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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007220
Receipt No. R000008496
Scientific Title Comparison of therapeutic effect by number of access ports in laparoscopic surgery for colorectal cancer: Single-incision vs. Multi-port laparoscopic colectomy study (SIMPL study) (randomized phase II comparison study)
Date of disclosure of the study information 2012/02/06
Last modified on 2018/02/14

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Basic information
Public title Comparison of therapeutic effect by number of access ports in laparoscopic surgery for colorectal cancer: Single-incision vs. Multi-port laparoscopic colectomy study (SIMPL study) (randomized phase II comparison study)
Acronym SIMPL study
Scientific Title Comparison of therapeutic effect by number of access ports in laparoscopic surgery for colorectal cancer: Single-incision vs. Multi-port laparoscopic colectomy study (SIMPL study) (randomized phase II comparison study)
Scientific Title:Acronym SIMPL study
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of single incision laparoscopic surgery (SILS) for colorectal cancer depending on randomized phase II comparison study of early postoperative complication ratio between SILS and multiport laparoscopic surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Occurrence ratio of adverse event within postoperative one month

Key secondary outcomes Health related QOL score and patient satisfaction related to incised wound at the time of postoperative one month
Short-term outcomes including operative time, amount of blood loss, postoperative stay and amount of analgesic use
Long-term outcomes including 5-year overall survival and relapse-free survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1)Single incision laparoscopic surgery: All trocars passes a special platform via a single wound. Addition of one trocar because of transection of colon or insertion of drainage tube is allowed. It is defined when there are addition of two trocars or more as the conversion into the multi-port surgery. The application of Colon lifting technique of the securing purpose of counter traction is allowed.
Interventions/Control_2 2) Multiport laparoscopic surgery: The ports are set up up to 4-5 places at the time of beginning the operation. *When the wound length is 8cm or more, it is defined as the conversion to the open surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Adenocarcinoma in histology
2) Lymphadenectomy in radical cure is planned.
3) Tumor location is in either the cecum, ascending, sigmoid or rectosigmoid colon.
4) The minimum length of tumor is 4.0cm or less.
5) Patient is 20 years old or more to 80 years old or less.
6) Patient's performance status(ECOG) is 0-1.
7) There is not an advanced disturbance in the main internal organs function (Fill everything the following with the examination within 14 days before registration).
1. White blood cell count >=3,000/mm3 and <=12,000/ mm3
2. Platelet number >=100,000/ mm3
3. Hemoglobin >= 9.0 g/dl
4. AST(GOT) and ALT(GPT) <= standard value upper bound in institute x2.5
5.Serum total bilirubin <= 1.5 mg/dl
6.Serum creatinine <= 1.5 mg/dl
8) Informed consent with document
Key exclusion criteria 1) Severe hypersensitivity
2) Multiple cancer (Simultaneous or metachronous multiple cancer which disease-free interval is five years or less. However, a lesion of carcinoma in situ and intramucosal carcinoma are allowed.)
3) Active infectious disease
4) The past history of the mental disease and/or the central nervous system damage that becomes a clinical problem
5) Pregnant woman, lactating woman and woman who has possibility of pregnancy (intention).
6) Severe concomitant disease (Cardiorespiratory dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes melitus, liver cirrhosis and chronic hepatitis A and C, etc)
7) The past history of the organ transplantation
8) Preoperative treatment (chemotherapy, radiation therapy, and hormonal therapy, etc.) for colorectal cancer
9) Patient who judged that examination responsibility doctor is improper as subject of clinical trial
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email m_ota@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email m_ota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama Clinical Oncolgy Group (YCOG)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横須賀共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
British journal of surgery
103: 1276-81. 2016(2016/8/11)
SILC is not superior to MPLC. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 03 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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