Management of Obstructive Colon Tumors in Istanbul | NCT05424939

Studies
Management of Obstructive Colon Tumors in Istanbul

NCT05424939

Sponsor

Istanbul Medipol University Hospital

Status

Unknown status

Last Update Posted

Jun 21, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Colon Cancer
Tumor Obstruction
Emergencies
Quality of Life

Interventions

Colectomy
Stoma procedures
By-pass/laparotomy/laparoscopy/biopsy

Countries

Turkey (Türkiye)

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

Jun 2022

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

Jun 1, 2022Actual

Primary Completion Date

May 31, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

May 11, 2022

First Submission Date that Met QC Criteria

Jun 17, 2022

First Posted Date

Jun 21, 2022Actual

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

Jun 17, 2022

Last Update Posted Date

Jun 21, 2022Actual

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

The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.

Detailed Description

Not provided

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

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Colectomy	Procedure	Colon resection
Stoma procedures	Procedure	Any type of colostomy or ileostomy with or without bowel resection
By-pass/laparotomy/laparoscopy/biopsy	Procedure	Any palliative surgery without bowel resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-to-starting chemotherapy	Surgical procedures will be compared in terms of days-to-first chemotherapy	1 year

Secondary Outcomes

Measure	Description	Time Frame
Mortality	90-day mortality	3 months
Morbidity	90-day morbidity	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT

Exclusion Criteria:

Benign diseases
Emergency surgery due to bleeding, perforation and other non-obstructive situations
Recurrent colon tumors
Rectal cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults who underwent surgery with a clinical and radiological diagnosis of obstructive colon tumors at any stage will be included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naciye Cigdem Arslan, MD	Contact	+90 531 389 09 75		cigdemarslan@hotmail.it

Overall Officials

Name	Affiliation	Role
Osman Civil, MD	Medipol University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medipol University Bahcelievler Hospital	Recruiting	Istanbul		34196	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D004630	Emergencies

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003082	Colectomy

Ancestor Terms

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided