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A prospective, multicenter, randomized controlled study of the association between preoperative oral antibiotics and postoperative anastomotic leakage after colorectal surgery

A prospective, multicenter, randomized controlled study of the association between preoperative oral antibiotics and postoperative anastomotic leakage after colorectal surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035550
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-08-30
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative anastomotic leakage

Interventions

trial group:Antibiotics were used one day before operation
control group:no antibiotics were used before operation

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have been diagnosed with colorectal tumors or other patients who need elective colorectal surgery (including partial and total resection, with conventional laparotomy and two- or three-hole laparoscopic surgery) and have no obvious contraindications to surgery, and the patients and their families voluntarily participate in the clinical trial and sign the relevant informed consent after the informed consent conversation of the clinical trial.

Exclusion criteria

Exclusion criteria: (1) Patients who took various antibiotics by themselves or under the doctor's advice within 2 weeks before surgery; (2) Patients with previous or current diagnosis of inflammatory bowel disease; (3) Patients diagnosed with acute intestinal perforation or acute small intestinal diverticulum; (4) Patients with ischemic colitis or infectious colitis were included in the diagnosis; (5) Patients who need two or more operations at the same time; (6) Patients who have been diagnosed with acute or chronic peritonitis or other infectious diseases and need anti-infective treatment in the perioperative period; (7) Any acute physiological disorder indicates that the patient needs emergency surgery and cannot undergo elective surgery [such as the need for preoperative mechanical ventilation, preoperative acute renal failure, preoperative systemic inflammatory release syndrome, sepsis or septic shock]; (8) ASA rating is 5; (9) Patients with immunodeficiency, immunosuppression or autoimmune diseases (such as patients undergoing allogeneic bone marrow transplantation within the past five years, taking immunosuppressive drugs, SLE, etc.). (10) Patients refused to sign informed consent to participate in the trial. (11) Other circumstances in which the patient is unable to cooperate with the doctor normally due to personal reasons or in which the investigator considers it unsuitable to participate in the experiment. (12) All single-port laparoscopic procedures, natural-port procedures, and various new surgical procedures are required.

Design outcomes

Primary

MeasureTime frame
Incidence of anastomotic leakage;Postoperative infection rate;Inflammatory indicators;

Secondary

MeasureTime frame
30-day readmission rate;Incision healing;

Countries

China

Contacts

Public ContactJi Gang

The First Affiliated Hospital of Air Force Military Medical University

jigang@fmmu.edu.cn+86 13572152581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026