Colorectal NeoplasmsEarly Phase 1NCT03042091
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
A Early Phase 1 study testing Polyethylene Glycol, Neomycin and Metronidazole Hydrochloride in people with Colorectal Neoplasms and Diverticulitis, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases
- What is being tested?
- Polyethylene Glycol, Neomycin and Metronidazole Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing ileocolic resections, partial and total colectomies, and rectal resections for neoplasm, inflammatory bowel disease, or diverticulitis
- Subjects with the mental capacity to give informed consent
Who cannot join
- Patients undergoing emergent colorectal resections
- Patients who are decisionally-impaired and lack the mental capacity to give informed consent
Trial locations and contacts
1 site in 1 country.
Benjamin Phillips, MD contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Benjamin Phillips, MD, 215-551-0360
About this study
Official title: Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the difference in rates of surgical site infection following elective colorectal resections in patients given a preoperative mechanical bowel prep with oral antibiotics as compared to preoperative oral antibiotics alone.
SECONDARY OBJECTIVES:
- To determine rates of post-operative clostridium difficile infection, adynamic ileus, cardiopulmonary complications, urinary tract infection, length of stay and mortality in patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative antibiotics alone.
- Conditions
- Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Site Infection
- Being tested
- Polyethylene Glycol, Neomycin, Metronidazole Hydrochloride, Therapeutic Conventional Surgery
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolDrug
Also called 25322-68-3, 57859, Ethanol, Glycol
Given orally
NeomycinDrug
Also called 1404-04-2, Neomycin Complex
Given orally
Metronidazole HydrochlorideDrug
Also called 69198-10-3, Flagyl, Metro I.V., Satric
Given orally
Therapeutic Conventional SurgeryProcedure or surgery
Undergo colorectal resection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (mechanical bowel prep, oral antibiotics) | Active comparator | Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. Receives: Drug: Polyethylene Glycol; Drug: Neomycin; Drug: Metronidazole Hydrochloride; Procedure: Therapeutic Conventional Surgery |
| Arm II (oral antibiotics) | Experimental | Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. Receives: Drug: Neomycin; Drug: Metronidazole Hydrochloride; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
The difference in incidence of SSI (antibiotics [ABX] - ABX + prep) will be calculated with an upper 95% confidence bound. Exploratory analysis will consider stratum specific estimates of differences in subgroups defined by BMI and diabetes status.
Measured: Up to 30 days post operation
Secondary outcomes (6)
Incidence of post-operative clostridium difficile infection
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Measured: Up to 30 days post operation
Incidence of adynamic ileus
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.
Measured: Up to 30 days post operation
Incidence of cardiopulmonary complications
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Measured: Up to 30 days post operation
Incidence of urinary tract infection
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Measured: Up to 30 days post operation
Length of hospital stay
Measured: Up to 30 days post operation
Incidence of mortality
Measured: Up to 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startSep 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Phillips, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042091
- Sponsor's protocol ID
- 16D.204
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
PubMed 36748942
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
- ClinicalTrials.gov ID
- NCT03042091
- Acronym / sponsor ID
- 16D.204
- Conditions
- Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Site Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the difference in rates of surgical site infection following elective colorectal resections in patients given a preoperative mechanical bowel prep with oral antibiotics as compared to preoperative oral antibiotics alone.
SECONDARY OBJECTIVES:
- To determine rates of post-operative clostridium difficile infection, adynamic ileus, cardiopulmonary complications, urinary tract infection, length of stay and mortality in patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative antibiotics alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (mechanical bowel prep, oral antibiotics) | Active comparator | Drug: Polyethylene Glycol, Drug: Neomycin, Drug: Metronidazole Hydrochloride, Procedure: Therapeutic Conventional SurgeryPatients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. |
| Arm II (oral antibiotics) | Experimental | Drug: Neomycin, Drug: Metronidazole Hydrochloride, Procedure: Therapeutic Conventional SurgeryPatients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing ileocolic resections, partial and total colectomies, and rectal resections for neoplasm, inflammatory bowel disease, or diverticulitis
- Subjects with the mental capacity to give informed consent
Key exclusion criteria (2 listed)
- Patients undergoing emergent colorectal resections
- Patients who are decisionally-impaired and lack the mental capacity to give informed consent
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 |
|---|---|---|
| Polyethylene GlycolAlso: 25322-68-3, 57859, Ethanol, GlycolGiven orally | Drug | Arm I (mechanical bowel prep, oral antibiotics) |
| NeomycinAlso: 1404-04-2, Neomycin ComplexGiven orally | Drug | Arm I (mechanical bowel prep, oral antibiotics), Arm II (oral antibiotics) |
| Metronidazole HydrochlorideAlso: 69198-10-3, Flagyl, Metro I.V., SatricGiven orally | Drug | Arm I (mechanical bowel prep, oral antibiotics), Arm II (oral antibiotics) |
| Therapeutic Conventional SurgeryUndergo colorectal resection | Procedure or surgery | Arm I (mechanical bowel prep, oral antibiotics), Arm II (oral antibiotics) |
Primary outcome
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
Time frame: Up to 30 days post operation
The difference in incidence of SSI (antibiotics [ABX] - ABX + prep) will be calculated with an upper 95% confidence bound. Exploratory analysis will consider stratum specific estimates of differences in subgroups defined by BMI and diabetes status.
6 secondary outcomes
Incidence of post-operative clostridium difficile infection
Time frame: Up to 30 days post operation
Incidence of adynamic ileus
Time frame: Up to 30 days post operation
Incidence of cardiopulmonary complications
Time frame: Up to 30 days post operation
Incidence of urinary tract infection
Time frame: Up to 30 days post operation
Length of hospital stay
Time frame: Up to 30 days post operation
Incidence of mortality
Time frame: Up to 30 days post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 36748942Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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.
Benjamin Phillips, MD contact
Benjamin Phillips, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Polyethylene Glycol, Neomycin and Metronidazole Hydrochloride in people with Colorectal Neoplasms and Diverticulitis, run by Thomas Jefferson University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Phillips, MD ((215) 551-0360), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (time frame: Up to 30 days post operation). 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 NCT03042091, 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 22 Aug 2018.