Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

NCT04429425 | Unknown

• 1 other identifier: CT-EPI-CRS-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Disorders; Postoperative Ileus

Keywords

colorectal surgery; postoperative ileus; epidural anesthesia; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• hospital stay

  up to 1 year

Study Arms (2)

EA group

OTHER

patients with colorectal surgery that willl be performed epidural anesthesia

Procedure: epidural anesthesia

non -EA group

NO INTERVENTION

patients with colorectal surgery that willl be performed only general anesthesia

Interventions

epidural anesthesia PROCEDURE

epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid

EA group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing colorectal surgery due to both benign and malign disorders
• no contraindication for epidural anesthesia

You may not qualify if:

• 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,

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Pinar Yazici

Istanbul, Other, 34317, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• pinar yazici

  sisli etfal training and research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: all patients undergoing colorectal surgery will be grouped consecutively as epidural anesthesia (EA) or non-EA
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: each patient will be randomly asigned to each group (EA or non-EA)

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: June 12, 2020
• Study Start: March 10, 2022
• Primary Completion: September 10, 2023
• Study Completion: December 10, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

TU (1)