The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- time to the first passage of flatus after surgery
Study Overview
Brief 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]. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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,
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The time to the first bowel movement(up to 72 hours)
- The time to tolerate a solid diet(Up to 5 days)
Investigators
Kemal GUNGORDUK
KG
Muğla Sıtkı Koçman University