NCT03322527

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

October 24, 2017

Last Update Submit

February 26, 2018

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

  • Goligher score

    score evaluating symptoms of haemorroidal pathology

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient with a haemorroid proloapse surgery programmed in GHPSJ

You may qualify if:

  • age \> 18
  • hemorrhoid prolapse grade 2 and 3
  • accepting participation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • DE PARADES Vincent, MD

    GHPSJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 26, 2017

Study Start

December 19, 2016

Primary Completion

April 30, 2017

Study Completion

December 31, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

FR(1)