NCT06350370

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
20mo left

Started Jan 2019

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2019Jan 2028

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

April 5, 2024

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

April 1, 2024

Last Update Submit

April 1, 2024

Conditions

Colorectal Cancer

Keywords

Colorectal cancerNatural orifice specimen extraction surgeryMinimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of short-term complication

    Rate of complications occurred within 30 days after surgery

    30 days after surgery

Secondary Outcomes (7)

  • Operative duration

    7 days

  • Intraoperative blood loss

    7 days

  • Time to first flatus after surgery

    7 days

  • Time to first stool after surgery

    7 days

  • Length of stay after surgery

    7 days

  • +2 more secondary outcomes

Study Arms (1)

NOSES group

EXPERIMENTAL

Patients with colorectal cancer underwent transanal or transvaginal specimen extraction

Procedure: Natural orifice specimen extraction

Interventions

Natural orifice specimen extractionPROCEDURE

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

NOSES group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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";

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Xishan Wang

CONTACT

+8613552367779wxshan_cams@163.com

Mingguang Zhang

CONTACT

+8613261967603zmgslimshady@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 5, 2024

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion (Estimated)

January 1, 2028

Last Updated

April 5, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)