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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03322527
First Posted: October 26, 2017
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
  Purpose

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
Hemorrhoids

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

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


Estimated Enrollment: 40
Actual Study Start Date: December 19, 2016
Estimated Study Completion Date: December 2017
Primary Completion Date: April 30, 2017 (Final data collection date for primary outcome measure)
  Eligibility

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 Submitted: October 24, 2017
First Posted: October 26, 2017
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