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Effect of Abdominal Ice Pack After vNOTES Hysterectomy

NCT07626684 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-06-04

No results posted yet for this 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

Conditions

  • Hysterectomy, Benign Uterine Diseases
  • Hysterectomy, Vaginal
  • vNOTES
  • Postoperative Pain Following Hysterectomy
  • Patient Comfort and Safety
  • Bowel Functions
  • Analgesic Consumption

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Erzincan Military Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-02-15
Completion
2027-03-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626684 on ClinicalTrials.gov