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A Randomized Controlled Study of Prophylactic Stoma in Unresected Peritoneal Metastasis of Colorectal Cancer

A Randomized Controlled Study of Prophylactic Stoma in Unresected Peritoneal Metastasis of Colorectal Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064016
Enrollment
Unknown
Registered
2022-09-23
Start date
2022-09-29
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Colorectal cancer

Interventions

experimental arm:stoma
control arm:no stoma

Sponsors

The Sixth Affiliated Hospital of Sun Yat-San University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-80 years old; 2.Pathological diagnosis of colorectal cancer complited with pertioneal metastasis,except from appendix; 3.The primary or peritoneal metastasis cannot be surgically resected,and the evaluation criteria should meet one of the following:(1)PCI score 20 points(intraoerative score or preperative imaging score);(2)Poor general condition,unable to tolerate tumor resection;(3)Inteninal perforation cannot tolerate major sugery; 4.ECOG body show prostective:strength 0 to 2 points; 5.Important viscera function is engough, that can tolerate colostomy suigery and anesthesia risk; 6.Sign informed consent

Exclusion criteria

Exclusion criteria: 1.Complete intestinal obstruction diagnosed by examination or clinical diagnosis; 2.Intestinal perforation with severe infection; 3.It has been included in other clinical trials

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
The incidence and reminission rate of intestinal obstruction at 1,3,6 months after operation;EORTC CLC 30 quality of life score, MSKCC intestinal symptom score;Incindence of chemmotherapy toxicity and side;Incindence of intestinal perforation;

Countries

China

Contacts

Public ContactHui Wang

The Sixth Affiliated Hospital of Sun Yat-Sen University

wang89@mail.sysu.edu.cn13926424886

Outcome results

None listed

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