Clinical trial NCT04833699: The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies
Official title: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 \[18\].


Eligibility criteria: 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.

Primary outcomes:
measure: time to the first passage of flatus after surgery
timeFrame: up to 72 hours
Secondary outcomes:
measure: The time to tolerate a solid diet
timeFrame: Up to 5 days
measure: The time to the first bowel movement
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Education and Research Hospital
Study officials:
References: