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A Multimodal Enhanced Recovery Program in Anorectal Surgery (ARSE)

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ClinicalTrials.gov Identifier: NCT03992079
Recruitment Status : Terminated (PI is no longer at institution)
First Posted : June 20, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Anorectal Disorder Patient Satisfaction Pain, Postoperative Opioid Use Opioid Abuse Opioid Dependence Procedure: ReCOVER Enhanced Recovery Protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After providing written informed consent, patients will be randomly assigned in a 1:1 ratio to either the control group, which uses physician preference for pain control, and generally relies on extended opioids or the experimental group, which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods.
Masking: Double (Care Provider, Investigator)
Masking Description: Randomization will be conducted by means of a secure website (Sealed Envelope), with block randomization to help balance the groups by the procedures performed within each arm. The patients, post-anesthesia care unit (PACU) staff, and study investigators performing follow up assessments, collecting, and analyzing the data will be unaware of the treatment assignments. It is not feasible to blind the operating team or site enrolment personnel as different preoperative and discharge information, medication and patient education will be given to the experimental and control groups. A numbered, sealed envelope, corresponding to the patient's assigned study number, will be opened, and the research coordinator will alert the surgeon to the patient's group assignment. Using the assumption that patients do not know the difference between enhanced recovery and usual care, the patient will not be informed of which arm they are assigned to.
Primary Purpose: Treatment
Official Title: A Single Institutional Randomized Controlled Trial for A Multimodal Enhanced Recovery Program in Anorectal Surgery
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : May 21, 2020
Actual Study Completion Date : May 21, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992079


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Deborah S. Keller, MS, MD Columbia University
Additional Information:
Publications:

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT03992079    
Other Study ID Numbers: AAAS3302
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Diseases
Disease
Pain, Postoperative
Opioid-Related Disorders
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases