HemorrhoidsNCT06294470
Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome
A study testing Ballon expulsion test, Colonic transit time and Stapled hemorrhodopexy in people with Hemorrhoids and Defecation Disorder, run by Universidad Central de Venezuela at 1 site in Venezuela.
Trial summary
The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids, Defecation Disorder
- What is being tested?
- Ballon expulsion test, Colonic transit time and Stapled hemorrhodopexy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 May 2023to 15 Dec 2023
- 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
- Patients aged between 18 and 70 years old.
- Patients diagnosed with grade II to IV mucohemorrhoidal disease and suffering from symptoms of obstructed defecation, which require a procedure for prolapse and hemorrhoidal pexia.
- Patients with a minimum Altomare Score of 3pts and Agachan Score Wexner of at least 12pts.
Who cannot join
- Patients who, after undergoing a colonic transit time study, are found to have a different type of constipation (such as slow transit or colonic inertia).
- Patients who undergo PPH technique along with another anorectal procedure.
- Patients with any other anorectal conditions, including fistula, anal fissure, inflammatory bowel disease, chronic diarrhea, or malignant lesions.
- Patients diagnosed with mucohemorrhoidal disease and experiencing acute complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome.
The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse.
Read the detailed description
In 1998, Longo introduced a new technique called the stapled hemorrhoidal prolapse and pexia procedure (PPH) to treat mucohemorrhoidal disease. According to Longo, hemorrhoidal prolapse is always associated with internal rectal prolapse, which can be a symptom of defecation obstruction syndrome. The PPH technique aims to correct these symptoms by removing the mucosal segment and pexiing the hemorrhoids, thus eliminating excess rectal tissue. This improves the resting surface tension of the rectal mucosa, making defecation easier and improving defecatory obstruction.
The research focused on applying theoretical concepts related to defecatory obstruction secondary to mucohemorrhoidal prolapse, which results in difficulties with an adequate defecatory act. The main objective was to determine if surgery for hemorrhoidal prolapse and pexia could correct the symptoms of obstructed defecation, as proposed by Longo. The study established facilities to evaluate and provide pre- and postoperative follow-up to patients with symptoms of defecatory obstruction. The research question posed was: "In patients with mucohemorrhoidal disease and symptoms of defecatory obstruction, can the PPH technique improve the symptoms of defecatory obstruction?"
To carry out the research, a questionnaire was used to collect epidemiological, clinical, and functional data from patients with grade II to IV mucohemorrhoidal disease who had surgical indication for PPH. The Constipation Scores questionnaire (Altomare and Agachan-Wexner) was used to identify patients with symptoms of defecatory obstruction. The sample was divided into two groups: an experimental group, which included patients with symptoms of defecatory obstruction, and a control group, made up of patients without such symptoms. Functional studies were carried out, such as colonic transit time and the balloon expulsion test. Subsequently, the PPH technique was performed, and after one month postoperatively, the Constipation Scores and functional studies were evaluated to determine if there was an improvement in the initial scores.
The study was designed as a quasi-experimental study and was also supported by an analytical case-control study. Its aim was to assess patients with grades II to IV mucohemorrhoidal disease who required PPH.
- Conditions
- Hemorrhoids, Defecation Disorder
- Being tested
- Ballon expulsion test, Colonic transit time, Stapled hemorrhodopexy
- Keywords
- Hemorrohoids, Obstructive Defecation Syndrome, Stapled hemorrhoidopexy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballon expulsion testDiagnostic test
Rectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (<1 or >1 min).
Colonic transit timeDiagnostic test
Patients ingested capsules with 24 radiopaque markers and underwent standing abdominal radiographs on Day 3 and Day 5. Over 80% expulsion within five days was considered normal, while retention indicated defecatory obstruction.
Stapled hemorrhodopexyProcedure or surgery
Circumferential stapled hemorrhoidopexy with a 34mm circular stapler is a surgical procedure used to treat mucohemorrhoidal prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts Receives: Diagnostic Test: Ballon expulsion test; Diagnostic Test: Colonic transit time; Procedure: Stapled hemorrhodopexy |
| Control | Active comparator | Altomare Score score <3pts and Agachan Wexner Score <12pts Receives: Diagnostic Test: Ballon expulsion test; Diagnostic Test: Colonic transit time; Procedure: Stapled hemorrhodopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative improvement of symptoms of defecatory obstruction
Change From Baseline in Altomare Score and Agachan Wexner Score [Time Frame: 1 month]. Altomare Score: Assessed using an interviewer-led questionnaire with eight items (time spent at toilet, attempts to defecate each day, digitation, laxatives, enemas, straining, consistency, completeness), each rated on a 3- or 4-point Likert scale. Scores range from 0 (no symptoms) to 3 or 4 (severe symptoms), with a max score of 31 indicating obstructive defecatory syndrome (>3). Higher scores denote worse symptoms. Agachan Wexner Score: Derived from eight variables (Frequency of bowel movements, effort, Completeness, pain, time, assistance, failure, history), scored from 0 to 4 (except "assistance for defecation," 0-2). Global score is the sum, with >12 indicating constipation symptoms. Higher scores indicate worse defecatory obstruction symptoms.
Measured: 1 month
Secondary outcomes (2)
Postoperative change of the balloon expulsion test
Time recorded (<1 or >1 min) in ballon expulsion test in control and experimental group.
Measured: 1 month
Postoperative change of the colonic transit time
Over 80% expulsion of 24 radiopaque markers on standing abdominal radiographs within five days
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 May 2023
- Primary completion30 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Central de Venezuela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristopher Varela, Universidad Central de Venezuela
- Investigators
- Cristopher Varela, MD, Principal investigator, Instituto Venezolano de los Seguros Sociales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294470
- Sponsor's protocol ID
- 01-2023
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome.
