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Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse

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ClinicalTrials.gov Identifier: NCT03383926
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Antonio Hidalgo Grau, Hospital de Mataró

Brief Summary:
The aim of this study is to define the significance of the distance of the staple line to the dentate line of the anal canal in the efficacy of the Longo's intervention.

Condition or disease Intervention/treatment Phase
Hemorrhoids Rectal Mucosa Prolapse Procedure: 4.5cm suture Procedure: 6cm suture Not Applicable

Detailed Description:

Is going to be carried out with patients from 18 to 70 years old with hemorrhoids in a level III and IV in the Lord scale.

In the surgery Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the surgery, Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Neither the evaluator of the research and the participant do not know the lenght of the Longo's intervention that is performed.
Primary Purpose: Treatment
Official Title: Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
Actual Study Start Date : April 4, 2004
Actual Primary Completion Date : February 29, 2012
Actual Study Completion Date : February 29, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
Suture confection of theTobacco-pouch of 4.5cm from the anal margin.
Procedure: 4.5cm suture
Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.
Experimental: Group 2
Suture confection of theTobacco-pouch of 6cm from the anal margin.
Procedure: 6cm suture
Suture confection of the Tobacco-pouch of 6cm from the anal margin.



Primary Outcome Measures :
  1. Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm) [ Time Frame: up to 6 months ]
    The distance in the staple line till the dentate line of the anal canal will be measured.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men from 18 to 70 years old
  • Hemorrhoids in level III and IV in the Lord scale
  • Surgery without income and conventional hospitalization

Exclusion Criteria:

  • Previous hemorrhoidal intervention
  • Actual anal pathology

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): NCT03383926


Locations
Spain
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Hospital de Mataró
Investigators
Principal Investigator: Lluis Hidalgo Hospital de Mataró

Responsible Party: Luis Antonio Hidalgo Grau, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT03383926     History of Changes
Other Study ID Numbers: LONGO
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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

Keywords provided by Luis Antonio Hidalgo Grau, Hospital de Mataró:
Longo
Hemorrhoids
Rectal
Prolapse
Anal

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