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NCT Number: NCT04527861

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 940th Hospital of Joint Logistic Support Force of Chinese of PLA, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Single-incision Laparoscopic Surgery

Procedure

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.

Other names: SILS

Conventional Laparoscopic Surgery

Procedure

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

Other names: CLS

Primary outcomes

  1. 3-year disease free survival rate

    Time frame: 36 months after surgery

    3-year disease free survival rate

Secondary outcomes

  1. Operative time

    Time frame: intraoperative

    Operative time(minutes)

  2. Intraoperative blood loss

    Time frame: intraoperative

    Estimated blood loss(milliliters,ml)

  3. Incision length

    Time frame: intraoperative

    Incision length(centimeters,cm)

  4. Total incision length

    Time frame: intraoperative

    The sum of all incision lengths(centimeters,cm)

  5. Conversion rate

    Time frame: intraoperative

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

  6. Length of stay

    Time frame: 1-14 days after surgery

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

  7. Postoperative recovery course

    Time frame: 1-14 days after surgery

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

  8. Early morbidity rate

    Time frame: 30 days after surgery

    morbidity rate 30 days after surgery

  9. Pain score

    Time frame: 1-3 days after surgery

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

  10. Tumor size

    Time frame: 14 days after surgery

    The diameter of tumors(centimeters,cm)

  11. Incisal margin

    Time frame: 14 days after surgery

    Length of proximal and distal margin (centimeters,cm)

  12. Lymph node detection

    Time frame: 14 days after surgery

    Lymph nodes harvested(numbers)

  13. Cosmetic effect

    Time frame: 1 month, 6 months and 1 year after surgery

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

  14. The quality of life-Core

    Time frame: 1 month, 6 months and 1 year after surgery

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

  15. The quality of life-Colorectal

    Time frame: 1 month, 6 months and 1 year after surgery

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

  16. 5-year overall survival rate

    Time frame: 60 months after surgery

    5-year overall survival rate

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Liu, MD

CONTACT

[email protected]

+8618121263082

Ren Zhao, MD, PHD

CONTACT

[email protected]

+8618917762018

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Changhai Hospital
  • Dongfang Hospital Affiliated to Tongji University
  • Fudan University
  • Liaoning Cancer Hospital & Institute
  • RenJi Hospital
  • Shandong Provincial Hospital
  • Shanghai Jiao Tong University School of Medicine
  • Shengjing Hospital
  • The General Hospital of Western Theater Command
  • Zhejiang Provincial People's Hospital

Registry information

Official study 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

Acronym: CSILS

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Aug 27, 2020
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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