Trial Outcomes & Findings for Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery (NCT NCT03738904)

Results Overview

Total amount of narcotics used

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

111 participants

Primary outcome timeframe

1 week postoperatively

Results posted on

2023-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Multimodal ERAS) Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)
Overall Study STARTED	54	55
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Multimodal ERAS) n=45 Participants Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) n=44 Participants Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=89 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=45 Participants	44 Participants n=44 Participants	88 Participants n=89 Participants
Age, Categorical >=65 years	1 Participants n=45 Participants	0 Participants n=44 Participants	1 Participants n=89 Participants
Age, Continuous	38 years n=45 Participants	38 years n=44 Participants	38 years n=89 Participants
Sex: Female, Male Female	25 Participants n=45 Participants	16 Participants n=44 Participants	41 Participants n=89 Participants
Sex: Female, Male Male	20 Participants n=45 Participants	28 Participants n=44 Participants	48 Participants n=89 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	45 participants n=45 Participants	44 participants n=44 Participants	89 participants n=89 Participants

PRIMARY outcome

Timeframe: 1 week postoperatively

Total amount of narcotics used

Outcome measures

Outcome measures
Measure	Arm 1 (Multimodal ERAS) n=45 Participants Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) n=44 Participants Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)
Total Narcotic Use Postoperatively in Oral Morphine Equivalents	8 Oral morphine miligram equivalents Interval 0.0 to 390.0	79 Oral morphine miligram equivalents Interval 0.0 to 600.0

SECONDARY outcome

Timeframe: 1 week postoperatively

Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant

Outcome measures

Outcome measures
Measure	Arm 1 (Multimodal ERAS) n=45 Participants Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) n=44 Participants Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)
Median Postoperative Pain Scores	4 score on a scale Interval 0.0 to 10.0	6 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 1 month postoperatively

Number of participants who experienced complications

Outcome measures

Outcome measures
Measure	Arm 1 (Multimodal ERAS) n=45 Participants Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) n=44 Participants Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)
Complications	4 Participants	2 Participants

Adverse Events

Arm 1 (Multimodal ERAS)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 2 (Control)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1 (Multimodal ERAS) n=45 participants at risk Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control: 1. Gabapentin oral 300 mg TID (#42, refill #1) 2. Acetaminophen oral 1000mg TID (#42, refill #1) 3. Ketorolac oral 10 mg TID (#15, refill #0) 4. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) Postoperative laxative regimen: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. Daily milk of magnesia 1 tablespoon if no bowel movement by POD2 until regular bowel movements 3. Daily mineral oil 1 table spoon if no bowel movement by POD2 until regular bowel movements ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol	Arm 2 (Control) n=44 participants at risk Postoperative pain control: 1. Oxycodone oral 5 mg PRN every 6 hours (#30, refill #0) 2. 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: 1. Daily MiraLAX 1 scoop in 1 glass of water for 15 days 2. 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 Standard of care: Oxcodone PO Ketorolac IV only (intraop)
Surgical and medical procedures Adverse event not resulting in significant morbidity or mortality	8.9% 4/45 • 30 days postoperatively Any unexpected or adverse event that may or may not have resulted in unplanned visit to the emergency department, clinic, or additional tests or procedures.	4.5% 2/44 • 30 days postoperatively Any unexpected or adverse event that may or may not have resulted in unplanned visit to the emergency department, clinic, or additional tests or procedures.

Additional Information

Dr. Karen Zaghiyan

Cedars-Sinai Medical Center

Phone: 310-289-9224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place