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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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." |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Rescue Analgesic Consumption | Total doses of rescue diclofenac or tramadol administered will be documented in milligrams. | During the first 24 hours postoperatively |
| Postoperative Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
Only female participants who are scheduled to undergo benign or premalignant gynecological indications for vNOTES hysterectomy are eligible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mugla Sitki Kocman University | Muğla | 48000 | Turkey (Türkiye) |
De-identified individual participant data that underlie the results reported in this article will be made available upon reasonable request
Beginning 3 months following article publication and ending 5 years after publication.
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
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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.
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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.
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Measured using the 15-item Quality of Recovery questionnaire (total score ranges from 0-150 )
| Postoperative Day 1 |
| Postoperative Gastrointestinal Function | Monitored using the standardized I-FEED scoring system to evaluate bowel motility | Through hospital discharge, up to 3 days |
| Postoperative Surgical Satisfaction Scores | 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 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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