Postoperative IleusNCT04833699
The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies
A study testing rubber water bag in people with Postoperative Ileus, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. [1]. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- rubber water bag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patiens aith aged ≥18 years olds
- patients undergoing elective exhaustive staging surgery (total hysterectomy (Type A-C2), systematic pelvic para-aortic lymphadenectomy ± bilateral salpingo-oophorectomy and ± omentectomy by abdominal approach containing either open or laparoscopic surgery.
Who cannot join
- ASA score >3,
- chronic constipation (defined as ≤2 bowel movements per week),
- inflammatory bowel disease,
- irritable bowel syndrome,
- compromised liver function,
- clinically significant cardiac arrhythmia,
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- Thyroid disorder,
- History of abdominal bowel surgery,
- previous abdominal irradiation,
- previous neoadjuvant chemotherapy or hyperthermic intraperitoneal chemotherapy,
- Performed upper abdominal surgery
- The covid-19 positive test result,
- bowel anastomosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Education and Research Hospital
Muğla, 48000
About this study
Official title: The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial
Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. [1]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization [1]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers.
Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI [1-3]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications [4-6]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan [7-15]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery.
Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain [16]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin [17]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain-producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine [18].
- Conditions
- Postoperative Ileus
- Being tested
- rubber water bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rubber water bagOther
bboiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group A or the control group did not pick up any therapy except our clinical standard postoperative care (ERAS protocol) |
| Study | Experimental | Group B served as the hot pack group boiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol). Receives: Other: rubber water bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first passage of flatus after surgery
Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant.
Measured: up to 72 hours
Secondary outcomes (2)
The time to tolerate a solid diet
The time to tolerate a solid diet was measured from the end of operation, referred to the time when the patient awoke from anesthesia, until the patient tolerated intake of solid food (any food that required chewing) without vomiting
Measured: Up to 5 days
The time to the first bowel movement
The time to the first bowel movement was referred to the time to the first audible bowel sound during routine postoperative care. Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start5 Apr 2021
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833699
- Sponsor's protocol ID
- MUGLA-3
- Status last verified
- Sep 2023
- First submitted
- 27 Mar 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gungorduk K, Selimoglu B, Gulseren V, Yasar E, Comba C, Ozdemir IA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116. doi: 10.1002/ijgo.15181. Epub 2023 Oct 6.
PubMed 37800343
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04833699
- Acronym / sponsor ID
- MUGLA-3
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 6 Apr 2021 (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.
Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. [1]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization [1]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers.
Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI [1-3]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications [4-6]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan [7-15]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery.
Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain [16]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin [17]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain-producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine [18].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group A or the control group did not pick up any therapy except our clinical standard postoperative care (ERAS protocol) |
| Study | Experimental | Other: rubber water bagGroup B served as the hot pack group boiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patiens aith aged ≥18 years olds
- patients undergoing elective exhaustive staging surgery (total hysterectomy (Type A-C2), systematic pelvic para-aortic lymphadenectomy ± bilateral salpingo-oophorectomy and ± omentectomy by abdominal approach containing either open or laparoscopic surgery.
Key exclusion criteria (13 listed)
- ASA score >3,
- chronic constipation (defined as ≤2 bowel movements per week),
- inflammatory bowel disease,
- irritable bowel syndrome,
- compromised liver function,
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 |
|---|---|---|
| rubber water bagbboiled tap water (80 °C) was put in a rubber water bag with a fluffy cover (Fig. 1), and placed on the patient's abdomen at 3, 6, 9, and 12 h after the surgical procedure for 30 minutes in addition to clinical standard postoperative care (ERAS protocol) | Other | Study |
Primary outcome
time to the first passage of flatus after surgery
Time frame: up to 72 hours
Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant.
2 secondary outcomes
The time to tolerate a solid diet
Time frame: Up to 5 days
The time to the first bowel movement
Time frame: up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 37800343Gungorduk K, Selimoglu B, Gulseren V, Yasar E, Comba C, Ozdemir IA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116. doi: 10.1002/ijgo.15181. Epub 2023 Oct 6.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rubber water bag in people with Postoperative Ileus, run by Erzincan Military Hospital 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 7 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to the first passage of flatus after surgery (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833699, which also lists 1 linked publication.
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 7 Sep 2023.