Albumin-glutaraldehyde bioadhesive ("Bioglue") for prevention of postoperative complications after stapled hemorrhoidopexy: A randomized controlled trial.
BACKGROUND
Hemorrhoidopexy using the circumferential stapler is an established method for surgical treatment of patients with prolapsing hemorrhoids. Despite its advantages, complications such as anal canal stenosis, hemorrhage and anastomosis leak with eventual intrapelvic sepsis can cause serious postoperative problems. The aim of this study was to evaluate the utility of a surgical adhesive, the biological albumin-glutaraldehyde glue "Bioglue", in reduction of these postoperative complications.


METHODS
Between January 2002 and November 2004, 200 patients undergoing stapled hemorrhoidopexy were enrolled in a prospective, randomized clinical trial. One hundred patients were randomly assigned to the control group; the study group consisted of 100 patients who received Bioglue in the mucosa anastomosis area. All patients received standardized postoperative analgesic, laxative and antibiotic treatment. We then evaluated the two groups for postoperative complications (after surgery and 6 months postoperatively).


RESULTS
From the control group (no Bioglue application), two patients presented with anal stenosis, two with hemorrhage, three had anastomosis leak and one had thrombosis, whereas none of the patients from the Bioglue group had any of these complications. Both groups had patients with severe postoperative pain (3 each) and fecal incontinence (1 patient each). The overall difference in the number of complications in the two groups was statistically significant (p < 0.05).


CONCLUSIONS
In this first study using Bioglue in patients undergoing circumferential stapled hemorrhoidopexy we have shown that application of the glue is effective in reducing postoperative complications.
Anghelacopoulos
Sotirios E
SE
2nd Surgical Department, Theageneion Hospital, Thessaloniki, Greece.
Tagarakis
Georgios I
GI
Pilpilidis
Ioannis
I
Kartsounis
Christos
C
Chryssafis
Georgios
G
D016009:Chi-Square Distribution; D005242:Fecal Incontinence / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006484:Hemorrhoids / Q000601:surgery*; D006801:Humans; D007413:Intestinal Mucosa / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000517:prevention & control; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011506:Proteins; D013528:Surgical Staplers; D013997:Time Factors; D014014:Tissue Adhesives
C472676:Bio-glue; D011506:Proteins; D014014:Tissue Adhesives