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.
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.
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.
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.
- First posted14 Jan 2021
- Study start12 Jan 2021
- Primary completion12 Feb 2021
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent De Parades, MD, Principal investigator, Fondation Hôpital Saint-Joseph
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 21932016van 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Doppler Ligation With Mucopexy in the Treatment of Internal Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT04708678
- Acronym / sponsor ID
- HEM_THD / HEM_THD
- Conditions
- Hemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 14 Jan 2021 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate
Time frame: Months 60
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.
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 27 Apr 2023.
- Results publication: PubMed 21932016Riss 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.
- Results publication: PubMed 32067353van 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.
- Recommandations pour la pratique clinique sur le traitement de la maladie hémorroïdaireLink provided by the sponsor.
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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.
Vincent De Parades, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
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.