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CompletedNCT03383926Updated Mar 14, 2018

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

An interventional study of 4.5cm suture and 6cm suture in Hemorrhoids and Rectal Mucosa Prolapse, sponsored by Hospital de Mataró. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Hospital de Mataró · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 13 years 5 months after the study started (first participant enrolled Apr 2004, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hemorrhoids
  • Rectal Mucosa Prolapse

Keywords

  • Longo
  • Hemorrhoids
  • Rectal
  • Prolapse
  • Anal
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's enrollment of 119 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Hospital de Mataró is the lead sponsor of 27 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous hemorrhoidal intervention
  • Actual anal pathology
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    Group 1

    Suture confection of theTobacco-pouch of 4.5cm from the anal margin.

    Procedure: 4.5cm suture

  • Experimental
    Group 2

    Suture confection of theTobacco-pouch of 6cm from the anal margin.

    Procedure: 6cm suture

Interventions

  • Procedure4.5cm suture

    Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.

  • Procedure6cm suture

    Suture confection of the Tobacco-pouch of 6cm from the anal margin.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 6 months

07

Study locations

1 site
  • Hospital de Mataró
    Mataró, Barcelona 08304, Spain
08

References and documents

Publications

  • 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. PubMed 32647985 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2004 to primary completion in Feb 2012, 94 months.

Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 94 months is above that.

Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2017
First posted
Dec 27, 2017
StartActual
Apr 4, 2004
Primary completionActual
Feb 29, 2012
CompletionActual
Feb 29, 2012
Last update
Mar 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03383926
Lead sponsor
Hospital de Mataró
Responsible party
Luis Antonio Hidalgo Grau (MD, PhD, Hospital de Mataró) — Principal investigator
First posted
Dec 27, 2017
Start date
Apr 4, 2004
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012
Last update
Mar 14, 2018

Study contacts

Lluis Hidalgo
principal investigator · Hospital de Mataró

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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