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
Who can participate
Age range
48 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled to undergo elective vaginal natural orifice transluminal endoscopic surgery hysterectomy.
* Patients with benign gynecological indications including uterine leiomyoma, adenomyosis, or abnormal uterine bleeding.
* Patients with premalignant gynecological indications including atypical endometrial hyperplasia or cervical intraepithelial neoplasia.
* Patients managed strictly under the standardized institutional Enhanced Recovery After Surgery protocol.
* Patients with an American Society of Anesthesiologists physical status classification of I or II.
* Patients who demonstrate adequate cognitive capacity to understand and utilize the Visual Analog Scale and Face Pain Index.
* Patients who voluntarily provide signed written informed consent prior to participating in the clinical study.
Exclusion Criteria:
* Patients with a documented history of chronic pelvic pain or systemic chronic pain syndromes.
* Patients with known hypersensitivity, allergy, cold urticaria, or intolerance to local cryotherapy or cold applications.
* Patients with a history of prior major open abdominal surgery
* Active pregnancy, suspected pregnancy, or current lactation status at the time of enrollment.
* Patients with severe systemic diseases including uncontrolled diabetes mellitus, severe hepatic impairment, or end-stage renal disease.
* Coagulation disorders, active bleeding diathesis, or patients on mandatory continuous anticoagulant therapy.
* Diagnosed psychiatric…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Scores
Timeframe: Postoperative 2nd, 6th, 12th, and 24th hours, and postoperative 2nd and 6th weeks.