Which Type of Laparoscopic Colectomy, Right or Left, Have... | NCT04461054

Studies
Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?

NCT04461054

Sponsor

Leonardo Bustamante-Lopez

Status

Unknown status

Last Update Posted

Jul 8, 2020Actual

Enrollment

332Estimated

Phase

Not provided

Conditions

Colorectal Disorders

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2020Actual

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jun 28, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonardo Bustamante-Lopez, Colorectal Coordinator of Research at the Sao Paulo University, University of Sao PauloSponsor-Investigator

Lead Sponsor

Leonardo Bustamante-LopezOTHER

Collaborators

Name	Class
Rodrigo Ambar Pinto	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.

This 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 by scale within 30 days after surgery. There were 332 patients operated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

332Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	Complications	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: patients who underwent laparoscopic right or left elective colectomy for colon adenocarcinoma.

Exclusion Criteria: Patients who underwent total colectomy

Resections that included the rectum
Exclusive transverse resections
Multivisceral resections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

colon adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonardo A Bustamante-Lopez, MD, PhD	Contact	55 11 985000091		leonardoabustamante@gmail.com

Overall Officials

Name	Affiliation	Role
Rodrigo A Pinto, MD, PhD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicine School, Sao Paulo University	Recruiting	São Paulo		05403-900	Brazil