Evaluation of Laparoscopic Cholecystectomy and Concomitan... | NCT06317779

Studies
Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair

NCT06317779

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Mar 19, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Abdominal Disorder

Interventions

Not provided

Countries

Not provided

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Feb 1, 2026Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Feb 16, 2024

First Submission Date that Met QC Criteria

Mar 12, 2024

First Posted Date

Mar 19, 2024Actual

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

Mar 12, 2024

Last Update Posted Date

Mar 19, 2024Actual

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

Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy.

Detailed Description

Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin.

The use of laparoscopy in abdominal surgeries increases for its great benefits over open surgery as:

1)faster recovery, 2)shorter hospital stays 3)decrease blood loss, 4)decreased postoperative pain 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits. few studies discuss the efficacy and safety of using Laparoscopy in management of lap cholecyctectomy and concomitant paraumbilical hernia repair

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair	the incidence of recurrence of hernia	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes measures	Decrease duration of operation by doing two by hours minutes operation at same session	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia

Exclusion Criteria:

Patients with associated diseases such as chronic pulmonary disease, cardiac disease, chronic renal failure.

patients with strangulated para-umbilical hernia

patients with recurrent paraumbilical hernia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Moustafa M Fazary	Contact	01021790211		mm0982429@gmail.com
Mahmoud H Abdelrazzek	Contact	+20 102 087 1478		MISdr.hasaboo@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed M Ali	General surgery	Study Director

Locations

Not provided