NCT03042091

Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery

Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Diverticulitis
• Inflammatory Bowel Diseases
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Polyethylene Glycol	Given orally
DRUG	Neomycin	Given orally
DRUG	Metronidazole Hydrochloride	Given orally
PROCEDURE	Therapeutic Conventional Surgery	Undergo colorectal resection

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2017-02-03
• Last updated: 2018-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study