NCT06294470

Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universidad Central de Venezuela · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ballon expulsion test	Rectal latex balloon probe filled with saline solution. Patients expelled balloon and time recorded (\<1 or \>1 min).
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-11-30
• Completion: 2023-12-15
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Venezuela