Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

A Prospective Randomized Comparative Study of Effectiveness of Epidural Anesthesia to Reduce Postoperative Ileus in Patients Undergoing Colorectal Surgery.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Disorders; Postoperative Ileus
• Intervention / Treatment: Procedure: epidural anesthesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Other
    • Istanbul, Other, Turkey, 34317
      • Pinar Yazici

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: EA group; patients with colorectal surgery that willl be performed epidural anesthesia	Procedure: epidural anesthesia; epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid
NO_INTERVENTION: non -EA group; patients with colorectal surgery that willl be performed only general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 4 days
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.	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay	time from the day of surgery to day of discharge	up to 1 year

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: pinar yazici, Sisli Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2022
• Primary Completion (ANTICIPATED): September 10, 2023
• Study Completion (ANTICIPATED): December 10, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: colorectal surgery; postoperative ileus; enhanced recovery after surgery; epidural anesthesia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CT-EPI-CRS-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No