Clinical trial NCT02944188: Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer
Official title: Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: enhanced recovery after surgery
right hemicolectomy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of postoperative complications
timeFrame: 30 days from surgery
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: disease-free survival
timeFrame: 3 years
measure: operative mortality
timeFrame: 30 days post operatively
Other outcomes:
measure: operative time
timeFrame: Day 1
measure: estimated blood loss
timeFrame: Day 1
measure: number of retrieved lymph nodes
timeFrame: 1 week post operatively
measure: postoperative hospital stay
timeFrame: 30 days post operatively
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Hong Jiang, MD
role: STUDY_DIRECTOR
References: