Evaluation of the Technique LHP (Laser HemorrhoidoPlasty)... | NCT03322527

Studies
Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery

NCT03322527

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Hemorrhoids

Interventions

Not provided

Countries

France

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

Feb 2018

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

Dec 19, 2016Actual

Primary Completion Date

Apr 30, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 24, 2017

First Posted Date

Oct 26, 2017Actual

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

Feb 26, 2018

Last Update Posted Date

Feb 27, 2018Actual

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

Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery.

The aim is to evaluate the efficacy of this technic and note the post surgery pain and events

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

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Goligher score	score evaluating symptoms of haemorroidal pathology	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18
hemorrhoid prolapse grade 2 and 3
accepting participation

Exclusion Criteria:

hemorrhoid prolapse grade 1 and 4
other proctological pathology
previous surgery of prolapsus
with anti coagulant treatment
Intestinal chronic inflammatory disease
age < 18
pregnancy

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

patient with a haemorroid proloapse surgery programmed in GHPSJ

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DE PARADES Vincent, MD	GHPSJ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided