NCT04461054

Brief Summary

Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy. Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both procedures. Methods: Retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified with scale within 30 days after surgery. Grade III or greater was considered serious complication. Quality of oncologic resection was assessed by the average number of lymph nodes harvested and surgical margins.

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
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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 2, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

June 28, 2020

Last Update Submit

July 1, 2020

Conditions

Colorectal Disorders

Keywords

colectomycolorectallaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Complications

    30 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

colon adenocarcinoma

You may not qualify if:

  • Resections that included the rectum
  • Exclusive transverse resections
  • Multivisceral resections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine School, Sao Paulo University

São Paulo, 05403-900, Brazil

RECRUITING

Study Officials

  • Rodrigo A Pinto, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo A Bustamante-Lopez, MD, PhD

CONTACT

55 11 985000091leonardoabustamante@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Colorectal Coordinator of Research at the Sao Paulo University

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 8, 2020

Study Start

January 2, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations

BR(1)