The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies

Erzincan Military Hospital

Status: Completed

Conditions: Postoperative Ileus

Treatments: Other: rubber water bag

Study type: Interventional

Funder types: Other

Identifiers

NCT04833699

MUGLA-3

Details and patient eligibility

About

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].

Enrollment: 130 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Control

No Intervention group

Description:

Group A or the control group did not pick up any therapy except our clinical standard postoperative care (ERAS protocol)

Study

Experimental group

Description:

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).

Treatment:

Other: rubber water bag