Effect of Abdominal Ice Pack After vNOTES Hysterectomy

NCT07626684 · tracked via the Priya Life Science Turkey tracker

Sponsor

Erzincan Military Hospital

Phase

Not applicable

Started

2026-10-01

Last updated

2026-06-04

Condition(s) studied

Hysterectomy, Benign Uterine DiseasesHysterectomy, VaginalvNOTESPostoperative Pain Following HysterectomyPatient Comfort and SafetyBowel FunctionsAnalgesic Consumption

Investigational drug(s) / intervention(s)

Abdominal Ice Pack + ERAS

Abdominal Ice Pack + ERAS: This physical intervention involves the local application of cryotherapy onto the abdominal wall following vNOTES hysterectomy. Ice cubes are enclosed inside a 30x40 cm zipped plastic bag and placed within a textile pillowcase to provide a safe barrier. The pack is applied directly to the lower abdomen, covering the area from the symphysis pubis to the umbilicus and horizontally between both anterior superior iliac spines. Based on the patient's body mass, 1 or 2 ice packs are deployed simultaneously. This protocol is performed for exactly 20 minutes every 2 hours during the first 24 hours postoperatively. This therapy is administered strictly as an adjunct to the standard institutional Enhanced Recovery After Surgery (ERAS) protocol.

Study summary

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

Eligibility

Sex

FEMALE

Min age

48 Years

Max age

70 Years

Healthy volunteers

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 disorders, severe depression, anxiety, or cognitive impairment preventing valid clinical outcome scoring. * Intraoperative conversion from vaginal natural orifice transluminal endoscopic surgery to conventional laparoscopy or open laparotomy. * Patients experiencing major intraoperative complications including severe vascular, bladder, bowel, or ureteral injury. * Patients requiring perioperative blood product transfusion due to significant estimated blood loss during surgery.

Primary outcome measure(s)

Postoperative Pain Scores — Postoperative 2nd, 6th, 12th, and 24th hours, and postoperative 2nd and 6th weeks.
ostoperative pain levels will be assessed using the Visual Analog Scale (VAS), which is a 100-millimeter line ranging from 0 (no pain) to 100 (unbearable pain). Higher scores indicate more severe pain

Trial sites (1)

Facility	City	Region	Status
Mugla Sitki Kocman University	Muğla	Turkey (Türkiye)

Other trials for the same condition

Analgesic Consumption in the Early Postoperative Period: A Prospective Observational PACU Study Recruiting

VNOTES and Vaginal Hysterectomy for Benign Indications Starting soon

vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626684 on ClinicalTrials.gov ↗ ← All trials in Turkey