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Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study

Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study - Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043162
Enrollment
108
Registered
2021-01-28
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

left colon cancer, rectal cancer

Interventions

mOAMBP group(sodium picosulfate hydrate + Kanamycin, Metronidazole) (combined drug) Kanamycin 250mg 12C x3(after lunch, dinner, and before bedtime) and Metronidazole 250mg 6C x3(after lunch, dinne

Sponsors

Tokyo Medical and Dental University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing resection for rectal cancer or left-sided colon cancer, with or without diverting ileostomy 2) Patients undergoing DST or transanal bowel anastomosis 3) Patients between 20 and 85 years old 4) Patients with a performance status (ECOG) of 0 or 1 5) Patients who meet the following criteria for laboratory tests within 30 days of enrollment 1. White blood cell: WBC = 3000, or 3000<WBC<10000/ul 2. Neutrophils: Neu = 1500, Neu > 1500/ul 3. Hemoglobin: Hb = 9.0 or > 9.0g/dl 4. Platelet: Plt = 70000 or > 70000/ul 5. Total Bilirubin: T.Bil = 1.5 or < 1.5mg/dl 6. AST: AST = 100 or < 100IU/l 7. ALT: ALT = 100 or < 100IU/l 8. Albumin: Alb = 2.5 or > 2.5g/dl 6) Patients who have given informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who need emergency surgery 2) Patients with preoperative intestinal obstruction 3) Patients with suspected active bacterial infection (abscess formation, colon cancer perforation, etc.) 4) Patients who are pregnant or have the potential to become pregnant 5) Diabetic patients with poor control (HbA1c 8.0 or < 8.0) 6) Patients who are allergic to drugs used in the study (macrogol, sodium picosulfate hydrate, kanamycin, metronidazole) 7) Patients undergoing neoadjuvant radiotherapy or neoadjuvant chemotherapy 8) Patients with colostomy or ileostomy 9) Patients who have not given informed consent 10) Patients who are judged by the principal investigator or the investigator to be ineligible for the safe conduct of this study

Design outcomes

Primary

MeasureTime frame
Incidence of SSI

Secondary

MeasureTime frame
Incidence of postoperative complications excluded SSI, operation time, extent of bleeding, postoperative hospital stay, intraoperative adverse events, degree of patient burden, degree of intraoperative intestinal dilation

Countries

Japan

Contacts

Public ContactSodai Arai

Tokyo Medical and Dental University Graduate School of Medicine Department of Gastrointestinal Surgery

sarai.srg1@tmd.ac.jp03-5803-5254

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026