Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04429425
• Other study ID #: CT-EPI-CRS-2020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: May 2022
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 10, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Colorectal Disorders
• Ileus
• Postoperative Ileus

Intervention

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

Locations

Country	Name	City	State
Turkey	Pinar Yazici	Istanbul	Other

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	hospital stay	time from the day of surgery to day of discharge	up to 1 year