An interventional study of compress application with heated saline in Abdominal Surgery by Laparotomy, sponsored by TC Erciyes University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Supportive care
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.
DATA COLLECTION Patient Introduction Form (ANNEX-1) and Patient Follow-up Form (ANNEX-2), Healing Quality-15 Scale (ANNEX-3) and Gastrointestinal Symptom Rating Scale (ANNEX-4), which were created by the researchers by reviewing the literature will be used for data collection.
Patient Introduction Form:
The Patient Information Form, which was created by the researchers by reviewing the literature includes questions about age, gender, medical diagnosis, educational status, BMI, chronic disease, medication used continuously, previous surgery, and frequency of defecation.
Patient Follow-up Form:
The Patient Introduction Form, which was created by the researchers by reviewing the literature , consists of 3 sections including preoperative, intraoperative and postoperative. In the preoperative section, preoperative lab. findings, preoperative fasting time (hours), type and amount of IV fluid given preoperatively; In the intraoperative section, surgical method, amount of fluid given in surgery, duration of surgery (min), fluid given in surgery, blood transfusion administration in surgery; In the postoperative section, laboratory findings, blood transfusion, presence of drain, pain, serum administered postoper
Quality Of Recovery-15 Scale/Quality Of Recovery-15 (QoR-15):
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).
Gastrointestinal Symptom Rating Scale The GDSS (Gastrointestinal Symptom Rating Scale) is a 15-item, 7-point Likert-type scale with options ranging from "no discomfort" to "very severe discomfort".
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
TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will be toweled with heated saline during abdominal surgery. After the abdomen is opened, the intestines will be covered with a sterile towel soaked in saline heated to 36°C to prevent drying and reduce the risk of infection.
Other: compress application with heated saline
Patients in this group will receive standard surgical care.
Covering intestines with sterile gauze soaked in 36°C heated saline during surgery to prevent drying and reduce infection risk
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
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
Time frame: postoperative 1-3 day
Plan to share: No
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