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Recruiting Not applicable

Hot Compress Application in Open Abdominal Surgery

NCT06888154 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-05-15
Last updated
2025-10-06

Condition(s) studied

Abdominal Surgery by Laparotomy

Investigational drug(s) / intervention(s)

compress application with heated saline

compress application with heated saline: Covering intestines with sterile gauze soaked in 36°C heated saline during surgery to prevent drying and reduce infection risk

Study summary

This study aims to evaluate the effect of hot compress application to the intestines during abdominal surgery on postoperative nausea-vomiting and bowel function.

Volunteers will be randomly assigned to the intervention and control groups. Initially, 30 patients will be included in each group, and the study will be completed based on the effect size determined by power analysis.

Hypotheses:

H0: Covering the intestines with saline heated at 36°C during surgery has no effect on postoperative nausea and vomiting.

H1: Covering the intestines with saline heated at 36°C during surgery affects postoperative nausea and vomiting.

H01: Covering the intestines with saline heated at 36°C during surgery has no effect on postoperative bowel function.

H11: Covering the intestines with saline heated at 36°C during surgery affects postoperative bowel function.

Inclusion Criteria:

Undergoing abdominal surgery in the general surgery ward, Aged 18 years or older, Having a BMI between 18.50-24.99 kg/m², Able to communicate verbally, Willing to participate in the study, Conscious and oriented patients.

Exclusion Criteria:

History of previous gastrointestinal surgery, Postoperative complications, History of small bowel resection, ileostomy, or colostomy, History of emergency surgery, neoadjuvant therapy, appendectomy, or inflammatory bowel disease, Chronic opioid use, Chronic constipation (≤ 2 bowel movements per week), History of abdominal radiotherapy, Admission to the intensive care unit or postoperative bleeding.

Application:

Intervention Group: Routine preoperative procedures will be performed. During surgery, the intestines will be covered with sterile gauze soaked in saline heated at 36°C to prevent drying and reduce the risk of infection. Routine postoperative procedures will also be applied.

Control Group: Routine preoperative, intraoperative, and postoperative procedures will be applied. During surgery, the intestines will be covered with sterile gauze soaked in unheated saline, following standard practice.

Outcome Measures:

Primary Outcome: Gastrointestinal function assessment index, including time to first flatulence, first defecation, first normal bowel sounds, and first consumption of liquid/semi-solid food.

Secondary Outcome: Gastrointestinal symptoms such as nausea, abdominal bloating, pain, and vomiting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Abdominal surgery in the general surgery ward * 18 years of age or older * Patients with BMI in the normal range (18.50-24.99 kg/m2) * Able to communicate verbally * Those who volunteered to participate in the study * Patients with no mental confusion, conscious and oriented will be included. Exclusion Criteria: * Previous gastrointestinal system surgery * Complications in the postoperative period * History of small bowel resection and ileostomy or colostomy * Surgical history of inflammatory bowel diseases, emergency surgery, neoadjuvant therapy, appendectomy, * Chronic opioid use, * Experiencing chronic constipation (≤ 2 bowel movements per week), * Abdominal radiotherapy * Patients admitted to intensive care unit and patients with bleeding will not be included in the study.

Primary outcome measure(s)

  • will be an index of gastrointestinal functional assessment, including time to first passing gas, first defecation, first normal bowel sounds and first consumption of liquid/semi-general diet foods — postoperative 1-3 day
    Quality of Recovery-15 (QoR-15) Scale Scores: The QoR-15 scale is a validated tool used to assess postoperative recovery quality. It consists of 15 items, each scored on a 0-10 scale, with a total score range of 0 to 150 (higher scores indicate better recovery). Scoring Interpretation: 0 - 70 → Poor recovery 71 - 100 → Moderate recovery 101 - 150 → Good recovery Gastrointestinal Symptom Rating Scale (GSRS) - Scale Scores The Gastrointestinal Symptom Rating Scale (GSRS) is a validated tool used to assess the severity of gastrointestinal (GI) symptoms. It consists of 15 items, each scored on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort). Scoring Interpretation: Total Score Range: 15 to 105 (higher scores indicate worse GI symptoms). Mean score calculation: Total score is divided by the number of items (15) to determine the severity of symptoms. Interpretation of Scores: 15 - 30 → Mild symptoms 31 - 60 → Moderate symptoms 61 - 105 → Severe symptoms

Trial sites (1)

FacilityCityRegionStatus
Kırşehir Ahi Evran University Merkez Kırşehir 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 NCT06888154 on ClinicalTrials.gov ↗ ← All trials in Turkey