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Status unknownNCT04429425Updated May 11, 2022

Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?

An interventional study of epidural anesthesia in Colorectal Disorders and Postoperative Ileus, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Disorders
  • Postoperative Ileus

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Keywords

  • colorectal surgery
  • postoperative ileus
  • epidural anesthesia
  • enhanced recovery after surgery
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • undergoing colorectal surgery due to both benign and malign disorders
  • no contraindication for epidural anesthesia

Exclusion criteria

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,
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    EA group

    patients with colorectal surgery that willl be performed epidural anesthesia

    Procedure: epidural anesthesia

  • No intervention
    non -EA group

    patients with colorectal surgery that willl be performed only general anesthesia

Interventions

  • Procedureepidural anesthesia

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 4 days

  2. 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.

    Time frame: up to 10 days

Secondary outcomes

  1. hospital stay

    time from the day of surgery to day of discharge

    Time frame: up to 1 year

06

Study locations

1 site
  • Pinar Yazici
    Istanbul, Other 34317, Turkey
07

Registry details

Key details

Study ID
NCT04429425
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Pinar Yazici (Assoc Prof, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Jun 12, 2020
Start date
Mar 10, 2022
Primary completion
Sep 10, 2023 (estimated)
Completion
Dec 10, 2023 (estimated)
Last update
May 11, 2022

Study contacts

pinar yazici
principal investigator · sisli etfal training and research hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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