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

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rubber water bag
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept 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,
  • 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.

Sites / Locations

  • Mugla Sıtkı Kocman University Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Study

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The time to tolerate a solid diet
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
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.

Full Information

First Posted
March 27, 2021
Last Updated
September 4, 2023
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04833699
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Group A or the control group did not pick up any therapy except our clinical standard postoperative care (ERAS protocol)
Arm Title
Study
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
rubber water bag
Intervention Description
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)
Primary Outcome Measure Information:
Title
time to the first passage of flatus after surgery
Description
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.
Time Frame
up to 72 hours
Secondary Outcome Measure Information:
Title
The time to tolerate a solid diet
Description
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
Time Frame
Up to 5 days
Title
The time to the first bowel movement
Description
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.
Time Frame
up to 72 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Education and Research Hospital
City
Mugla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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