Randomised trial comparing completeness of adjuvant chemotherapy after earlyvs. late diverting stoma closure in low anterior resection for rectal cancer

Not Applicable

• Conditions: C20; Malignant neoplasm of rectum

• Registration Number: DRKS00005113
• Lead Sponsor: Chirurgische Klinik, Universitätsklinikum Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-28
• Study Completion: 2024-02-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

a) temporary diverting stoma (independent from the stoma type);
b) curative resection;
c) elective LAR with TME (laparoscopic, open or converted) for UICC II – III rectal cancer;
d) no anastomotic leakage (endoscopic or contrast enema assessment of the anastomosis around day 7 after LAR);
e) indication to undergo adjuvant chemotherapy;
f) female or male with an age =18 years;
g) written informed consent;
h) patient is able to cooperate.

Exclusion Criteria

a) immunocompromised patients (HIV positive, patients under chemotherapy or under immunosuppressive therapy, e.g. prednisolone >= 10 mg);
b) ASA > 3;
c) inflammatory bowel disease;
d) contraindication to adjuvant chemotherapy arising after rectal cancer resection;
e) participation in another intervention-trial with interference of intervention and outcome of this study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completness of Chemotherapy [CoC = the proportion of the randomised patients which complete all planned cycles of adjuvant chemotherapy (4 Cy. 5-FU or 5-FU plus folinic acid, or 5 Cy. Capecitabine or 5 Zy. XELOX or 8 Zy. de Gramont regimen or 8 Zy. FOLFOX6)] measured at 28 weeks after randomisation. Additional administration of folic acid is allowed.