Colon Cancer
Conditions
Keywords
enhanced recovery after surgery, right hemicolectomy
Brief summary
In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.
Detailed description
This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinoma；(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded. All particapants were recruited and randomly assigned to receive laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
Interventions
PROCEDURELaparoscopic right hemicolectomy plus ERAS
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
PROCEDUREOpen right hemicolectomy plus ERAS
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Sponsors
Xu jianmin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years; 2. Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma; 3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system) 4. Performance status (ECOG) 0\ 1 5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization) 6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization); 7. Written informed consent for participation in the trial.
Exclusion criteria
1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix 2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding 3. Known drug abuse/ alcohol abuse 4. Legal incapacity or limited legal capacity 5. Pre-existing peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative complications | 30 days from surgery | The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | Time from randomization to deaths resulting from any reason |
| disease-free survival | 3 years | Time from randomization to recurrence at any site or deaths resulting from any reason |
| operative mortality | 30 days post operatively | Deaths related to surgery within 30 days from surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| operative time | Day 1 | Time from start of incision to finish of abdomial closure |
| estimated blood loss | Day 1 | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. |
| number of retrieved lymph nodes | 1 week post operatively | Numbers according to the pathological report |
| postoperative hospital stay | 30 days post operatively | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge. |
Countries
China
Outcome results
None listed