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



Status:Recruiting
Healthy:No
Age Range:18 - 70
Updated:11/14/2018
Start Date:October 26, 2018
End Date:May 31, 2019
Contact:Gayane Ovsepyan, MPH
Email:gayane.ovsepyan@cshs.org
Phone:310-289-9224

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

- 1. Able to freely give written informed consent to participate in the study and have
signed the Informed Consent Form; 2. Males or females, age 18 to 70 years old at the
time of study screening; 3. American Society of Anesthesiologists (ASA) Class I-III
(Appendix III) undergoing elective anorectal surgery 4. Patients undergoing the
following hemorrhoid surgeries will be included:

1. Excisional single column or multiple column hemorrhoidectomy including internal
and external component

2. Stapled hemorrhoidpexy (aka procedure for prolapsed hemor-rhoids with or without
excision of external hemorrhoid or skin tag)

3. Trans anal hemorrhoidal dearterialization with mucopexy (THD) with or without
excision of external hemorrhoid or skin tag 5. Patients undergoing the following
anal fistula surgery will be included:

1. Anal fistulotomy or fistulectomy of intersphincteric or tran-sphincteric fistula
with wound > 1 cm

2. Endorectal or anocutaneous advancement flap for anal fistula re-pair

Exclusion Criteria:

- 1. Unable or unwilling to provide informed consent or comply with study procedures 2.
American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries 3.
Children <18 4. Patients over age 70 due to small risk of altered mental status with
gabapentin in elderly6 5. Patients with impaired renal clearance (baseline creatinine
1.5mg/dL, creatinine clearance < 60ml/min or known renal dysfunction) 6. Patients with
known liver dysfunction (Childs class A, B, or C) 7. Patients with prior liver or
kidney transplant 4. Pregnant patients 5.Patients requiring emergency surgery 6.
Patients taking narcotics or steroids at the time of surgery 7. Patients having
external hemorrhoidectomy or skin anal tag excision only 8. 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
We found this trial at
1
site
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials