Evaluating Deep Neuromuscular Blockade and Low-Residue Diet to Improve Surgical Conditions During Vaginal Natural Orifice Transluminal Endoscopic Surgery Hysterectomy

What this Trial Is About

Researchers are evaluating two measures to improve the surgical field during vaginal natural orifice transluminal endoscopic surgery vNOTES hysterectomy, a procedure performed entirely through the vagina without abdominal incisions. The study is a randomized trial using a 2x2 factorial design to test whether a preoperative low-residue diet for three days, deeper intra-operative muscle relaxation deep neuromuscular blockade, or their combination improve visualization by reducing bowel interference. This trial focuses on benign gynecological conditions such as uterine leiomyoma, abnormal bleeding, uterine prolapse, and adenomyosis. Participants are assigned equally to one of four groups no diet with standard relaxation, diet with standard relaxation, no diet with deep relaxation, or diet with deep relaxation the bundle. Deep neuromuscular blockade is maintained by continuous rocuronium infusion, while standard relaxation uses intermittent rocuronium boluses both groups receive reversal with sugammadex before extubation. The low-residue diet restricts fiber intake to less than 10 grams daily for three days before surgery, avoiding raw fruits, vegetables, legumes, nuts, and seeds but allowing refined grains and cooked foods. No mechanical bowel preparation is used in any group. During surgery, the surgical field is assessed objectively by lowering carbon dioxide insufflation pressure stepwise from 12 to 6 mmHg while blinded assessors score video clips for field adequacy. Researchers measure the lowest pressure at which the surgical field remains adequate as the primary outcome. Secondary measures include continuous field scores, need for additional instruments, postoperative nausea and vomiting, operative time, blood loss, and complications. Participants are monitored during surgery and up to 24 hours postoperatively, with full neuromuscular recovery confirmed before extubation.

Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy