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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04429425
Enrollment
100
Registered
2020-06-12
Start date
2022-03-10
Completion date
2023-12-10
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders, Postoperative Ileus

Keywords

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

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.

Interventions

PROCEDUREepidural anesthesia

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

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

all patients undergoing colorectal surgery will be grouped consecutively as epidural anesthesia (EA) or non-EA

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
postoperative ileusup to 4 daysobstipation 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
prolonged postoperative ileusup to 10 daysinability 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.

Secondary

MeasureTime frameDescription
hospital stayup to 1 yeartime from the day of surgery to day of discharge

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026