Clinical trial NCT04429425: Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?
Official title: A Prospective Randomized Comparative Study of Effectiveness of Epidural Anesthesia to Reduce Postoperative Ileus in Patients Undergoing Colorectal Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Disorders
Postoperative Ileus
Keywords: colorectal surgery
postoperative ileus
epidural anesthesia
enhanced recovery after surgery
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: each patient will be randomly asigned to each group (EA or non-EA)
Primary purpose: PREVENTION

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.

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,

Primary outcomes:
measure: postoperative ileus
timeFrame: up to 4 days
measure: prolonged postoperative ileus
timeFrame: up to 10 days
Secondary outcomes:
measure: hospital stay
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yazici
state: Other
Study officials:
affiliation: sisli etfal training and research hospital
name: pinar yazici
role: PRINCIPAL_INVESTIGATOR
References: