The Development of Incisional Hernia in Relation to Speci... | NCT05458310

Studies
The Development of Incisional Hernia in Relation to Specimen Extraction Site After Laparoscopic Colorectal Surgeries

NCT05458310

Sponsor

Prince Sultan Military College of Health Sciences

Status

Completed

Last Update Posted

Jul 14, 2022Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Hernia

Interventions

Not provided

Countries

Saudi Arabia

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 2022

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

Jan 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Jul 11, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 14, 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

Jul 13, 2022

Last Update Posted Date

Jul 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Faisal Alboqami, Resident General Surgery, Prince Sultan Military College of Health SciencesPrincipal Investigator

Lead Sponsor

Prince Sultan Military College of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This is a retrospec/ve cohort study of colon cancer patients who underwent laparoscopic colorectal surgeries at Prince Sultan Military Medical City (PSMMC) in Riyadh, Saudi Arabia. The aim of this study is to determine the best site for specimen extrac/on with lowest risk of developing incisional hernia a0er laparoscopic colorectal surgeries.

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

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type of incision	The rate of incisional hernia development in relation to the incision site	Over 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.

Exclusion Criteria:

Duplicated data, subjects younger than 16, patients with previous abdominal surgery, and surgically complicated cases which were converted to open surgery were excluded.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study included all colorectal cancer patients over 2 years who were followed up or admitted to PSMMC under the service of colorectal surgery unit and who underwent laparoscopic low anterior resection, left colectomy or right colectomy with an age of 16 years or older.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince Sultan Military Medical City		Riyadh			Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided