Anorectal DisorderPhase 4NCT03738904
Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
A Phase 4 study testing ERAS in people with Anorectal Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorectal Disorder
- What is being tested?
- ERAS
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2018to 18 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Anorectal Disorder
- Being tested
- ERAS, Standard of care
- Medical subject headings
- Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASCombination product
Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol
Standard of careCombination product
Oxcodone PO Ketorolac IV only (intraop)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (multimodal ERAS) | Experimental | 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 Receives: Combination Product: ERAS |
| Arm 2 (control) | Active comparator | 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 Receives: Combination Product: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Narcotic Use Postoperatively in Oral Morphine Equivalents
Total amount of narcotics used
Measured: 1 week postoperatively
Secondary outcomes (2)
Median Postoperative Pain Scores
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
Measured: 1 week postoperatively
Complications
Number of participants who experienced complications
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start26 Oct 2018
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorectal DisorderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Zaghiyan, Cedars-Sinai Medical Center
- Investigators
- Karen Zaghiyan, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738904
- Sponsor's protocol ID
- Pro00054080
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2018
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17.
PubMed 39016381
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
- ClinicalTrials.gov ID
- NCT03738904
- Acronym / sponsor ID
- Pro00054080
- Conditions
- Anorectal Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (multimodal ERAS) | Experimental | Combination Product: ERASArm1 (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 |
| Arm 2 (control) | Active comparator | Combination Product: Standard of carePostoperative 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASGabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol | Combination product | Arm 1 (multimodal ERAS) |
| Standard of careOxcodone PO Ketorolac IV only (intraop) | Combination product | Arm 2 (control) |
Primary outcome
Total Narcotic Use Postoperatively in Oral Morphine Equivalents
Time frame: 1 week postoperatively
Total amount of narcotics used
2 secondary outcomes
Median Postoperative Pain Scores
Time frame: 1 week postoperatively
Complications
Time frame: 1 month postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39016381Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17.
- Individual participant dataSharing planned: No
Related trials for Anorectal Disorder
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Not yet recruiting
Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children
Bowel Dysfunction, Dysmotility
Not yet recruitingPhase 2
Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum.
Lymphogranuloma Venereum, no Anorectal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Zaghiyan, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ERAS in people with Anorectal Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Narcotic Use Postoperatively in Oral Morphine Equivalents (time frame: 1 week postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.