Completed

The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial

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What is being tested

rubber water bag

Other
Who is being recruted

From 18 to 90 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorErzincan Military Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 5, 2021

Actual date on which the first participant was enrolled.

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 \[18\].

Official TitleThe Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial
Principal SponsorErzincan Military Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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.

13 exclusion criteria prevent from participating
ASA score >3,

chronic constipation (defined as ≤2 bowel movements per week),

inflammatory bowel disease,

irritable bowel syndrome,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, Turkey (Türkiye)Open Mugla Sıtkı Kocman University Education and Research Hospital in Google Maps
CompletedOne Study Center