NCT05911152

Brief Summary

The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2016

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

8 years

First QC Date

June 12, 2023

Last Update Submit

June 24, 2023

Conditions

Colorectal Cancer

Keywords

Colorectal cancerMinimally invasive surgeryLaparoscopic surgeryIntracorporeal anastomosis

Outcome Measures

Primary Outcomes (2)

  • 3-year disease free survival

    Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery

    3 year

  • 3-year overall survival

    Percentage of patients who are still alive at the end of a 3-year period after surgery

    3 year

Secondary Outcomes (5)

  • Rate of postoperative complications

    30 days

  • Time to first flatus after surgery

    7 days

  • Time to first stool after surgery

    7 days

  • Length of stay after surgery

    30 days

  • Postoperative pain score

    3 days

Study Arms (2)

Intracorporeal anastomosis

Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis

Procedure: Intracorporeal anastomosis

Extracorporeal anastomosis

Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis

Interventions

Intracorporeal anastomosisPROCEDURE

Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection

Intracorporeal anastomosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis

You may qualify if:

  • Patients voluntarily enrolled in this study and signed an informed consent form;
  • Age: 18-75 years;
  • Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;
  • Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;
  • Preoperative staging as cT1-3NanyM0;
  • Underwent laparoscopic surgery.

You may not qualify if:

  • Contraindications to laparoscopic surgery;
  • Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;
  • Patients with distant metastasis;
  • Patients with multiple primary colorectal cancers;
  • Patients with a history of malignancy;
  • Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.

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

Related Publications (1)

  • Zhang M, Dong S, Wang L, Liu Z, Zhou H, Liu Q, Chen Y, Tang J, Wang X. Short-term and long-term outcomes of intracorporeal anastomosis in laparoscopic segmental left colectomy for splenic flexure cancer - a multicenter retrospective cohort study of 342 cases. Int J Surg. 2024 Mar 1;110(3):1595-1604. doi: 10.1097/JS9.0000000000000974.

    PMID: 38085798DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mingguang Zhang, Dr.

CONTACT

+8613261967603zmgslimshady@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 20, 2023

Study Start

January 1, 2016

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations

CN(1)