A Multimodal Enhanced Recovery Program in Anorectal Surgery (ARSE)

August 24, 2020 updated by: Columbia University

A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery

The goal of this study is to establish whether an opioid-sparing Enhanced Recovery After Surgery (ERAS) program in ambulatory anorectal surgery can be safely introduced at a single tertiary referral center without an increase in postoperative pain or negative impact on the patient experience. A single-center, single-blinded randomized control trial is proposed, where patients will be assigned in a 1:1 ratio to either usual care, which includes extended opioids (control group) or the enhanced recovery group (experimental), which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods. The expected outcome is that the enhanced recovery program will significantly reduce opioid utilization with comparable pain scores and patient satisfaction after anorectal surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

There is an opioid epidemic in the United States, and the epidemic continues to worsen. The rate of opioids prescribed, distributed, and deaths from opioid overdoses continue to increase steadily. Opioids also have the costs of abuse, dependence, diversion of unused medication, and can serve as a gateway to other illegal substances. Opioid use often begins with treatment of acute postoperative pain, and the surgical episode can be a 'gateway' to the opioid crisis. Opioids remain ubiquitous in patients undergoing surgical procedures. Among opioid-naïve patients, persistent use after surgery occurs in 6-10%.

Ambulatory surgery cases are rarely mentioned in the context of this public health crisis, but are a major contributor to the problem. Opioids are ubiquitous after ambulatory anorectal surgery and prescribed in large quantities, often several times more than what is needed or taken by patients. As patients take a fraction of the opioids prescribed, this adds to issues of opioid diversion. In colorectal surgery, ambulatory anorectal procedures are common and frequent procedures, with the potential to impact a large number of patients when implementing quality improvement. Thus, study into ERAS and ways to reduce opioids after ambulatory anorectal surgery is warranted.

This application challenges the notion that inpatient surgery should be the only target for enhanced recovery and opioid interventions. It seeks to shift the clinical practice paradigm that extended opioids are necessary after ambulatory anorectal surgery. This new application of ERAS to ambulatory anorectal surgery could address a critical barrier to progress in reducing opioids in procedures that are common but underrepresented in current research.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in whom surgery is planned via an anorectal approach for hemorrhoids, fissures, or fistula disease.

Exclusion Criteria:

  • Patients are not eligible if currently or chronically (more than 7 days prior to presentation) on opioid medication or opioid-receptor antagonist medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
Experimental: Experimental
The experimental group will receive routine directions for surgery and a ReCOVER patient education document on the Enhanced Recovery protocol, with instructions on preoperative preparation, postoperative wound care, pain management, preventing and managing constipation, activity limitations, and return precautions. The information sheet will be provided to patients in clinic and reviewed with a member of the healthcare team to ensure an understanding of the plan.
Procedure: ReCOVER Enhanced Recovery Protocol
The experimental group will receive preemptive pain management before surgery, an opioid-free strategy during surgery, and an opioid-sparing multimodal pain management protocol after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Opioid Use
Time Frame: Up to 30 days post surgery
Postoperative opioid use will be measured in morphine milligram equivalents per day (MME)
Up to 30 days post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on the Visual Analog Scale (VAS)
Time Frame: Up to 30 days post surgery
A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain (score of 0) and the other end meaning the worst pain imaginable (score of 100). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Up to 30 days post surgery
Pain Score on the Functional Pain Scale (FPS)
Time Frame: Up to 30 days post surgery
The Functional Pain Scale (FPS) was developed in 2001 to evaluate the effect of pain on patient function for various different types of pain. The scale ranges from 0-5 and the participants score will fall within this range 0-5 range based a combination of their subjective rating of pain and their objective opinion about how that pain interferes with daily activities. A lower score is linked to lower levels of pain and reduced interference from pain on daily activities.
Up to 30 days post surgery
Score on the EQ-5D-3L
Time Frame: Up to 30 days post surgery
The EQ-5D-3L queries across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has levels ranging from no problems (score of 1) to extreme problems (score of 5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The final "score" is coded based on the 5 responses.
Up to 30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Deborah S. Keller, MS, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Actual)

May 21, 2020

Study Completion (Actual)

May 21, 2020

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS3302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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