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ERAS for Anorectal Disorders

Phase 4

Waitlist Available

Led By Karen Zaghiyan, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month postoperatively

Awards & highlights

Study Summary

This trial is testing whether a more aggressive post-operative pain regimen that targets multiple pain pathways can reduce post-operative pain, constipation, and dependence on opioids.

Eligible Conditions

Anorectal Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total Narcotic Use Postoperatively in Oral Morphine Equivalents

Secondary outcome measures

Complications

Median Postoperative Pain Scores

Side effects data

From 2022 Phase 4 trial • 111 Patients • NCT03738904

Adverse event not resulting in significant morbidity or mortality

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Multimodal ERAS)

Arm 2 (Control)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (multimodal ERAS)Experimental Treatment1 Intervention

Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: Gabapentin oral 300 mg TID (#42, refill #1) Acetaminophen oral 1000mg TID (#42, refill #1) Ketorolac oral 10 mg TID (#15, refill #0) Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: Daily MiraLAX 1 scoop in 1 glass of water for 15 days Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements

Group II: Arm 2 (control)Active Control1 Intervention

Postoperative pain control: Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Patients will be allowed to take oral acetaminophen and ibuprofen over the counter if needed but active narcotic-sparing pain management regimen will not be implemented Postoperative laxative regimen: Daily MiraLAX 1 scoop in 1 glass of water for 15 days Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements Daily mineral oil 1 table spoon if no bowel movement by POD2 until regu-lar bowel movements

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ERAS

2018

Completed Phase 4

~2150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,746 Total Patients Enrolled

Karen Zaghiyan, MDPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center, Karen Zaghiyan, Md

5 Previous Clinical Trials

454 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in the scope of this research endeavour?

"Affirmative. According to clinicaltrials.gov, this research study is presently looking for volunteers having been initially posted on October 26th 2018 and most recently edited on October 23rd 2021. The trial necessitates 88 individuals from a single point of enrollment."

Answered by AI

Does the research team accept individuals of a certain age for inclusion in this experiment?

"All potential candidates for this trial must be aged 18 years or older but no more than 70."

Answered by AI

To what demographic is enrollment in this trial open?

"For this research, 88 participants aged 18-70 with anorectal disorders are eligible to apply. In addition, they must have had excisional single or multiple column hemorrhoidectomy including internal and external components in order to be included. Gender is irrelevant for qualification."

Answered by AI

Has the FDA sanctioned Enhanced Recovery After Surgery (ERAS)?

"The safety of ERAS is judged to be a 3 out of 3, as this phase 4 trial indicates that the medication has been approved by relevant authorities."

Answered by AI

Is there space available for participants in this experiment?

"Per the information hosted on clinicaltrials.gov, this research study is currently recruiting suitable candidates. This trial was first made available to participants in October 26th 2018 and has recently been updated as of October 23rd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery

Karen Zaghiyan 2018. "Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03738904.