Colon CancerNCT02944188
Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer
A study testing Laparoscopic right hemicolectomy plus ERAS and Open right hemicolectomy plus ERAS in people with Colon Cancer, run by Xu jianmin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Laparoscopic right hemicolectomy plus ERAS and Open right hemicolectomy plus ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2014to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years;
- Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
- 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)
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- 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);
- Written informed consent for participation in the trial.
Who cannot join
- 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
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Laparoscopic right hemicolectomy plus ERAS, Open right hemicolectomy plus ERAS
- Keywords
- enhanced recovery after surgery, right hemicolectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right hemicolectomy plus ERASProcedure or surgery
Also called LRH ERAS
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Open right hemicolectomy plus ERASProcedure or surgery
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
| Study group | Role | What they receive |
|---|---|---|
| LRH plus ERAS | Experimental | patients undergo Laparoscopic right hemicolectomy plus ERAS Receives: Procedure: Laparoscopic right hemicolectomy plus ERAS |
| ORH plus ERAS | Active comparator | patients undergo open right hemicolectomy plus ERAS Receives: Procedure: Open right hemicolectomy plus ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative complications
The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification
Measured: 30 days from surgery
Secondary outcomes (3)
overall survival
Time from randomization to deaths resulting from any reason
Measured: 3 years
disease-free survival
Time from randomization to recurrence at any site or deaths resulting from any reason
Measured: 3 years
operative mortality
Deaths related to surgery within 30 days from surgery
Measured: 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study start1 Dec 2014
- Primary completion30 Dec 2017
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu jianmin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu jianmin, Fudan University
- Investigators
- Hong Jiang, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944188
- Sponsor's protocol ID
- ERAS-02
- Other IDs
- 82345432
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2015
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol
- ClinicalTrials.gov ID
- NCT02944188
- Acronym / sponsor ID
- ERAS-02
- Conditions
- Colon Cancer
- Keywords
- enhanced recovery after surgery, right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Xu jianminUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRH plus ERAS | Experimental | Procedure: Laparoscopic right hemicolectomy plus ERASpatients undergo Laparoscopic right hemicolectomy plus ERAS |
| ORH plus ERAS | Active comparator | Procedure: Open right hemicolectomy plus ERASpatients undergo open right hemicolectomy plus ERAS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 75 years;
- Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
- 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)
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
Key exclusion criteria (5 listed)
- 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
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic right hemicolectomy plus ERASAlso: LRH ERASpatients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs | Procedure or surgery | LRH plus ERAS |
| Open right hemicolectomy plus ERASpatients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs | Procedure or surgery | ORH plus ERAS |
Primary outcome
incidence of postoperative complications
Time frame: 30 days from surgery
The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification
3 secondary outcomes
overall survival
Time frame: 3 years
disease-free survival
Time frame: 3 years
operative mortality
Time frame: 30 days post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jiang, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic right hemicolectomy plus ERAS and Open right hemicolectomy plus ERAS in people with Colon Cancer, run by Xu jianmin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative complications (time frame: 30 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.