Endoscopic polidocanol foam sclerobanding for the treatment of grade II-III internal hemorrhoids: A prospective, multi-center, randomized study

World J Gastroenterol. 2024 Jul 21;30(27):3326-3335. doi: 10.3748/wjg.v30.i27.3326.

Abstract

Background: Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain.

Aim: To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL.

Methods: This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range.

Results: One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): -1.301 to -0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001].

Conclusion: Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.

Keywords: Endoscopic therapy; Internal hemorrhoids; Polidocanol foam; Rubber band ligation; Sclerobanding; Sclerotherapy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Female
  • Hemorrhoids* / diagnosis
  • Hemorrhoids* / surgery
  • Hemorrhoids* / therapy
  • Humans
  • Ligation / methods
  • Male
  • Middle Aged
  • Pain Measurement
  • Pain, Postoperative / diagnosis
  • Pain, Postoperative / etiology
  • Patient Satisfaction
  • Polidocanol* / administration & dosage
  • Polidocanol* / therapeutic use
  • Polyethylene Glycols / administration & dosage
  • Polyethylene Glycols / therapeutic use
  • Prospective Studies
  • Recurrence*
  • Sclerosing Solutions* / administration & dosage
  • Sclerotherapy* / methods
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Polidocanol
  • Sclerosing Solutions
  • Polyethylene Glycols