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. . This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization . 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 . It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin . 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 . 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
Full Title of Study: “The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: December 30, 2022
- Other: rubber water bag
- hot pack group that 1200 cc warm water (50-550 c) was put in a rubber water bag (Fig 1) and then covered with a cloth and placed on the patients umbilicus at 6, 12, and 18 h after the operation for 30 minutes in addition to clinical standard postoperative care.
Arms, Groups and Cohorts
- No Intervention: Control
- Group A served as the control group who did not receive any intervention except our clinical standard postoperative care
- Experimental: Study
- Group B served as the hot pack group that warm water (80 C) was put in a hot pack (Fig 1) and then placed on the patients umbilicus at 6, 12, and 18 h after the operation for 45 minutes in addition to clinical standard postoperative care.
Clinical Trial Outcome Measures
- 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.
- The time to tolerate a solid diet
- Time Frame: Up to 7 days
- 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
- The time to the first bowel movement
- Time Frame: up to 72 hours
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Erzincan Military Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Kemal GUNGORDUK, KG – Muğla Sıtkı Koçman University
- Overall Contact(s)
- Kemal Güngördük, MD, 05057465266, email@example.com
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