NCT07057076

Brief Summary

Anastomotic leak is associated with higher rates of tumor recurrence after colorectal cancer surgery. However, the mechanisms responsible remain unknown. The aim of this study is to identify associations between the peritoneal microbiome and recurrence in colorectal cancer patients with postoperative anastomotic leak. This is a single-center retrospective study of patients undergoing colorectal cancer surgery complicated with anastomotic leak between 2004 and 2012. Samples of peritoneal fluid were collected either through percutaneous drainage or reoperation, and microbiome was analyzed using whole genome shotgun. Oncological outcomes are registered. Associations between peritoneal microbiome and tumor recurrence are investigated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

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, 2004

Completed
20.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

20.4 years

First QC Date

June 29, 2025

Last Update Submit

June 29, 2025

Conditions

Colorectal Cancer Recurrent

Keywords

Colorectal cancerAnastomotic leakMicrobiomeTumor recurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Colorectal cancer recurrence after surgery

    5 years

Study Arms (1)

Colorectal cancer patients

Colorectal cancer patients operated on for cure and complicated by anastomotic leak

Eligibility Criteria

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

Colorectal cancer patients operated on for cure and complicated with anastomotic leak.

You may qualify if:

  • Colorectal cancer patients operated on for cure and complicated with anastomotic leak.

You may not qualify if:

  • Non-curative resection.
  • Urgent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peritoneal fluid

MeSH Terms

Conditions

Colorectal NeoplasmsAnastomotic LeakRecurrence

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colorectal Surgeon

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 9, 2025

Study Start

January 1, 2004

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 9, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share