An interventional study of Ballon expulsion test and Colonic transit time in Hemorrhoids and Defecation Disorder, sponsored by Universidad Central de Venezuela. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Universidad Central de Venezuela · Not applicable, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Universidad Central de Venezuela is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts
Diagnostic Test: Ballon expulsion test · Diagnostic Test: Colonic transit time · Procedure: Stapled hemorrhodopexy
Altomare Score score \<3pts and Agachan Wexner Score \<12pts
Diagnostic Test: Ballon expulsion test · Diagnostic Test: Colonic transit time · Procedure: Stapled hemorrhodopexy
Rectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (\<1 or \>1 min).
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.
Circumferential stapled hemorrhoidopexy with a 34mm circular stapler is a surgical procedure used to treat mucohemorrhoidal prolapse.
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.
Time frame: 1 month
Postoperative change of the balloon expulsion test
Time recorded (\<1 or \>1 min) in ballon expulsion test in control and experimental group.
Time frame: 1 month
Postoperative change of the colonic transit time
Over 80% expulsion of 24 radiopaque markers on standing abdominal radiographs within five days
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Nov 2023, 6 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 6 months is below that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Universidad Central de Venezuela