Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

NCT01844908

Postoperative Ileus

UNKNOWN NA

Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery

NCT00464425

Postoperative Ileus

COMPLETED PHASE3

Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

NCT04090073

Postoperative Ileus

UNKNOWN NA

Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

NCT02059603

Postoperative Ileus

UNKNOWN PHASE3

Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus

NCT02399605

Ileus

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Disorders Postoperative Ileus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EA group

patients with colorectal surgery that willl be performed epidural anesthesia

Group Type OTHER

epidural anesthesia

Intervention Type PROCEDURE

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

non -EA group

patients with colorectal surgery that willl be performed only general anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

epidural anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No