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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04833699
Other study ID # MUGLA-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2021
Est. completion date April 30, 2023

Study information

Verified date September 2023
Source Erzincan Military Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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]. 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].


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date April 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
rubber water bag
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)

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Education and Research Hospital Mugla

Sponsors (1)

Lead Sponsor Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 72 hours
Secondary 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 Up to 5 days
Secondary 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. up to 72 hours
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