High-Volume Transanal Surgery with CPH34 HV for the Treatment of III-IV Degree Haemorrhoids: Final Short-Term Results of an Italian Multicenter Clinical Study

The clinical chart of 621 patients with III-IV haemorrhoids undergoing Stapled Hemorrhoidopexy (SH) with CPH34 HV in 2012-2014 was consecutively reviewed to assess its safety and efficacy after at least 12 months of follow-up. Mean volume of prolapsectomy was significantly higher (13.0 mL; SD, 1.4) in larger prolapse (9.3 mL; SD, 1.2) (p < 0.001). Residual or recurrent haemorrhoids occurred in 11 of 621 patients (1.8%) and in 12 of 581 patients (1.9%), respectively. Relapse was correlated with higher preoperative Constipation Scoring System (CSS) (p = 0.000), Pescatori's degree (p = 0.000), Goligher's grade (p = 0.003), prolapse exceeding half of the length of the Circular Anal Dilator (CAD) (p = 0.000), and higher volume of prolapsectomy (p = 0.000). At regression analysis, only the preoperative CSS, Pescatori's degree, Goligher's grade, and volume of resection were significantly predictive of relapse. A high level of satisfaction (VAS = 8.6; SD, 1.0) coupled with a reduction of 12-month CSS (Δ preoperative CSS/12 mo CSS = 3.4, SD, 2.0; p < 0.001) was observed. The wider prolapsectomy achievable with CPH34 HV determined an overall 3.7% relapse rate in patients with high prevalence of large internal rectal prolapse, coupled with high satisfaction index, significant reduction of CSS, and very low complication rates

Residual Prolapse in Patients with III-IV Degree Haemorrhoids Undergoing Stapled Haemorrhoidopexy with CPH34 HV. Results of an Italian Multicentric Clinical Study

Patientswith haemorrhoids and large internal rectal prolapse are at high risk of relapse after stapled haemorrhoidopexy (SH) due to the limited prolapse resection achievable with currently available staplers. Stapled transanal rectal resection (STARR) was tested to overcome such technological limitations, although it requires a double rectal resection. A novel stapler device, CPH34 HV, with a high volume stapler casing, was tested in a multicenter clinical study in order to assess its safety and efficacy in this clinical setting. Patients and Methods. The clinical chart of 430 patients (209 males and 221 females; mean age of 51 years; SD, 13.4 years) with third- to fourth-degree haemorrhoids undergoing SH in 2012-2013 was consecutively reviewed. Patients with symptoms of obstructed defecation syndrome (ODS), second-degree rectocele (2–4 cm), and a Wexner’s constipation score over 15 were excluded. Follow-up was scheduled at six and 12 months after the operation. Results. Three hundred forty-one patients (79.3%) had an internal rectal prolapse exceeding more than half of CAD. One technical failure of the device was reported (0.2%) without any untoward effect as for the operation; 1.3 stitch/patient (SD, 1.7) was required to achieve complete haemostasis of the suture line. The mean in-hospital stay was 1.6 days (SD, 1; range, 1–4). The mean volume of the doughnuts was significantly higher (13.8 mL; SD, 1.5) in patients with a large rectal prolapse than with smaller one (8.9 mL; SD, 0.7) (-value < 0.05). Residual and recurrent haemorrhoids occurred in eight out of 430 patients (1.8%) and in five out of 254 patients (1.9%), respectively, withmost of them having originally a large rectal prolapse. A high index of patient satisfaction (visual analogue scale = 8.9; SD, 0.9) coupled with a persistent reduction of constipation scores (CSS = 5.0, SD, 2.2) was observed. Conclusions.The wider prolapse resection well correlated with a clear-cut reduction of haemorrhoidal relapse, a high index of patient satisfaction, and clinically-relevant reduction of constipations scores coupled with satisfactory haemostatic properties of CPH34 HV