Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome

Hemorrhoids Clinical Trial

Official title:

Efficacy of the Hemorrhoidal Prolapse and Pexia Procedure for the Treatment of Defecatory Obstruction Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294470
• Other study ID #: 01-2023
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2024
• Source: Universidad Central de Venezuela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 15, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Diagnostic Test:
• Ballon expulsion test
Rectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (<1 or >1 min).
• Colonic transit time
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.

Procedure:
• Stapled hemorrhodopexy
Circumferential stapled hemorrhoidopexy with a 34mm circular stapler is a surgical procedure used to treat mucohemorrhoidal prolapse.

Locations

Country	Name	City	State
Venezuela	Hospital Domingo Luciani	Caracas	Miranda

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Central de Venezuela

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	Postoperative change of the balloon expulsion test	Time recorded (<1 or >1 min) in ballon expulsion test in control and experimental group.	1 month
Secondary	Postoperative change of the colonic transit time	Over 80% expulsion of 24 radiopaque markers on standing abdominal radiographs within five days	1 month