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

NCT04833699 | Completed

• 1 other identifier: MUGLA-3
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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 \[18\].

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The time to tolerate a solid diet

  Up to 5 days

• The time to the first bowel movement

  up to 72 hours

Study Arms (2)

Control

NO INTERVENTION

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

Study

EXPERIMENTAL

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).

Other: rubber water bag

Interventions

rubber water bag OTHER

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)

Study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

• Gungorduk K, Selimoglu B, Gulseren V, Yasar E, Comba C, Ozdemir IA. Effect of abdominal hot pack application on gastrointestinal motility recovery after comprehensive gynecologic staging surgery. Int J Gynaecol Obstet. 2024 Mar;164(3):1108-1116. doi: 10.1002/ijgo.15181. Epub 2023 Oct 6.

  PMID: 37800343 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KG

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 6, 2021
• Study Start: April 5, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)