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Colorectal CancerCSILSNCT04527861

Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

A study testing Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer and Colon Cancer, run by Ruijin Hospital at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colorectal Cancer, Colon Cancer, Rectal Cancer
What is being tested?
Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
11 sitesChina
Study dates
8 Apr 2021to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years < age ≤85 years
  • Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
  • Pathological or highly suspected colorectal carcinoma
  • Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
  • Tumor size of 5 cm or less
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

Who cannot join

  • Body mass index (BMI) >35 kg/m2
  • The lower border of the tumor is located distal to the peritoneal reflection
  • Familial adenomatous polyposis (FAP)
  • Inflammatory bowel disease (IBD)
  • Multiple malignant colorectal tumors
  • Pregnant woman or lactating woman
Show all 11Show fewer
  • Severe mental disease
  • Previous gastrointestinal surgery (except appendectomy ）
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease
  • Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ren Zhao, MD, PHD contact

+8618917762018

zhaorensurgeon@aliyun.com

Kun Liu, MD contact

+8618121263082

lookiere@126.com

11 sites in 1 country

China11 sites, 11 recruiting

  • The General Hospital of Western Theater Command

    Chengdu, Sichuan, 610083

    Lin Zhang, MD, flysky8026@aliyun.com

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Shiliang Tu, MD, yuanhang1981@126.com

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Xiaoqiao Zhang, MD, xqz@vip.163.com

    Recruiting

  • The 940th Hospital of Joint Logistic Support Force of Chinese of PLA

    Lanzhou, Gansu, 730050

    Feng Gao, MD, gaof678@sohu.com

    Recruiting

  • Shanghai Cancer Center

    Shanghai, 200032

    Ye Xu, MD, xu_shirley021@163.com

    Recruiting

  • Dongfang Hospital Affiliated to Tongji University

    Shanghai, 200120

    Chun Song, MD, chunsong163@163.com

    Recruiting

  • RenJi Hospital

    Shanghai, 200127

    Hong Zhou, MD, renjizhouhong@163.com

    Recruiting

  • Changhai Hospital

    Shanghai, 200438

    Liqiang Hao, MD, hao_liqiang@139.com

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 201801

    Kun Liu, MD, +8618121263082, lookiere@126.com

    Recruiting

  • Shengjing Hospital

    Shenyang, Liaoning, 110004

    Hong Zhang, MD, haojiubujian1203@sina.com

    Recruiting

  • Liaoning Tumor Hospital & Institute

    Shenyang, Liaoning, 110801

    Qingtong Zhang, MD, 2690960111@qq.com

    Recruiting

Other trials in China

About this study

Official title: Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.

Read the detailed description

In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.

Being tested
Single-incision Laparoscopic Surgery, Conventional Laparoscopic Surgery
Keywords
single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-incision Laparoscopic SurgeryProcedure or surgery

    Also called SILS

    In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.

  • Conventional Laparoscopic SurgeryProcedure or surgery

    Also called CLS

    In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Study groups in NCT04527861
Study groupRoleWhat they receive
Single-incision Laparoscopic SurgeryExperimentalPatients with colorectal cancer undergo single-incision laparoscopic surgery.
Receives: Procedure: Single-incision Laparoscopic Surgery
Conventional Laparoscopic SurgeryActive comparatorPatients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）.
Receives: Procedure: Conventional Laparoscopic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease free survival rate

    3-year disease free survival rate

    Measured: 36 months after surgery

Secondary outcomes (16)

  1. Operative time

    Operative time（minutes）

    Measured: intraoperative

  2. Intraoperative blood loss

    Estimated blood loss（milliliters，ml）

    Measured: intraoperative

  3. Incision length

    Incision length（centimeters，cm）

    Measured: intraoperative

  4. Total incision length

    The sum of all incision lengths（centimeters，cm）

    Measured: intraoperative

  5. Conversion rate

    The proportion of converted to laparotomy and added trocars（%）

    Measured: intraoperative

  6. Length of stay

    The postoperative day when patients complied with the predefined discharge criteria（days after surgery）

    Measured: 1-14 days after surgery

  7. Postoperative recovery course

    Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）

    Measured: 1-14 days after surgery

  8. Early morbidity rate

    morbidity rate 30 days after surgery

    Measured: 30 days after surgery

  9. Pain score

    Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3

    Measured: 1-3 days after surgery

  10. Tumor size

    The diameter of tumors（centimeters，cm）

    Measured: 14 days after surgery

  11. Incisal margin

    Length of proximal and distal margin （centimeters，cm）

    Measured: 14 days after surgery

  12. Lymph node detection

    Lymph nodes harvested（numbers）

    Measured: 14 days after surgery

  13. Cosmetic effect

    Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied''

    Measured: 1 month, 6 months and 1 year after surgery

  14. The quality of life-Core

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Measured: 1 month, 6 months and 1 year after surgery

  15. The quality of life-Colorectal

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)

    Measured: 1 month, 6 months and 1 year after surgery

  16. 5-year overall survival rate

    5-year overall survival rate

    Measured: 60 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start8 Apr 2021
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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
710 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04527861
Sponsor's protocol ID
CSILS
Acronym
CSILS
Status last verified
Oct 2022
First submitted
19 Aug 2020
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.

    PubMed 30303873

  • Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.

    PubMed 32209897

  • Song Z, Liu K, Zhang T, Wang B, Shi Y, Jiang Y, Wang C, Chen X, Ji X, Zhao R. Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial. BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9.

    PubMed 35799145

Questions about this trial

What is this clinical trial studying?

A study testing Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer and Colon Cancer, run by Ruijin Hospital at 11 sites 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ren Zhao, MD, PHD (+8618917762018, zhaorensurgeon@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease free survival rate (time frame: 36 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04527861, which also lists 3 linked publications.

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 10 Oct 2022.

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