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Completed

NCT Number: NCT06294470

Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Domingo Luciani

Caracas, Miranda, 1073, Venezuela

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ballon expulsion test

Diagnostic Test

Rectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (<1 or >1 min).

Colonic transit time

Diagnostic 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 hemorrhodopexy

Procedure

Circumferential stapled hemorrhoidopexy with a 34mm circular stapler is a surgical procedure used to treat mucohemorrhoidal prolapse.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative change of the balloon expulsion test

    Time frame: 1 month

    Time recorded (<1 or >1 min) in ballon expulsion test in control and experimental group.

  2. Postoperative change of the colonic transit time

    Time frame: 1 month

    Over 80% expulsion of 24 radiopaque markers on standing abdominal radiographs within five days

Sponsors and collaborators

Lead sponsor

Universidad Central de Venezuela

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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