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NCT Number: NCT06350370

Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study

Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathological diagnosis of primary malignant tumor in the colon or rectum;
  • The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";

Exclusion criteria

  • Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
  • The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".

Treatment and study plan

Natural Orifice Specimen Extraction

Procedure

We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction

Primary outcomes

  1. Rate of short-term complication

    Time frame: 30 days after surgery

    Rate of complications occurred within 30 days after surgery

Secondary outcomes

  1. Operative duration

    Time frame: 7 days

    Total time of the operation

  2. Intraoperative blood loss

    Time frame: 7 days

    Estimated blood loss during the surgery

  3. Time to first flatus after surgery

    Time frame: 7 days

    Time to first flatus after surgery

  4. Time to first stool after surgery

    Time frame: 7 days

    Time to first stool after surgery

  5. Length of stay after surgery

    Time frame: 7 days

    Length of stay after surgery

  6. 3-year disease free survival

    Time frame: 3 year

    3-year disease free survival

  7. 3-year overall survival

    Time frame: 3 year

    3-year overall survival

Study contacts

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

Mingguang Zhang

CONTACT

[email protected]

+8613261967603

Xishan Wang

CONTACT

[email protected]

+8613552367779

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
Apr 5, 2024

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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