NCT06294470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

January 30, 2024

Last Update Submit

March 4, 2024

Conditions

HemorrhoidsDefecation Disorder

Keywords

HemorrohoidsObstructive Defecation SyndromeStapled hemorrhoidopexy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative change of the balloon expulsion test

    1 month

  • Postoperative change of the colonic transit time

    1 month

Study Arms (2)

Experimental

EXPERIMENTAL

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

Diagnostic Test: Ballon expulsion testDiagnostic Test: Colonic transit timeProcedure: Stapled hemorrhodopexy

Control

ACTIVE COMPARATOR

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

Diagnostic Test: Ballon expulsion testDiagnostic Test: Colonic transit timeProcedure: Stapled hemorrhodopexy

Interventions

Ballon expulsion testDIAGNOSTIC_TEST

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

ControlExperimental
Colonic transit timeDIAGNOSTIC_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.

ControlExperimental
Stapled hemorrhodopexyPROCEDURE

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

ControlExperimental

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Domingo Luciani

Caracas, Miranda, 1073, Venezuela

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cristopher Varela, MD

    Instituto Venezolano de los Seguros Sociales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 30, 2024

First Posted

March 5, 2024

Study Start

May 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

VE(1)