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

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    130
  • sponsor
    Erzincan Military Hospital
Updated on 27 October 2022

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].

Only one study has shown that hot pack therapy at the postoperative period has a positive effect on bowel motility. However, this study has a lot of weaknesses. Moreover, until now, no study has specifically investigated the effect of the hot pack on gynecological oncology surgery. The investigators hypothesized that using a hot pack during the early postoperative period would accelerate the return of gastrointestinal motility. Therefore, investigators performed a randomized controlled trial (RCT) to assess whether using hot pack whips up the recovery of gut function after gynecological oncology surgery

Details
Condition Postoperative Ileus
Treatment rubber water bag
Clinical Study IdentifierNCT04833699
SponsorErzincan Military Hospital
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
a thyroid disorder
a history of abdominal bowel surgery
previous abdominal irradiation
previous neoadjuvant chemotherapy or hyperthermic intraperitoneal chemotherapy
the use of an upper abdominal multi-visceral surgical approach for debulking surgery
The covid-19 positive test result
early post-operative complications in the first week after surgery (re-laparotomy, massive blood transfusion)
a need for intensive care for >24 hours post-operatively
bowel anastomosis
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