Effect of Abdominal Ice Pack After vNOTES Hysterectomy

NCT07626684 | Enrolling By Invitation

• 1 other identifier: M09
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Postoperative Pain; vNOTES Hysterectomy; Gastrointestinal Motility; Patient Comfort; Abdominal Ice Pack

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores

  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

  Postoperative 2nd, 6th, 12th, and 24th hours, and postoperative 2nd and 6th weeks.

Secondary Outcomes (4)

• Total Rescue Analgesic Consumption

  During the first 24 hours postoperatively

• Postoperative Quality of Life

  Postoperative Day 1

• Postoperative Gastrointestinal Function

  Through hospital discharge, up to 3 days

• Postoperative Surgical Satisfaction Scores

  Postoperative Day 2 Through hospital discharge, an average of 2 days

Study Arms (2)

Abdominal Ice Pack Group

ACTIVE COMPARATOR

Patients receive abdominal ice pack therapy plus standard Enhanced Recovery After Surgery (ERAS) protocol after vNOTES hysterectomy. Ice application begins upon ward transfer after clinical stabilization. Ice cubes sealed in a 30x40 cm zipped bag inside a pillowcase are placed directly on the lower abdomen (symphysis pubis to umbilicus, between anterior superior iliac spines). One or two ice packs are applied for 20 minutes every 2 hours during the first 24 hours postoperatively. Standard ERAS care includes no bowel preparation, low-molecular-weight heparin, general anesthesia, orogastric tube, and a Foley catheter removed at the 8th postoperative hour. Postoperative pain is tracked via Visual Analog Scale (VAS) and Face Pain Index. If VAS is ≥4, rescue diclofenac is given; if ≥6, intravenous tramadol is administered."

Procedure: Abdominal Ice Pack + ERAS

Standard Control Group

NO INTERVENTION

Patients receive the standard institutional Enhanced Recovery After Surgery (ERAS) protocol care alone, with absolute exclusion of any abdominal ice pack application or cryotherapy after vNOTES hysterectomy. Management adheres strictly to the standard clinical pathway without any physical interventions on the abdominal wall. ERAS care includes no preoperative mechanical bowel preparation, low-molecular-weight heparin prophylaxis, standard general anesthesia, intraoperative gastric decompression via orogastric tube, and a Foley catheter removed at the 8th postoperative hour. Pain is evaluated at the 2nd, 6th, 12th, 24th hours, and weeks 2 and 6 using the Visual Analog Scale (VAS) and Face Pain Index. Identical rescue analgesia is enforced: rescue diclofenac for VAS ≥ 4, and intravenous tramadol for VAS ≥6

Interventions

Abdominal Ice Pack + ERAS PROCEDURE

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.

Abdominal Ice Pack Group

Eligibility Criteria

• Age: 48 Years - 70 Years
• Gender Eligibility Details: Only female participants who are scheduled to undergo benign or premalignant gynecological indications for vNOTES hysterectomy are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention (abdominal ice pack application), patients and healthcare providers administering the therapy cannot be masked to group allocation. However, to minimize measurement bias, clinical assessments will be performed using standardized scales. Additionally, objective evaluations such as the Face Pain Index will be recorded by ward physicians or nurses who are not directly involved in the daily implementation of the ice therapy protocol. To prevent selection bias, group allocation and randomization will be performed strictly postoperatively, only after the patient achieves clinical stabilization upon arrival at the ward.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Arm 1: Experimental Arm Title: Abdominal Ice Pack Group Arm Description: Patients in this group will receive standard postoperative care according to the ERAS protocol, with the addition of abdominal ice pack application. Arm 2: Active Comparator Arm Title: Control Group Arm Description: Patients in this group will receive standard postoperative care according to the ERAS protocol alone, without any ice application.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months following article publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

TU (1)