The SCI-Pex study on PexyEazy: a novel instrument and technique for haemorrhoid mucopexy

Abstract Introduction PexyEazy is a new device for surgical treatment of grade II-III haemorrhoids. The device enables semi-automated mucopexy in awake or sedated patients. The SCI-Pex study is a descriptive multicentre study aiming to evaluate the safety and feasibility of the PexyEazy-procedure in a clinical setting. This interim analysis reports short-term outcomes. Method The PexyEazy device is a proctoscope that semi-automatically places sutures above the internal haemorrhoids. When suction is applied, the mucosa folds, allowing needles to be pushed through the mucosa, connecting to sutures stored at the tip of the device, and thereafter retracted and tied, resulting in a mucopexy. The procedures were performed under general anaesthesia, sedation or awake. Clinical outcomes and postoperative data were collected via questionnaires by both patients and surgeons. Result 21 patients (11 Female, 10 Male) were treated in three centres by six surgeons and followed up after one week. Five patients had grade II and 15 grade III haemorrhoids. Mean procedure time was 28 minutes (range 16-43 min). Ten patients had general anaesthesia, eight sedation and three were awake. No serious adverse events occurred. Two patients had minor bleedings (Clavien-Dindo grade 1). One procedure was aborted due to device malfunction. No excessive peri- or postoperative pain were reported. Discussion The PexyEazy procedure appears to be safe for the treatment of grade II-III haemorrhoids in awake or sedated patients. No serious complications or excessive pain were reported. Further studies are required to evaluate the efficacy of the procedure and to compare outcomes with established procedures.