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NCT05953662Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
28 Jun 2023
Start date
1 Sept 2023
Primary completion date
1 Apr 2025
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT number
NCT05953662

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 1 Sept 2023 to the primary completion date, 1 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Joint organ resection is required;
  • Continuous systemic steroid therapy within 1 months;

Other illness

  • Combined with simultaneous or heterogeneous (within 5 years) malignant tumors;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery;
  • Suffering from a serious mental illness;
  • Patients with severe emphysema, interstitial pneumonia or ischemic heart disease, etc. who cannot tolerate surgery;
  • Patients or families are unable to understand the conditions and objectives of this study.

Age

  • Age \< 18, or \> 80 years old;

Other

  • ASA Class IV or V;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Sixth Affiliated Hospital, Sun Yatsen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.