An interventional study of ReCOVER Enhanced Recovery Protocol in Colorectal Disorders, Anorectal Disorder and Patient Satisfaction, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-25.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
Among 33 studies in Rectal Diseases with a site in United States — 4 open to participants now, 7 under way, 3 of them phase 3. Rectal Diseases · United States.
Among the 33 studies in Rectal Diseases with a site in United States, this one is the 14th largest by enrollment of the 22 interventional ones, is one of 2 that started in 2019, is one of 7 with no phase, and was the 24th registered.
87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.
This study's enrollment of 60 is below the median of 114 across 59 interventional studies indexed under Rectal Diseases.
Browse Rectal Diseases studies →4 of the 33 studies in Rectal Diseases with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 8 Rectal Diseases studies recruiting now, 6 (75%) set no upper age limit and 1 (13%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2019.
Median enrollment 106 across the 22 interventional studies, 435 across the 11 observational. Of the 25 that completed or were terminated, 12 (48%) have results posted.
18 of 33 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 1 study filed under Rectal Diseases — fewer than ten, so there is no comparison to draw.
3 of the studies in Rectal Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05776277Phase 3Cook MyoSiteIltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury | 2026-12 |
| NCT07351071Medtronic - MITGPost-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections | 2027-04-30 |
| NCT07776353Kaiser PermanenteUnderstanding New Cachexia Subtypes Through Observational Epidemiological Research | 2027-05 |
Among the 33 studies in Rectal Diseases with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
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.
Rate of Opioid Use
Postoperative opioid use will be measured in morphine milligram equivalents per day (MME)
Time frame: Up to 30 days post surgery
Pain Score on the Visual Analog Scale (VAS)
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.
Time frame: Up to 30 days post surgery
Pain Score on the Functional Pain Scale (FPS)
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.
Time frame: Up to 30 days post surgery
Score on the EQ-5D-3L
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.
Time frame: Up to 30 days post surgery
Plan to share: No
Ran from Jun 2019 to primary completion in May 2020, 11 months.
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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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