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

Primary Purpose

Anorectal Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

ERAS

Standard of care

About this trial

This is an interventional treatment trial for Anorectal Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cedars Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (multimodal ERAS)

Arm 2 (control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total narcotic use postoperatively in oral morphine equivalents

Total amount of narcotics used

Secondary Outcome Measures

Mean postoperative pain scores

t Total amount of pain

Complications

Any complications experienced

Full Information

NCT ID

NCT03738904

First Posted

November 8, 2018

Last Updated

January 6, 2023

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03738904

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 26, 2018 (Actual)

Primary Completion Date

August 18, 2022 (Actual)

Study Completion Date

August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Although pain is a predictable part of the postoperative experience, inadequate management of pain is common and can have profound implications Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. Mostly, pain is treated with opioids which are narcotics. medically they are primarily used for pain relief and these are historically considered "safe" drugs as they do not impose an increased risk of bleeding, kidney, or stomach problems. However, many patients taking high dose opioids have a higher risk of constipation. Unrelieved postoperative pain may result in economic and medical implications such as extended lengths of stay, readmissions, and patient dissatisfaction with medical care. With the rising concern over narcotic use, physicians are increasingly seeking alternative ways to help patients manage pain throughout their hospital stay and beyond However, few studies in anorectal surgery have shown that using an aggressive postoperative non-narcotic pain regimen (ERAS) can help reduce postoperative pain and decreased returns to emergency care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorectal Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (multimodal ERAS)

Arm Type

Experimental

Arm Description

Arm Title

Arm 2 (control)

Arm Type

Active Comparator

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

ERAS

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

Standard of care

Intervention Description

Oxcodone PO Ketorolac IV only (intraop)

Primary Outcome Measure Information:

Title

Total narcotic use postoperatively in oral morphine equivalents

Description

Total amount of narcotics used

Time Frame

1 week postoperatively

Secondary Outcome Measure Information:

Title

Mean postoperative pain scores

Description

t Total amount of pain

Time Frame

1 week postoperatively

Title

Complications

Description

Any complications experienced

Time Frame

1 month postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Zaghiyan, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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