Phase 4
N=109
Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
Anorectal Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03738904 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Total Narcotic Use Postoperatively in Oral Morphine Equivalents — 8; 79 Oral morphine miligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ERAS (Combination_product); Standard of care (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Narcotic Use Postoperatively in Oral Morphine Equivalents |
8; 79 | — |
| SECONDARY Median Postoperative Pain Scores |
4; 6 | — |
| SECONDARY Complications |
4; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03738904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.