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

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ClinicalTrials.gov Identifier: NCT03322527
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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


Condition or disease
Hemorrhoids

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery Grade II or III of Goligher
Actual Study Start Date : December 19, 2016
Primary Completion Date : April 30, 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Goligher score [ Time Frame: 1 year ]
    score evaluating symptoms of haemorroidal pathology


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with a haemorroid proloapse surgery programmed in GHPSJ
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322527


Locations
France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Principal Investigator: DE PARADES Vincent, MD GHPSJ
More Information

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03322527     History of Changes
Other Study ID Numbers: HLASER
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prolapse
Hemorrhoids
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases