Clinical trial NCT03042091: Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
Official title: Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Colorectal Neoplasms
Diverticulitis
Inflammatory Bowel Diseases
Surgical Site Infection
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 224
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients undergoing emergent colorectal resections
* Patients who are decisionally-impaired and lack the mental capacity to give informed consent

Primary outcomes:
measure: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
timeFrame: Up to 30 days post operation
Secondary outcomes:
measure: Incidence of post-operative clostridium difficile infection
timeFrame: Up to 30 days post operation
measure: Incidence of adynamic ileus
timeFrame: Up to 30 days post operation
measure: Incidence of cardiopulmonary complications
timeFrame: Up to 30 days post operation
measure: Incidence of urinary tract infection
timeFrame: Up to 30 days post operation
measure: Length of hospital stay
timeFrame: Up to 30 days post operation
measure: Incidence of mortality
timeFrame: Up to 30 days post operation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Benjamin Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: