study; 122 were randomized to receive a standard Ferguson hemorrhoidectomy and 118 to the stapled hemorrhoidopexy group. Of those, 99 patients (81%) and 103 patients (87%), respectively, completed the assigned procedure according to protocol. In the stapling hemorrhoidopexy surgery, called the Procedure for Prolapse and Hemorrhoids (PPH; Ethicon Endo-Surgery, Inc.), the surgeon lifts the sagging or prolapsed mucosa in the anal canal and uses a circular stapler to relocate the tissue above the dentate line. Blood flow is reduced to the tissue after the procedure, causing the hemorrhoids to shrink.

The acute results from the study, which have been reported previously, show that there is no significant difference in the number of patients who were treated on an outpatient basis between the two groups, with 88% in the Ferguson hemorrhoidectomy group completing therapy in an outpatient setting compared with 87% in the stapling hemorrhoidopexy group.

Nor was there a difference in the time to first bowel movement, with a median of two days in the Ferguson group compared with one day in the stapling group ( P = .052, as measured in 64 and 67 patients, respectively). There was, however, significantly more pain reported in the Ferguson group, with a mean pain score of 6.6 vs 4.8 in the stapling group ( P = .002; n = 66 and 68, respectively).

The difference in pain rating continued to be significantly different between the two groups from day one ( P = .002) to day 14 after surgery ( P = .011). The most severe pain rated decreased over that time period for both groups.

"At about a week [after surgery], almost all of the pain they had experienced due to their hemorrhoids had resolved," said Dr. Senagore, referring to those patients treated with the hemorrhoidopexy surgery. "Even at two weeks the Ferguson group had not really caught up to that and were still recovering from their surgery."

However, at one year follow-up there was no difference between the two groups in terms of control of index symptoms. "At one year there was almost complete resolution of symptoms in both groups," said Dr. Senagore.

In terms of adverse events after surgery, most complications were similar, although the number of individuals with wound infections was higher in the Ferguson group compared with the stapling group (16 [13%] vs 7 [6%]).

"This is a very important study," said Bruce Wolff, MD, professor of surgery, Mayo Clinic College of Medicine in Rochester, Minnesota, speaking as a formal discussant for the paper. "The results are similar to European trials, where the use of stapling procedures to control hemorrhoids has longer tradition. However, an important question is whether one-year is really long-term follow-up, as other studies have shown a higher rate of complications [with this procedure] at 16 months."

The current study was funded by an unrestricted educational grant to the American Society of Colon and Rectal Surgeons from Ethicon Endo-Surgery, Inc., who make the device used in the new procedure. Dr. Senagore is on the advisory board of Ethicon Endo-Surgery, Inc.

ACS 91st Annual Clinical Congress: Papers Session I. Presented Oct. 18, 2005.

Reviewed by Gary D. Vogin, MD