HemorrhoidsNCT03383926
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
A study testing 4.5cm suture and 6cm suture in people with Hemorrhoids and Rectal Mucosa Prolapse, run by Hospital de Mataró at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids, Rectal Mucosa Prolapse
- What is being tested?
- 4.5cm suture and 6cm suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2004to 29 Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous hemorrhoidal intervention
- Actual anal pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
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).
- Conditions
- Hemorrhoids, Rectal Mucosa Prolapse
- Being tested
- 4.5cm suture, 6cm suture
- Keywords
- Longo, Hemorrhoids, Rectal, Prolapse, Anal
- Medical subject headings
- Hemorrhoids, Rectal Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4.5cm sutureProcedure or surgery
Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.
6cm sutureProcedure or surgery
Suture confection of the Tobacco-pouch of 6cm from the anal margin.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Suture confection of theTobacco-pouch of 4.5cm from the anal margin. Receives: Procedure: 4.5cm suture |
| Group 2 | Experimental | Suture confection of theTobacco-pouch of 6cm from the anal margin. Receives: Procedure: 6cm suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start4 Apr 2004
- Primary completion29 Feb 2012
- Study completion29 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Antonio Hidalgo Grau, Hospital de Mataró
- Investigators
- Lluis Hidalgo, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383926
- Sponsor's protocol ID
- LONGO
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
- ClinicalTrials.gov ID
- NCT03383926
- Acronym / sponsor ID
- LONGO
- Conditions
- Hemorrhoids, Rectal Mucosa Prolapse
- Keywords
- Longo, Hemorrhoids, Rectal, Prolapse, Anal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 4 Apr 2004 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: 4.5cm sutureSuture confection of theTobacco-pouch of 4.5cm from the anal margin. |
| Group 2 | Experimental | Procedure: 6cm sutureSuture confection of theTobacco-pouch of 6cm from the anal margin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Previous hemorrhoidal intervention
- Actual anal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4.5cm sutureSuture confection of the Tobacco-pouch of 4.5cm from the anal margin. | Procedure or surgery | Group 1 |
| 6cm sutureSuture confection of the Tobacco-pouch of 6cm from the anal margin. | Procedure or surgery | Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 32647985Hidalgo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluis Hidalgo principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4.5cm suture and 6cm suture in people with Hemorrhoids and Rectal Mucosa Prolapse, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.