UMIN-CTR Clinical Trial

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
Email	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
Email	nabe-jun@comet.ocn.ne.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	Yokohama City University Ethics Committee
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
Tel	045-370-7627
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008496