NCT06253949

Brief Summary

We aim comparing different outcomes between high and low tie ligation of inferior mesenteric artery in left colorectal cancer operable and elective surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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 Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 4, 2024

Last Update Submit

February 4, 2024

Conditions

Keywords

colon cancerhigh tielow tieinferior mesenteric artery

Outcome Measures

Primary Outcomes (3)

  • anastomotic leakage

    yes or no

    2 weeks postoperative

  • hemorrhage

    yes or no

    2 weeks postoperative

  • rectal cancer-low anterior resection syndrome (LARS)

    yes or no

    2 weeks postoperative

Secondary Outcomes (1)

  • 1-year overall survival

    one year

Study Arms (2)

high tie ligation of inferior mesenteric artery

ACTIVE COMPARATOR

Group A patients of elective operable colorectal cancer : high tie group

Procedure: ligation of inferior mesenteric artery in colorectal cancer

low tie ligation of inferior mesenteric artery

ACTIVE COMPARATOR

Group B patients of elective operable colorectal cancer : low tie group

Procedure: ligation of inferior mesenteric artery in colorectal cancer

Interventions

This study will include two groups of patients: group (A) and (B). In group (A), the inferior mesenteric artery will be ligated at its origin (high-tie), While in group (B), it will be ligated after the origin of the left colic artery (low-tie).

high tie ligation of inferior mesenteric arterylow tie ligation of inferior mesenteric artery

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Every elective patient diagnosed with left-side colon or rectal cancer will be included in our study.

You may not qualify if:

  • Unfit patients with uncontrolled medical disease will be excluded. Patients with acute intestinal obstruction (emergency cases) and patients with extremes of age above 75 or pediatric ages will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mohamed R Mohamed, MD

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of General Surgery Faculty of Medicine

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 12, 2024

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

not yet decided

Locations