Back to resultsLongo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
Primary Purpose
Hemorrhoids, Rectal Mucosa Prolapse
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
4.5cm suture
6cm suture
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring Longo, Hemorrhoids, Rectal, Prolapse, Anal
Eligibility 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
Sites / Locations
- Hospital de Mataró
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Suture confection of theTobacco-pouch of 4.5cm from the anal margin.
Suture confection of theTobacco-pouch of 6cm from the anal margin.
Outcomes
Primary Outcome Measures
Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm)
The distance in the staple line till the dentate line of the anal canal will be measured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03383926
Brief Title
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
Official Title
Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2004 (Actual)
Primary Completion Date
February 29, 2012 (Actual)
Study Completion Date
February 29, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Rectal Mucosa Prolapse
Keywords
Longo, Hemorrhoids, Rectal, Prolapse, Anal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Suture confection of theTobacco-pouch of 4.5cm from the anal margin.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Suture confection of theTobacco-pouch of 6cm from the anal margin.
Intervention Type
Procedure
Intervention Name(s)
4.5cm suture
Intervention Description
Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.
Intervention Type
Procedure
Intervention Name(s)
6cm suture
Intervention Description
Suture confection of the Tobacco-pouch of 6cm from the anal margin.
Primary Outcome Measure Information:
Title
Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm)
Description
The distance in the staple line till the dentate line of the anal canal will be measured.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluis Hidalgo
Organizational Affiliation
Hospital de Mataró
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32647985
Citation
Hidalgo-Grau LA, Piedrafita-Serra E, Ruiz-Edo N, Llorca-Cardenosa S, Heredia-Budo A, Estrada-Ferrer O, Sunol-Sala X. Prospective Randomized Study on Stapled Anopexy Height and Its Influence on Recurrence for Hemorrhoidal Disease Treatment. World J Surg. 2020 Nov;44(11):3936-3942. doi: 10.1007/s00268-020-05676-y.
Results Reference
derived
Learn more about this trial
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
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