UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007220 |
|---|---|
| Receipt number | 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 | 2021/05/06 12:23:37 |
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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 | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
nabe-jun@comet.ocn.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
Tel
045-370-7627
nextjim1@yokohama-cu.ac.jp
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
SILC is not superior to MPLC.
1.Even though the results of the 5-year OS and RFS in this trial were exploratory and underpowered, there were no statistically significant differences between the SILC and MPC arms. SILC may be an acceptable treatment option for select patients with colon cancer.
Results date posted
| 2020 | Year | 08 | Month | 11 | Day |
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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 26 | Day |
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
British journal of surgery 103: 1276-81. 2016(2016/8/11)
1.Long-term Outcomes of a Randomized Controlled Trial of Single-incision Versus Multi-port Laparoscopic Colectomy for Colon Cancer.
Watanabe J, Ishibe A, Suwa H,Ota M,Fujii S, Kubota K, Kunisaki C, Endo I.
Ann Surg. 2021 Jan 28. doi: 10.1097/SLA.0000000000004252. Online ahead of print.
2.The comparison of health-related quality of life and patient satisfaction between single-incision and multiport laparoscopic colectomy for cancer: A sub-study of a randomized, prospective clinical trial.
Ohya H, Watanabe J, Suwa Y, Suwa H, Ozawa M, Ishibe A, Fujii S, Kubota K, Kunisaki C, Endo I.
Ann Gastroenterol Surg. 2020 Jul 23;4(6):684-692. doi: 10.1002/ags3.12378. eCollection 2020 Nov.
3.Hernia incidence following a randomized clinical trial of single-incision versus multi-port laparoscopic colectomy.
Watanabe J, Ishibe A, Suwa Y, Suwa H, Ota M, Kubota K, Yamanaka T, Kunisaki C, Endo I.
Surg Endosc. 2020 May 20. doi: 10.1007/s00464-020-07656-8. Online ahead of print.
RESULT:
2.Single-incision laparoscopic colectomy was similar to multiport laparoscopic colectomy in terms of health-related quality of life and patient satisfaction. However, single-incision laparoscopic colectomy may be inferior than multiport laparoscopic colectomy in terms of the role emotional.
3.We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port.
Management information
Registered date
| 2012 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008496
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