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NCT Number: NCT05953662

Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer

Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China

About this study

Colorectal cancer is the third most common malignant tumor. In 2020, there were nearly 1.9 million new cases worldwide, accounting for about 10% of all new malignant tumors, and the related death exceeded 900,000. In recent years, the incidence of colorectal cancer in our country has been rising rapidly year by year, with more than 400,000 new cases each year, leading China to the largest number of colorectal cancer cases in the world. For resectable non-metastatic colorectal cancer, radical surgical resection is the mainstay of treatments. Compared with the open surgery, the laparoscopic colorectal cancer resection has smaller wounds, faster postoperative recovery, and shorter hospital stay. The 10-year results of the COLOR trial showed similar DFS, OS, and recurrence rates between open and laparoscopic surgery for colon cancer. In another trial (COST study), 872 patients with colon cancer were randomly assigned to open surgery or laparoscopic-assisted colectomy for curative colon cancer. After a median follow-up of 7 years, the 5-year recurrence rates and the 5-year OS rates were similar.

Traditional laparoscopic colorectal cancer resection can be carried out smoothly by close cooperation between the surgeon and the assistant. However, inexperienced assistants are likely to cause parainjuries due to the opposite field of the view and the narrow operating space. In recent years, single-port laparoscopy gradually goes into service. However, it is easy to cause instrument conflicts, straight-line viewing angles, and lack of traction. Therefore, single-port surgery is extremely unergonomic and difficult for the surgeon. Reduced-port laparoscopic surgery has been selectively used in some colon cancer anticipants. Reduced-port laparoscopic surgery reduces or completely eliminates the assistant's operating ports, and the surgeon mainly relies on himself/herself to complete the exposure of the operative field. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery is completed by the left and right hands of the surgeon, which is easier to coordinate, avoiding the prolongation of the operation time or even concomitant injury caused by the poor cooperation of the inexperienced assistant and the surgeon. Reduced-port laparoscopy reduces some surgical incisions, and extreme minimally invasive may result in less pain and faster recovery. From an economic point of view, the reduced-port laparoscopy reduces some surgical consumables and human resouce, leading to reduced cost of surgery.

In order to further explore the application of reduced-port laparoscopic surgery in patients with resectable colorectal cancer, the center plans to carry out a clinical study of 'reduced-port laparoscopic surgery versus traditional laparoscopic surgery for resectable colorectal cancer', aiming to evaluate the complications associated with perioperative surgery, R0 resection rate, 3-year disease-free survival rate, and 3-year overall survival rate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80 years old;
  • Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma);
  • Eastern Cooperative Oncology Group (ECOG) is 0-1 points;
  • Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis;
  • No other multiple primary tumors;
  • No organ dysfunction;
  • The patient and his/her family are able to understand the study protocol and are willing to participate in the study and sign informed consent.

Exclusion criteria

  • Age < 18, or > 80 years old;
  • Combined with simultaneous or heterogeneous (within 5 years) malignant tumors;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery;
  • Joint organ resection is required;
  • ASA Class IV or V;
  • Suffering from a serious mental illness;
  • Patients with severe emphysema, interstitial pneumonia or ischemic heart disease, etc. who cannot tolerate surgery;
  • Continuous systemic steroid therapy within 1 months;
  • Patients or families are unable to understand the conditions and objectives of this study.

Treatment and study plan

Reduced-port laparoscopic surgery

Procedure

compare different operational styles of colon and upper rectal cancer

Conventional Laparoscopic Surgery

Procedure

conventional laparoscopic surgery

Primary outcomes

  1. DFS rate

    Time frame: 1 year

    Disease-free survival rate

Secondary outcomes

  1. Total opertaion time

    Time frame: through opertation completion, an average of 2 hours

    Time from surgery started to surgery ended

  2. Intraoperative blood loss

    Time frame: through study completion, an average of 50 ml

    Blood loss during operation

  3. Postoperative hospital stay

    Time frame: through anticipants discharged, an average of 7 days

    Day from operation finished to patient discharged

  4. Postoperative complication rate

    Time frame: 30 days

    Any complication associated with operation based on Clavien-Dindo classification

  5. Postoperative mortality

    Time frame: 30 days

    Death associated with operation

  6. 3 years DFS Rate

    Time frame: 3 years

    Disease-free survival rate

  7. 3 years OS Rate

    Time frame: 3 years

    Overall survival rate

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer --an Open Label, Multicenter, Prospective Phase Ⅱ Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Apr 27, 2026

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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