Short-term and Oncological Outcomes of Laparoscopic Color... | NCT04716062

Studies
Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients

NCT04716062

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Completed

Last Update Posted

Jan 20, 2021Actual

Enrollment

138Actual

Phase

Not provided

Conditions

Obesity
Colorectal Cancer

Interventions

Open or Laparoscopic-assisted Colorectal surgery

Countries

Italy

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jan 14, 2021

First Submission Date that Met QC Criteria

Jan 17, 2021

First Posted Date

Jan 20, 2021Actual

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

Jan 17, 2021

Last Update Posted Date

Jan 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gianluigi Giannelli, Medical Doctor, Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Detailed Description

A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

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

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subjects who underwent open-air surgery		Fifty-one (37%) out of 138 subjects underwent open-air surgery.	Procedure: Open or Laparoscopic-assisted Colorectal surgery
subjects underwent laparoscopic-assisted surgery		A total of 87 (63%) out of 138 subjects underwent laparoscopic-assisted surgery.	Procedure: Open or Laparoscopic-assisted Colorectal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open or Laparoscopic-assisted Colorectal surgery	Procedure	Colorectal surgery	subjects underwent laparoscopic-assisted surgery subjects who underwent open-air surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization	days	baseline
Lymph Nodes number	Lymph Nodes number	baseline
Clavien Dindo score (post-operative complications)	1 to 5 point	baseline

Secondary Outcomes

Measure	Description	Time Frame
Age	years	Baseline
Body mass index	Kilograms/m2	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index >25 Kg/m2
Colorectal cancer (CRC)

Exclusion Criteria:

Current emergency conditions (i.e., perforation and\or occlusion)
Pregnancy,
Co-existing peritoneal carcinomatosis
Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
Prior transverse resections

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

138 overweight or obese subjects. Fifty-one (37%) subjects underwent open-air surgery and 87 (63%) to VL surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Gastroenterology IRCCS S. de Bellis		Castellana Grotte	Bari	70132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided