PURPOSE
There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States.
METHODS
Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery.
RESULTS
A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery.
CONCLUSIONS
These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.
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REFERENCES
Longo A. Treatment of hemorrhoidal disease by reduction of mucosa and hemorrhoidal prolapse with a circular suturing device: a new procedure. In: Proceedings of the 6th World Congress of Endoscopic Surgery, Rome, Italy, June 3–6, 1998.
MA Singer JR Cintron JW Fleshman et al. (2002) ArticleTitleEarly experience with stapled hemorrhoidectomy in the United States Dis Colon Rectum 45 260–7 Occurrence Handle10.1007/s10350-004-6183-3
SR Brown K Ballan E Ho YH Ho Fams F Seow-Choen (2001) ArticleTitleStapled mucosectomy for acute thrombosed circumferentially prolapsed piles: a prospective randomized comparison with conventional haemorrhoidectomy Colorectal Dis 3 175–8 Occurrence Handle10.1046/j.1463-1318.2001.00224.x Occurrence Handle1:STN:280:DC%2BD3s3msFShsw%3D%3D Occurrence Handle12790985
MJ Cheetham CR Cohen MA Kamm RK Phillips (2003) ArticleTitleA randomized, controlled trial of diathermy hemorrhoidectomy vs. stapled hemorrhoidectomy in an intended day-care setting with longer-term follow-up Dis Colon Rectum 46 491–7 Occurrence Handle10.1007/s10350-004-6588-z Occurrence Handle1:STN:280:DC%2BD3s7msVeisg%3D%3D Occurrence Handle12682543
JM Correa-Rovelo O Tellez L Obregon A Miranda-Gomez S Moran (2002) ArticleTitleStapled rectal mucosectomy vs. closed hemorrhoidectomy: a randomized, clinical trial Dis Colon Rectum 45 1367–75 Occurrence Handle12394436
E Ganio DF Altomare F Gabrielli G Milito S Canuti (2001) ArticleTitleProspective randomized multicentre trial comparing stapled with open haemorrhoidectomy Br J Surg 88 669–74 Occurrence Handle10.1046/j.0007-1323.2001.01772.x Occurrence Handle1:STN:280:DC%2BD3M3mslentw%3D%3D Occurrence Handle11350437
FH Hetzer N Demartines AE Handschin PA Clavien (2002) ArticleTitleStapled vs. excision hemorrhoidectomy: long-term results of a prospective randomized trial Arch Surg 137 33–340
Y-H Ho W-K Cheong C Tsang J Ho C-L Tang F Seow-Choen (2000) ArticleTitleStapled hemorrhoidectomy – cost and effectiveness: randomized, controlled trial including incontinence scoring, anorectal monometry, and endoanal ultrasound assessments at up to three months Dis Colon Rectum 43 1666–75 Occurrence Handle1:STN:280:DC%2BD3M%2FpvFGrtQ%3D%3D Occurrence Handle11156449
YH Ho C Tsang CL Tang D Nyam KW Eu F Seow-Choen (2000) ArticleTitleAnal sphinicter injuries from stapling instruments introduced transanally: randomized, controlled study with endoanal ultrasound and anorectal manometry Dis Colon Rectum 43 169–73 Occurrence Handle1:STN:280:DC%2BD3c7lvF2lsA%3D%3D Occurrence Handle10696889
M Kairaluoma K Nuorva I Kellokumpu (2003) ArticleTitleDay-case stapled (circular) vs. diathermy hemorrhoidectomy: a randomized, controlled trial evaluating surgical and functional outcome Dis Colon Rectum 46 93–9 Occurrence Handle10.1007/s10350-004-6502-8 Occurrence Handle12544528
A Maw R Concepcion KW Eu F Seow-Choen SM Heah CL Tang AL Tan (2003) ArticleTitleProspective randomized study of bacteraemia in diathermy and stapled haemorrhoidectomy Br J Surg 90 222–6 Occurrence Handle10.1002/bjs.4057 Occurrence Handle1:STN:280:DC%2BD3s%2FksVymtQ%3D%3D Occurrence Handle12555300
BJ Mehigan JR Monson JE Hartley (2000) ArticleTitleStapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomized controlled trial Lancet 355 782–5 Occurrence Handle10.1016/S0140-6736(99)08362-2 Occurrence Handle1:STN:280:DC%2BD3c7nsFSruw%3D%3D Occurrence Handle10711925
H Ortiz J Marzo P Armendariz (2002) ArticleTitleRandomized clinical trial of stapled haemorrhoidopexy versus conventional diathermy haemorrhoidectomy Br J Surg 89 1376–81 Occurrence Handle10.1046/j.1365-2168.2002.02237.x Occurrence Handle1:STN:280:DC%2BD38njt1agtA%3D%3D Occurrence Handle12390376
