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
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids Rectal Mucosa Prolapse||Procedure: 4.5cm suture Procedure: 6cm suture||Not Applicable|
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|
|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.|
|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|
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.
- 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.
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
|Hospital de Mataró|
|Mataró, Barcelona, Spain, 08304|
|Principal Investigator:||Lluis Hidalgo||Hospital de Mataró|