NCT03557528

Brief Summary

During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

June 4, 2018

Last Update Submit

June 4, 2018

Conditions

Rectosigmoid Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • effectivenes of lymphnode dissection

    number of dissected lymphnodes

    3 years

Secondary Outcomes (1)

  • complication

    3 years

Study Arms (2)

Group 1

High Ligation of Inferior mesenteric artery

Procedure: Laparoscopic colorectal resection

Group 2

Low ligation of inferior mesenteric artery with skeletonization at its origin

Procedure: Laparoscopic colorectal resection

Interventions

Laparoscopic colorectal resectionPROCEDURE

Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes

Group 1Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients affectced by clinical stage I-III cancer of sigmoid and rectum.

You may qualify if:

  • stage I-III carcinoma

You may not qualify if:

  • stage IV
  • Urgent resection
  • conversion to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Umberto I

Roma, 00161, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 15, 2018

Study Start

January 1, 2014

Primary Completion

December 31, 2016

Study Completion

April 30, 2017

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)