D Palimento M Picchio U Attanasio A Lombardi C Bambini A Renda (2003) ArticleTitleStapled and open hemorrhoidectomy: randomized controlled trial of early results. World J Surg 27 203–7 Occurrence Handle12616437
T Pavlidis B Papaziogas A Souparis A Patsas I Koutelidakis T Papaziogas (2002) ArticleTitleModern stapled Longo procedure vs. conventional Milligan-Morgan hemorrhoidectomy: a randomized controlled trial Int J Colorectal Dis 17 50–3 Occurrence Handle10.1007/s003840100342 Occurrence Handle1:STN:280:DC%2BD383nslGlsQ%3D%3D Occurrence Handle12018455
BC Peng DG Jayne Y-H Ho (2003) ArticleTitleRandomized trial of rubber band liagiton vs. stapled hemorrhoidectomy for prolapsed piles Dis Colon Rectum 46 291–7 Occurrence Handle10.1007/s10350-004-6543-z Occurrence Handle12626901
M Roswell M Bello DM Hemingway (2001) ArticleTitleCircumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomized controlled trial Lancet 355 779–81 Occurrence Handle10.1016/S0140-6736(99)06122-X
R Shalaby A Desoky (2001) ArticleTitleRandomized clinical trial of stapled versus Milligan-Morgan haemorrhoidectomy Br J Surg 88 1049–53 Occurrence Handle10.1046/j.0007-1323.2001.01830.x Occurrence Handle1:STN:280:DC%2BD3MvktlWhsQ%3D%3D Occurrence Handle11488788
MS Wilson V Pope HE Doran SJ Fearn WA Brough (2002) ArticleTitleObjective comparison of stapled anopexy and open hemorrhoidectomy: a randomized, controlled trial Dis Colon Rectum 45 1437–44 Occurrence Handle1:STN:280:DC%2BD38nntFShuw%3D%3D Occurrence Handle12432288
TH Rockwood JM Church JW Fleshman et al. (2000) ArticleTitleFecal Incontincence Quality of Life Scale: Quality of Life Instrument for Patients with Fecal Incontinence Dis Colon Rectum 43 9–17 Occurrence Handle1:STN:280:DC%2BD3c3ntFahtw%3D%3D Occurrence Handle10813117
ML Corman (1998) Hemorrhoids ML Corman (Eds) Colon and rectal surgery EditionNumber4th ed Lippincott-Raven Philadelphia 147–205
S Nivatvongs (1999) Hemorrhoids PH Gordon S Nivatvongs (Eds) Principles and practice of surgery for the colon, rectum, and anus EditionNumber2nd ed Quality Medical Publishing St. Louis 193–215
P Roos (2000) ArticleTitleHaemorrhoid surgery revised Lancet 355 768–9 Occurrence Handle10.1016/S0140-6736(00)00086-6 Occurrence Handle10711919
RG Molloy D Kingsmore (2000) ArticleTitleLife threatening pelvic sepsis after stapled hemorrhoidectomy Lancet 355 810 Occurrence Handle10.1016/S0140-6736(00)02208-X Occurrence Handle1:STN:280:DC%2BD3c7nsFSqug%3D%3D Occurrence Handle10711934
A Herold JJ Kirsch (2001) ArticleTitleComplications after circular stapled hemorrhoidectomy: results of an inquiry in Germany Coloproctology 23 8–16
V Ripetti M Caricato A Arullani (2002) ArticleTitleRectal perforation, retropneumoperitoneum, and pneumomediastinum after stapling procedure of prolapsed hemorrhoids: report of a case and subsequent considerations Dis Colon Rectum 45 268–70 Occurrence Handle10.1007/s10350-004-6159-3 Occurrence Handle11852343
MJ Cheetham NJ Mortensen PO Nystom MA Kamm RK Phillips (2000) ArticleTitlePersistent pain and faecal urgency after stapled haemorrhoidectomy Lancet 356 730–33 Occurrence Handle10.1016/S0140-6736(00)02632-5 Occurrence Handle1:STN:280:DC%2BD3M%2FjvVKquw%3D%3D Occurrence Handle11085693
ACKNOWLEDGMENT
The authors thank Dr. Ty McClure for his assistance with the statistical analysis.
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Supported by Ethicon Endo-Surgery, Cincinnati, Ohio.
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Senagore, A., Singer, M., Abcarian, H. et al. A Prospective, Randomized, Controlled Multicenter Trial Comparing Stapled Hemorrhoidopexy and Ferguson Hemorrhoidectomy: Perioperative and One-Year Results. Dis Colon Rectum 47, 1824–1836 (2004). https://doi.org/10.1007/s10350-004-0694-9
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DOI: https://doi.org/10.1007/s10350-004-0694-9