Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome

NCT ID: NCT06294470

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-12-15

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Altomare Score score ≥3pts and Agachan Wexner Score ≥12pts

Group Type: EXPERIMENTAL

Ballon expulsion test

Intervention Type: DIAGNOSTIC_TEST

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

Colonic transit time

Intervention Type: 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

Intervention Type: PROCEDURE

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

Control

Altomare Score score \<3pts and Agachan Wexner Score \<12pts

Group Type: ACTIVE_COMPARATOR

Ballon expulsion test

Intervention Type: DIAGNOSTIC_TEST

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

Colonic transit time

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

Ballon expulsion test

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Stapled hemorrhodopexy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Central de Venezuela

OTHER

Sponsor Role: lead

Responsible Party

Cristopher Varela

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristopher Varela, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Venezolano de los Seguros Sociales

Locations

Hospital Domingo Luciani

Caracas, Miranda, Venezuela

Countries

Venezuela

Other Identifiers

01-2023

Identifier Type: -

Identifier Source: org_study_id