Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery (NCT03738904) | Clinical Trial Compass
CompletedPhase 4
Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
United States111 participantsStarted 2018-10-26
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Narcotic Use Postoperatively in Oral Morphine Equivalents