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A Randomized Controlled Trial of Saline to Improve Diversion Colitis

A Randomized Controlled Trial of Saline to Improve Diversion Colitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040655
Enrollment
Unknown
Registered
2020-12-06
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Diversion Colitis

Interventions

glucose saline intervention group:0.9% sodium chloride injection
blank control group:none

Sponsors

First Affiliated Hospital, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Prophylactic ileal stoma after middle and low rectal cancer surgery; 2. Aged 18 to 80 years old.

Exclusion criteria

Exclusion criteria: 1. Patients who withdrew midway (including loss to follow-up and non-response); 2. Patients who had IBD (Crohn's disease and ulcerative colitis), radiation enteritis and other intestinal inflammatory diseases that affected the results of observation before treatment; 3. Existence of anastomotic leakage; 4. Patients with moderate to severe renal impairment or with severe heart and lung diseases and severe immunodeficiency; 5. Received immunosuppression or antibiotic therapy four weeks before enrollment; 6. Other patients deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Intestinal inflammation score under colonoscopy>=2;

Secondary

MeasureTime frame
Intestinal Mucosal Pathology Score;Composition of intestinal flora and its metabolites;Nutritional status;Immune status;

Countries

China

Contacts

Public ContactGuosheng Wu

First Affiliated Hospital, Zhejiang University

guosheng_wu@zju.edu.cn+86 17857310313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026