Effect of Abdominal Ice Pack After vNOTES Hysterectomy

Overview

This randomized, controlled, open-label, parallel-group clinical trial is designed to investigate the efficacy of abdominal ice pack application as an adjunct to standard pain management following vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) hysterectomy. Participants will be randomized in a 1:1 ratio into either the intervention group (ice pack application) or the control group (standard care). Patients in the control group will receive postoperative care adhering strictly to the standard ERAS (Enhanced Recovery After Surgery) protocol. The intervention group will receive abdominal ice pack applications using ice cubes enclosed in a 30x40 cm zipped bag inside a pillowcase, positioned directly on the abdomen from the symphysis pubis to the umbilicus and spanning the distance between both anterior superior iliac spines. Based on the patient's body mass, one or two ice packs will be applied for 20 minutes every two hours during the first 24 hours postoperatively. Physiologically, ice application slows down the metabolic rate of the contact tissue, thereby reducing free radical formation, promoting local vasoconstriction to minimize inflammation and edema, and inhibiting conduction in sensory nerve fibers. The primary hypothesis of this study is that patients receiving ice pack therapy will experience lower postoperative pain scores and decreased analgesic consumption compared to those receiving standard care alone. Ultimately, this trial aims to establish high-level clinical evidence regarding the effects of abdominal ice application on postoperative pain, bowel motility, and overall patient comfort, utilizing standardized questionnaires to assess pain levels and quality of life indices

Patient Selection and HomogeneityThis study will be conducted at Muğla Sıtkı Koçman University Training and Research Hospital, Department of Obstetrics and Gynecology, Infertility and Gynecology Outpatient Clinic. A total of 122 patients aged 48-70 years scheduled for vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) hysterectomy due to benign indications (such as uterine fibroids, abnormal uterine bleeding, or premalignant/malignant lesions) will be enrolled. To maintain sample homogeneity, psychological baseline levels will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which features 14 items scored on a 4-point Likert scale (0-3). Only patients with a HADS anxiety subscale score of $\\le$ 7 (asymptomatic/unlikely) will be included. Patients presenting with chronic pelvic pain, a history of opioid usage, endometriosis, or an anticipated requirement for extraordinary postoperative analgesia will be excluded.Preoperative Preparation and Baseline AssessmentsAll patients will receive preoperative preparation adhering to institutional Enhanced Recovery After Surgery (ERAS) protocols. Baseline routine laboratory tests, including complete blood count and biochemical profiles (hemoglobin, hematocrit, platelet count, white blood cell count, urea, creatinine, AST, ALT, CRP, sodium, potassium, and albumin), will be documented without ordering additional non-routine trials. Baseline demographic and clinical characteristics (age, body mass index, parity, history of previous operations, and surgical indications) will be recorded. No mechanical bowel preparation will be carried out preoperatively. Low-molecular-weight heparin will be administered as part of the routine thromboembolism prophylaxis.Standard Surgical Intervention and vNOTES TechniqueAll participants will undergo a standard vNOTES hysterectomy under standardized general anesthesia and endotracheal intubation. An orogastric tube will be placed for gastric decompression. A Foley catheter will be inserted preoperatively and removed at the 8th postoperative hour. Patients will be set in the dorsal lithotomy position with careful positioning to prevent hyperflexion and excessive external rotation of the hips, avoiding femoral and sciatic nerve injury.Following a standard surgical site preparation of the lower abdomen, upper thighs, and vagina, a weighted speculum will be placed into the posterior vagina to visualize the cervix, which will be held by two tenaculums (anterior and posterior). A circular incision will be performed around the cervicovaginal junction using electrocautery. The bladder will be mobilized anteriorly to enter the anterior colpotomy plane. Similarly, a posterior colpotomy will be completed by dissecting down to the insertion of the uterosacral ligaments. The anterior and posterior peritoneum will be entered and tagged with suture markers. A vNOTES advanced access platform will then be deployed vaginally, followed by carbon dioxide insufflation to create a pneumoperitoneum. Advanced bipolar electrocoagulation (LigaSure®, Covidien Company, MA, USA) will be utilized for tissue dissection and hemostasis. The vaginal cuff will be closed with a continuous polyglycolic acid (PGA) suture utilizing the Z-suture technique. Patients will be transferred to the ward after full recovery from anesthesia.Randomization and Study ArmsPatients will be sequentially enrolled and randomized in a 1:1 ratio into either the Intervention (Abdominal Ice Pack) Group or the Control (Standard Care) Group. Randomization will be executed once the patient achieves clinical stability postoperatively using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) based on a computer-generated variable block randomization sequence.Control Group: Patients will receive standard postoperative care according to the ERAS protocol without any ice application.Intervention Group: In addition to the standard ERAS protocol, patients will receive abdominal ice therapy. Ice cubes sealed in a 30x40 cm zipped bag inside a pillowcase will be applied directly onto the lower abdomen-extending from the symphysis pubis to the umbilicus and bridging the distance between both anterior superior iliac spines. Based on the patient's body mass index, 1 or 2 ice packs will be deployed for 20 minutes every 2 hours during the first 24 hours postoperatively.Both groups will share a identical rescue analgesic protocol.Postoperative Follow-up and Outcome MeasurementsPostoperative pain levels will be dynamically tracked at the 2nd, 6th, 12th, and 24th hours, as well as at the 2nd and 6th postoperative weeks, utilizing the Visual Analog Scale (VAS) (a 100 mm line ranging from 'no pain' to 'unbearable pain'). For objective reinforcement, the Face Pain Index (0-10 score) will be recorded by blinded medical staff at the 2nd, 6th, 12th, and 24th hours. If a patient's VAS score reaches $\\ge$ 4, rescue diclofenac will be given; if the VAS score is $\\ge$ 6, intravenous tramadol will be administered. Every analgesic intervention, dose, and administration timestamp will be diligently logged into individual Case Report Forms (CRFs).Bowel motility will be monitored daily until hospital discharge utilizing the I-FEED scoring system, tracking oral intake, nausea, vomiting, physical examination findings, and the overall duration of symptoms. Patients and family members will be instructed to notify the research assistant immediately upon the first passage of flatus or stool. Additionally, the Quality of Recovery-15 (QoR-15) questionnaire, assessing pain, physical comfort, independence, psychological support, and emotional state across 15 questions (total score 0-150), will be completed by all patients prior to hospital discharge. All study metrics, documentation errors, or dropouts will be handled using indelible ink on printed CRFs and secured in protected archives for statistical analysis.