Abdominal Surgery by LaparotomyHotCompressNCT06888154
Hot Compress Application in Open Abdominal Surgery
A study testing compress application with heated saline in people with Abdominal Surgery by Laparotomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgery by Laparotomy
- What is being tested?
- compress application with heated saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırşehir Ahi Evran University
Merkez, Kırşehir
Dilek TALHAOĞLU, 05545911691, dilektalhaoglu@gmail.com
About this study
Official title: The Effect of Hot Compress Applied on the Intestines on Postoperative Nausea-vomiting and Bowel Function in Abdominal Surgery
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.
Read more
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.
Read the detailed description
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
- Conditions
- Abdominal Surgery by Laparotomy
- Being tested
- compress application with heated saline
- Keywords
- abdominal surgery, hot compress, operating room, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compress application with heated salineOther
Covering intestines with sterile gauze soaked in 36°C heated saline during surgery to prevent drying and reduce infection risk
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Hot compress Application) | Experimental | 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. Receives: Other: compress application with heated saline |
| Control Group (Routine Care) | No intervention | Patients in this group will receive standard surgical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: postoperative 1-3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start15 May 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Surgery by LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Responsible party
- Principal investigator, Dilek Talhaoglu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888154
- Sponsor's protocol ID
- hot compress
- Acronym
- HotCompress
- Status last verified
- Oct 2025
- First submitted
- 9 Mar 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Compress Applied on the Intestines on Postoperative Nausea-vomiting and Bowel Function in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06888154
- Acronym / sponsor ID
- HotCompress / hot compress
- Conditions
- Abdominal Surgery by Laparotomy
- Keywords
- abdominal surgery, hot compress, operating room, nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Hot compress Application) | Experimental | Other: compress application with heated salinePatients 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. |
| Control Group (Routine Care) | No intervention | –Patients in this group will receive standard surgical care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compress application with heated salineCovering intestines with sterile gauze soaked in 36°C heated saline during surgery to prevent drying and reduce infection risk | Other | Intervention Group (Hot compress Application) |
Primary outcome
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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compress application with heated saline in people with Abdominal Surgery by Laparotomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek TALHAOĞLU, PhD (+905545911691, dilektalhaoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: postoperative 1-3 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.