Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?
Primary Purpose
Colorectal Disorders, Postoperative Ileus
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
epidural anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Disorders focused on measuring colorectal surgery, postoperative ileus, epidural anesthesia, enhanced recovery after surgery
Eligibility Criteria
Inclusion Criteria:
- undergoing colorectal surgery due to both benign and malign disorders
- no contraindication for epidural anesthesia
Exclusion Criteria:
- drug use (psychotropic drugs etc) that may cause paralytic ileus
- immobile patients that ERAS protocol can not be applied on
- Anticoagulated patients with the risk of epidural hematoma,
Sites / Locations
- Pinar Yazici
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
EA group
non -EA group
Arm Description
patients with colorectal surgery that willl be performed epidural anesthesia
patients with colorectal surgery that willl be performed only general anesthesia
Outcomes
Primary Outcome Measures
postoperative ileus
obstipation and intolerance of oral intake due to nonmechanical factors that disrupt propulsive activity of the gastrointestinal system following colorectal surgery..Obstipation was defined as abdominal distention or/and pain at physical examination and difficulty passing gas postoperatively. Intolerance of oral intake was defined as nause or vomiting associated with food intake
prolonged postoperative ileus
inability to tolerate oral intake, two or more of nause/ vomiting requiring cessation of oral diet or/and nasogastric decompression and intravenous support, and absence of flatus prolonging hospitalization beyond discharge goal..Prolonged PO was defined as by the postoperative day 5, in case of persistent symptoms mentioned above and radiological confirmation of ileus on plain abdominal film showing multiple distended loops with air and/or fluid and air in both small intestines and large intestines.
Secondary Outcome Measures
hospital stay
time from the day of surgery to day of discharge
Full Information
NCT ID
NCT04429425
First Posted
March 17, 2020
Last Updated
May 5, 2022
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04429425
Brief Title
Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?
Official Title
A Prospective Randomized Comparative Study of Effectiveness of Epidural Anesthesia to Reduce Postoperative Ileus in Patients Undergoing Colorectal Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The use of epidural analgesia (EA) has been suggested as an integral part of an enhanced recovery program for colorectal surgery. However, the effects of EA on postoperative ileus remain controversial. Some authors suggest that EA has beneficial effects for postoperative outcome and hospital stay, whereas others have reported that the role of EA in the modern perioperative care of patients undergoing open colorectal surgery has been limited. Therefore, the investigators aimed to investigate the effect of EA on postoperative outcome, particularly postoperative ileus and hospital stay in patients with colorectal surgery.
Detailed Description
In 2016, results of Cochrane review of 22 trials on the efficacy of EA in patients undergoing abdominal surgery showed that an epidural containing a local anesthetic, with or without the addition of an opioid, accelerated the return of gastrointestinal transit (high quality of evidence) and no difference in the incidence of vomiting or anastomotic leak (low quality of evidence). For open surgery, an epidural containing a local anaesthetic would reduce the length of hospital stay (very low quality of evidence).
However, in a recent analysis from American College of Surgeons revealed that the use of EA did not improve postoperative recovery after elective colectomy in their analysis and was associated with increased postoperative ileus and prolonged hospital stay after open colectomy.
In this study, the investigators aimed to compare the efficacy of EA to reduce the postoperative ileus and hospital stay, as well in the patients undergoing colorectal surgery. This prospective randomized study planned to include 100 consecutive patients with colorectal disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Disorders, Postoperative Ileus
Keywords
colorectal surgery, postoperative ileus, epidural anesthesia, enhanced recovery after surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
each patient will be randomly asigned to each group (EA or non-EA)
Masking
None (Open Label)
Masking Description
all patients undergoing colorectal surgery will be grouped consecutively as epidural anesthesia (EA) or non-EA
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EA group
Arm Type
Other
Arm Description
patients with colorectal surgery that willl be performed epidural anesthesia
Arm Title
non -EA group
Arm Type
No Intervention
Arm Description
patients with colorectal surgery that willl be performed only general anesthesia
Intervention Type
Procedure
Intervention Name(s)
epidural anesthesia
Intervention Description
epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid
Primary Outcome Measure Information:
Title
postoperative ileus
Description
obstipation and intolerance of oral intake due to nonmechanical factors that disrupt propulsive activity of the gastrointestinal system following colorectal surgery..Obstipation was defined as abdominal distention or/and pain at physical examination and difficulty passing gas postoperatively. Intolerance of oral intake was defined as nause or vomiting associated with food intake
Time Frame
up to 4 days
Title
prolonged postoperative ileus
Description
inability to tolerate oral intake, two or more of nause/ vomiting requiring cessation of oral diet or/and nasogastric decompression and intravenous support, and absence of flatus prolonging hospitalization beyond discharge goal..Prolonged PO was defined as by the postoperative day 5, in case of persistent symptoms mentioned above and radiological confirmation of ileus on plain abdominal film showing multiple distended loops with air and/or fluid and air in both small intestines and large intestines.
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
hospital stay
Description
time from the day of surgery to day of discharge
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
undergoing colorectal surgery due to both benign and malign disorders
no contraindication for epidural anesthesia
Exclusion Criteria:
drug use (psychotropic drugs etc) that may cause paralytic ileus
immobile patients that ERAS protocol can not be applied on
Anticoagulated patients with the risk of epidural hematoma,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pinar yazici
Organizational Affiliation
sisli etfal training and research hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinar Yazici
City
Istanbul
State/Province
Other
ZIP/Postal Code
34317
Country
Turkey
12. IPD Sharing Statement
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Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?
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