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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04429425
Other study ID # CT-EPI-CRS-2020
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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
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