C20
Conditions
Interventions
Group 1: Early stoma closure (experimental group): 8-10 days after tumor resection (LAR) followed by chemotherapy
Group 2: Late stoma closure (control group): 25 weeks after randomisation and after re
Sponsors
Chirurgische Klinik, Universitätsklinikum Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Quality of life: QoL baseline will be measured (EORTC QLQ-C30 and the CR 29, in German) at randomisation (baseline), before starting chemotherapy and 12 and 18 weeks after the start of chemotherapy. During the course of the trial, QoL will be determined 7 and 24 months after randomisation; b) rate of stoma related complications: percentage of patients developing stoma related complications over a period of 28 weeks after randomisation in relation to all patients; c) number of re-operations: the number of additional operations performed because of complications related to the stoma itself or the stoma closure procedure; d) individual CoC rate: the proportion of completed chemotherapy cycles calculated for each patient in relation to the planned number of cycles determined 7 months after randomisation; e) dose modification or delay: measured 7 months after randomisation, the proportion of randomised patients receiving a dose modification or delay in relation to the total number of patients receiving adjuvant chemotherapy; f) disease-free survival: determined from the date of randomisation to the date of diagnosis of recurrence or death during the 24 months follow-up period; g) local recurrence-free survival and distant recurrence-free survival: determined from the date of randomisation to the date of the respective recurrence event or death during the 24 months follow-up period; h) rate of symptomatic rectal anastomotic leaks: proportion of anastomotic leakages clinically symptomatic in relation to the total number of stoma closures within 30 days after the procedure; i) cumulative days of hospitalisation: additional days in hospital in both groups over a period of 28 weeks after randomisation; j) cumulative readmissions: number of readmissions due to complications related to the stoma closure operation or stoma related complications over a period of 28 weeks after randomisation. | — |
Countries
Germany
Contacts
Public ContactFlavius Sandra-Petrescu und Herr Dr. Florian Herrle
Chirurgische Klinik, Universitätsklinikum Mannheim
Outcome results
None listed