Effect of Abdominal Ice Pack After vNOTES Hysterectomy

May 31, 2026 updated by: Kemal GUNGORDUK, Erzincan Military Hospital

The Effect of Abdominal Ice Pack on Postoperative Pain, Bowel Motility, and Patient Comfort Following vNOTES Hysterectomy

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Abdominal Ice Pack Group
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
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.
No Intervention: Standard Control Group
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: 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
Postoperative 2nd, 6th, 12th, and 24th hours, and postoperative 2nd and 6th weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Rescue Analgesic Consumption
Time Frame: During the first 24 hours postoperatively
Total doses of rescue diclofenac or tramadol administered will be documented in milligrams.
During the first 24 hours postoperatively
Postoperative Quality of Life
Time Frame: Postoperative Day 1
Measured using the 15-item Quality of Recovery questionnaire (total score ranges from 0-150 )
Postoperative Day 1
Postoperative Gastrointestinal Function
Time Frame: Through hospital discharge, up to 3 days
Monitored using the standardized I-FEED scoring system to evaluate bowel motility
Through hospital discharge, up to 3 days
Postoperative Surgical Satisfaction Scores
Time Frame: Postoperative Day 2 Through hospital discharge, an average of 2 days
Assessed via SSQ-8 (8 Likert items, scores 8 to 40; higher scores indicate better satisfaction)
Postoperative Day 2 Through hospital discharge, an average of 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erzincan Military Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in this article will be made available upon reasonable request

IPD Sharing Time Frame

Beginning 3 months following article publication and ending 5 years after publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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