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Clinical Trials/NCT04429425
NCT04429425
Unknown
N/A

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

Sisli Hamidiye Etfal Training and Research Hospital1 site in 1 country100 target enrollmentMarch 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Disorders
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
prolonged postoperative ileus
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2022
End Date
December 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Pinar Yazici

Assoc Prof

Sisli Hamidiye Etfal Training and Research Hospital

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,

Outcomes

Primary Outcomes

prolonged postoperative ileus

Time Frame: up to 10 days

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.

postoperative ileus

Time Frame: up to 4 days

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

Secondary Outcomes

  • hospital stay(up to 1 year)

Study Sites (1)

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