NCT05263336

Brief Summary

The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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 3, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

January 27, 2022

Last Update Submit

March 11, 2023

Conditions

Rectal Cancer

Keywords

rectal cancerlaparoscopic anterior resectionintraoperative angiographyICG

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leak

    Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line

    Up to two weeks post surgery

Secondary Outcomes (1)

  • Postsurgical Ileus

    Up to 10 days post surgery

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intraoperative verdye green iv administration to visualize blood supply to the anastomosis

Drug: Verdye Green

Control

NO INTERVENTION

No administration of verdye green intraoperatively

Interventions

Verdye GreenDRUG

intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection

Also known as: Indocyianic Green
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • operative rectal cancer

You may not qualify if:

  • known allergy toward indocyanic green

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John Grande Hospital

Krakow, Lesser Poland Voivodeship, 31-060, Poland

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 27, 2022

First Posted

March 2, 2022

Study Start

January 3, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)