Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial.

AIM: In patients with fistulizing perianal Crohn's disease (CD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained fistulizing perianal CD treated with adalimumab. METHODS: This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The primary end-point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities. RESULTS: Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (P = 0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (P = 0.426), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group (P = 1.000). CONCLUSIONS: Seton removal alone seems to be no more effective than a secondary surgical step (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.

Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.

OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.

[Hemorrhoidal surgery: new trends for day-case surgery]. / Chirurgie hémorroïdaire : évolution vers une prise en charge en ambulatoire.

Despite recommendations and encouragements, day-case hemorrhoidal surgery is incompletely developed. The incidence of postoperative pain, urinary retention and the risk of bleeding vary according to the surgical procedure but they are considered as the main impediments to ambulatory management. Consequently, besides the use of good clinical practice concerning ambulatory surgery, hemorrhoidal surgery requires an effective control of postoperative pain based on the use of pudendal block, an adaptation of the anesthetic technique and a careful postoperative follow-up.

Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery.

PURPOSE: This study was conducted to assess the efficacy of infiltration with a new local anesthetic (ropivacaine) to control pain after hemorrhoidal surgery. METHODS: Thirty-four patients who underwent hemorrhoidectomy were included in a double-blind, randomized study to assess the analgesic effect of a perianal infiltration with 40 ml of 0.75 percent ropivacaine compared with isotonic saline infiltration. Postoperatively, pain was assessed on a visual analog scale, and intravenous morphine consumption was measured with patient-controlled administration. RESULTS: In the ropivacaine group, patients had lower visual analog scale scores at 1, 3, and 6 hours after infiltration and required fewer cumulative doses of morphine (patient-controlled administration) at 3, 6, and 12 hours. Side effects were comparable in the two groups. CONCLUSION: Local infiltration with ropivacaine improves pain control and patient comfort in the immediate postoperative course of hemorrhoidal surgery.