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

Sponsor
Hospital de Mataró (Other)
Overall Status
Completed
CT.gov ID
NCT03383926
Collaborator
(none)
119
Enrollment
1
Location
2
Arms
94.9
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: 4.5cm suture
  • Procedure: 6cm suture
 N/A

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 Design

Study Type:
Interventional
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).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 :
Apr 4, 2004
Actual Primary Completion Date :
Feb 29, 2012
Actual Study Completion Date :
Feb 29, 2012

Arms and Interventions

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.

Outcome Measures

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) [up to 6 months]

    The distance in the staple line till the dentate line of the anal canal will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Mataró Mataró Barcelona Spain 08304

Sponsors and Collaborators

  • Hospital de Mataró

Investigators

  • Principal Investigator: Lluis Hidalgo, Hospital de Mataró

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luis Antonio Hidalgo Grau, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT03383926
Other Study ID Numbers:
  • LONGO
First Posted:
Dec 27, 2017
Last Update Posted:
Mar 14, 2018
Last Verified:
Mar 1, 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, MD, PhD, Hospital de Mataró
Longo
Hemorrhoids
Rectal
Prolapse
Anal
Additional relevant MeSH terms:
Hemorrhoids
Rectal Prolapse
Prolapse

Study Results

No Results Posted as of Mar 14, 2018