Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03738904
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03738904
Study Brief:
Protocol Section:
NCT03738904