- ClinicalTrials.gov ID
- NCT06294470
- Acronym / sponsor ID
- 01-2023
- Conditions
- Hemorrhoids, Defecation Disorder
- Keywords
- Hemorrohoids, Obstructive Defecation Syndrome, Stapled hemorrhoidopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad Central de VenezuelaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 5 Mar 2024 (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 objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse.
Detailed description
In 1998, Longo introduced a new technique called the stapled hemorrhoidal prolapse and pexia procedure (PPH) to treat mucohemorrhoidal disease. According to Longo, hemorrhoidal prolapse is always associated with internal rectal prolapse, which can be a symptom of defecation obstruction syndrome. The PPH technique aims to correct these symptoms by removing the mucosal segment and pexiing the hemorrhoids, thus eliminating excess rectal tissue. This improves the resting surface tension of the rectal mucosa, making defecation easier and improving defecatory obstruction.
The research focused on applying theoretical concepts related to defecatory obstruction secondary to mucohemorrhoidal prolapse, which results in difficulties with an adequate defecatory act. The main objective was to determine if surgery for hemorrhoidal prolapse and pexia could correct the symptoms of obstructed defecation, as proposed by Longo. The study established facilities to evaluate and provide pre- and postoperative follow-up to patients with symptoms of defecatory obstruction. The research question posed was: "In patients with mucohemorrhoidal disease and symptoms of defecatory obstruction, can the PPH technique improve the symptoms of defecatory obstruction?"
To carry out the research, a questionnaire was used to collect epidemiological, clinical, and functional data from patients with grade II to IV mucohemorrhoidal disease who had surgical indication for PPH. The Constipation Scores questionnaire (Altomare and Agachan-Wexner) was used to identify patients with symptoms of defecatory obstruction. The sample was divided into two groups: an experimental group, which included patients with symptoms of defecatory obstruction, and a control group, made up of patients without such symptoms. Functional studies were carried out, such as colonic transit time and the balloon expulsion test. Subsequently, the PPH technique was performed, and after one month postoperatively, the Constipation Scores and functional studies were evaluated to determine if there was an improvement in the initial scores.
The study was designed as a quasi-experimental study and was also supported by an analytical case-control study. Its aim was to assess patients with grades II to IV mucohemorrhoidal disease who required PPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Ballon expulsion test, Diagnostic Test: Colonic transit time, Procedure: Stapled hemorrhodopexyAltomare Score score ≥3pts and Agachan Wexner Score ≥12pts |
| Control | Active comparator | Diagnostic Test: Ballon expulsion test, Diagnostic Test: Colonic transit time, Procedure: Stapled hemorrhodopexyAltomare Score score <3pts and Agachan Wexner Score <12pts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 70 years old.
- Patients diagnosed with grade II to IV mucohemorrhoidal disease and suffering from symptoms of obstructed defecation, which require a procedure for prolapse and hemorrhoidal pexia.
- Patients with a minimum Altomare Score of 3pts and Agachan Score Wexner of at least 12pts.
Key exclusion criteria (4 listed)
- Patients who, after undergoing a colonic transit time study, are found to have a different type of constipation (such as slow transit or colonic inertia).
- Patients who undergo PPH technique along with another anorectal procedure.
- Patients with any other anorectal conditions, including fistula, anal fissure, inflammatory bowel disease, chronic diarrhea, or malignant lesions.
- Patients diagnosed with mucohemorrhoidal disease and experiencing acute complications.
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 |
|---|---|---|
| Ballon expulsion testRectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (<1 or >1 min). | Diagnostic test | Control, Experimental |
| Colonic transit timePatients ingested capsules with 24 radiopaque markers and underwent standing abdominal radiographs on Day 3 and Day 5. Over 80% expulsion within five days was considered normal, while retention indicated defecatory obstruction. | Diagnostic test | Control, Experimental |
| Stapled hemorrhodopexyCircumferential stapled hemorrhoidopexy with a 34mm circular stapler is a surgical procedure used to treat mucohemorrhoidal prolapse. | Procedure or surgery | Control, Experimental |
Primary outcome
Postoperative improvement of symptoms of defecatory obstruction
Time frame: 1 month
Change From Baseline in Altomare Score and Agachan Wexner Score [Time Frame: 1 month]. Altomare Score: Assessed using an interviewer-led questionnaire with eight items (time spent at toilet, attempts to defecate each day, digitation, laxatives, enemas, straining, consistency, completeness), each rated on a 3- or 4-point Likert scale. Scores range from 0 (no symptoms) to 3 or 4 (severe symptoms), with a max score of 31 indicating obstructive defecatory syndrome (>3). Higher scores denote worse symptoms. Agachan Wexner Score: Derived from eight variables (Frequency of bowel movements, effort, Completeness, pain, time, assistance, failure, history), scored from 0 to 4 (except "assistance for defecation," 0-2). Global score is the sum, with >12 indicating constipation symptoms. Higher scores indicate worse defecatory obstruction symptoms.
2 secondary outcomes
Postoperative change of the balloon expulsion test
Time frame: 1 month
Postoperative change of the colonic transit time
Time frame: 1 month
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 5 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Cristopher Varela, MD principal investigator
Instituto Venezolano de los Seguros Sociales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballon expulsion test, Colonic transit time and Stapled hemorrhodopexy in people with Hemorrhoids and Defecation Disorder, run by Universidad Central de Venezuela at 1 site in Venezuela.
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 4 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 5 Mar 2024. 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 Venezuela. 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?
Postoperative improvement of symptoms of defecatory obstruction (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.