AzTrials
AzTrials

HemorrhoidsHEM_THDNCT04708678

Long-term Efficacy of Doppler Ligation With Mucopexy in the Treatment of Internal Hemorrhoidal Disease

An observational study of Hemorrhoids, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A classic distinction is made between internal and external hemorrhoidal pathology. External hemorrhoids can present with thrombosis, which causes painful swelling; internal hemorrhoids by rectal bleeding, prolapse, and more rarely thrombosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoids
How many people
151 participants
Where
1 siteFrance
Study dates
12 Jan 2021to 26 Apr 2023
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with hemorrhoidal pathology operated, between November 2012 and October 2015, by the technique of arterial ligatures under Doppler control with mucopexy

Who may be able to join

  • Patient whose age is ≥ 18 years
  • Patient with hemorrhoidal pathology
  • Patient operated, between November 2012 and October 2015, by the technique of arterial ligatures under doppler control with mucopexy
  • French-speaking patient

Who cannot join

  • Patient with failure of the technique (defined by the non-reduction in bleeding and / or prolapse scores during the first 3 postoperative months and beyond).
  • Patient with a psychiatric pathology likely to influence the follow-up.
  • Patient under guardianship or curatorship.
  • Patient deprived of liberty.
  • Patient under legal protection
  • Patient objecting to the use of their data for this research.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

A classic distinction is made between internal and external hemorrhoidal pathology. External hemorrhoids can present with thrombosis, which causes painful swelling; internal hemorrhoids by rectal bleeding, prolapse, and more rarely thrombosis. Hemorrhoidal pathology is one of the most frequent reasons for consultation in proctology. Its prevalence is probably underestimated due to taboos and the frequent self-medication of patients, but it is considered high in the general population.

The therapeutic management of internal or external hemorrhoidal pathology is primarily based on hygiene and dietetic measures and regularization of transit. In the case of external hemorrhoidal pathology, treatment may also include Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and topical treatment (anesthetic or topical corticosteroid). For internal hemorrhoidal pathology, when these measures are insufficient or when prolapse is present from the outset, instrumental treatment can be offered, allowing the bleeding and / or prolapse to be treated up to grade 3 maximum. This treatment includes sclerosis (less and less practiced), infrared photocoagulation and rubber band ligation. In 10 to 20% of cases, when the prolapse is irreducible, there is anemia of hemorrhoidal origin or the symptoms persist despite well-conducted treatment, surgical treatment may be offered.

Read more

The reference surgical technique in France and in Europe is tripedicular hemorrhoidectomy according to the Milligan and Morgan technique, developed at Saint Marks Hospital in London, first published in 1937. It has the advantage of to be the most effective technique, with a low rate of postoperative recurrence and treats both internal and external hemorrhoidal pathology. However, the postoperative period is painful, requires local care and requires cessation of activity for several weeks. On the other hand, there is a risk of potentially serious complications and permanent sequelae: acute retention of urine (2.1-15%), hemorrhage (0.6-5.4%), anal stenosis (6%) , infection (0.5-5%) and anal incontinence (0-6%). Patient selection is essential and contraindicates hemorrhoidectomy in cases of anal incontinence, active suppuration, chronic inflammatory bowel disease, anal intercourse or a history of pelvic radiotherapy.

As an alternative to hemorrhoidectomy, and its painful and restrictive consequences, new minimally invasive surgical techniques that have proven their effectiveness in the treatment of internal hemorrhoidal pathology have emerged over the past twenty years. The two main ones are Longo circular stapling hemorrhoidopexy and Doppler-controlled arterial ligations with mucopexy. Several studies have shown that Longo's hemorrhoidopexy causes less postoperative pain and allows a faster return to activity than after a tripedicular hemorrhoidectomy. On the other hand, the rate of recurrence of hemorrhoidal pathology was higher. This rate was 41% at 12 years and 47.5% at 15 years. In addition, specific and severe complications have been described as rectal perforations, rectovaginal fistulas, perirectal hematomas, pelvic cellulitis, peritonitis and death.

Several comparative studies have shown that arterial ligation under Doppler control with mucopexy was less painful postoperatively than hemorrhoidopexy by circular stapling and that the short- and medium-term efficacy was generally similar. In addition, the postoperative consequences of arterial ligatures under Doppler control with mucopexy seem harmless, with none of the major complications described after stapled hemorrhoidopexy. For these reasons, arterial ligation is now tending to replace hemorrhoidopexy with circular stapling.

The objective of our study is to assess the rate of recurrence of long-term hemorrhoidal pathology in patients who have had arterial ligatures under Doppler control with mucopexy at our center. The results will help guide the practitioner and the patient in the choice of surgical treatment.

Conditions
Hemorrhoids
Medical subject headings
Hemorrhoids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate

    this outcome corresponds to the cumulative recurrence rate of symptoms of hemorrhoidal pathology, more than 60 months after performing arterial ligations under Doppler control with mucopexy.

    Measured: Months 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start12 Jan 2021
  3. Primary completion12 Feb 2021
  4. Study completion26 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708678
Sponsor's protocol ID
HEM_THD
Acronym
HEM_THD
Status last verified
Apr 2023
First submitted
12 Jan 2021
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

    PubMed 21932016
  • van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, Higuero T, Muris JWM, Breukink SO. European Society of ColoProctology: guideline for haemorrhoidal disease. Colorectal Dis. 2020 Jun;22(6):650-662. doi: 10.1111/codi.14975. Epub 2020 Feb 17.

    PubMed 32067353

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhoids, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 4 inclusion and 6 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 27 Apr 2023. 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 France. 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?

Recurrence rate (time frame: Months 60). 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 NCT04708678, which also lists 2 linked publications.

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 27 Apr 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in