NCT03738904

Brief Summary

The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

November 8, 2018

Results QC Date

September 4, 2023

Last Update Submit

November 30, 2023

Conditions

Anorectal Disorder

Outcome Measures

Primary Outcomes (1)

  • Total Narcotic Use Postoperatively in Oral Morphine Equivalents

    Total amount of narcotics used

    1 week postoperatively

Secondary Outcomes (2)

  • Median Postoperative Pain Scores

    1 week postoperatively

  • Complications

    1 month postoperatively

Study Arms (2)

Arm 1 (multimodal ERAS)

EXPERIMENTAL

Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements

Combination Product: ERAS

Arm 2 (control)

ACTIVE COMPARATOR

Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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

Combination Product: Standard of care

Interventions

ERASCOMBINATION_PRODUCT

Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol

Arm 1 (multimodal ERAS)
Standard of careCOMBINATION_PRODUCT

Oxcodone PO Ketorolac IV only (intraop)

Arm 2 (control)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
  • Males or females, age 18 to 70 years old at the time of study screening;
  • American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective anorectal surgery
  • Patients undergoing the following hemorrhoid surgeries will be included:
  • Excisional single column or multiple column hemorrhoidectomy including internal and external component
  • Stapled hemorrhoidpexy (aka procedure for prolapsed hemorrhoids with or without excision of external hemorrhoid or skin tag)
  • Trans anal hemorrhoidal dearterialization with mucopexy (THD) with or without excision of external hemorrhoid or skin tag
  • Patients undergoing the following anal fistula surgery will be included:
  • Anal fistulotomy or fistulectomy of intersphincteric or tran-sphincteric fistula with wound \> 1 cm
  • Endorectal or an cutaneous advancement flap for anal fistula re-pair

You may not qualify if:

  • Unable or unwilling to provide informed consent or comply with study procedures
  • American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries
  • Children \<18
  • Patients over age 70 due to small risk of altered mental status with gabapentin in elderly6
  • Patients with impaired renal clearance (baseline creatinine 1.5mg/dL, creatinine clearance \< 60ml/min or known renal dysfunction)
  • Patients with known liver dysfunction (Childs class A, B, or C)
  • Patients with prior liver or kidney transplant
  • Pregnant patients
  • Patients requiring emergency surgery
  • Patients taking narcotics or steroids at the time of surgery
  • Patients having external hemorrhoidectomy or skin anal tag excision only
  • Patients having anal abscess drainage, seton placement without definitive fistula repair, or ligation of intersphincteric fistula tract, subcutaneous fistulotomy or fistulotomy with wound \<1 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Related Publications (1)

  • Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17.

    PMID: 39016381DERIVED

MeSH Terms

Conditions

Rectal Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Karen Zaghiyan
Organization
Cedars-Sinai Medical Center
karen.zaghiyan@cshs.org
310-289-9224

Study Officials

  • Karen Zaghiyan, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

October 26, 2018

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

December 18, 2023

Results First Posted

December 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)