search
Back to results

Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Verdye Green
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, laparoscopic anterior resection, intraoperative angiography, ICG

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • operative rectal cancer

Exclusion Criteria:

  • known allergy toward indocyanic green

Sites / Locations

  • St John Grande HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

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

No administration of verdye green intraoperatively

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postsurgical Ileus
Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery

Full Information

First Posted
January 27, 2022
Last Updated
March 11, 2023
Sponsor
Jagiellonian University
search

1. Study Identification

Unique Protocol Identification Number
NCT05263336
Brief Title
Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum
Official Title
The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, laparoscopic anterior resection, intraoperative angiography, ICG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
Arm Title
Control
Arm Type
No Intervention
Arm Description
No administration of verdye green intraoperatively
Intervention Type
Drug
Intervention Name(s)
Verdye Green
Other Intervention Name(s)
Indocyianic Green
Intervention Description
intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection
Primary Outcome Measure Information:
Title
Anastomotic leak
Description
Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line
Time Frame
Up to two weeks post surgery
Secondary Outcome Measure Information:
Title
Postsurgical Ileus
Description
Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery
Time Frame
Up to 10 days post surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: operative rectal cancer Exclusion Criteria: known allergy toward indocyanic green
Facility Information:
Facility Name
St John Grande Hospital
City
Kraków
State/Province
Lesser Poland
ZIP/Postal Code
31-060
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawel Bogacki
Phone
0048667177677
Email
pawel.bogacki@uj.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

We'll reach out to this number within 24 hrs