NCT06588374

Brief Summary

The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

August 31, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

February 26, 2024

Last Update Submit

September 4, 2024

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

  • Effect of Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy on post operative complications

    To assess postoperative pain intensity by Numberical rating scale 0 To 10

    Baseline

Study Arms (2)

Hemorrhoidectomy Only

EXPERIMENTAL

Hemorrhoids by Hemorrhoidectomy alone

Procedure: lateral internal sphincterotomy

Hemorrhoidectomy With Lateral Internal Sphincterotomy

EXPERIMENTAL

hemorroids by lateral internal sphincterotomy and hemorrhoidectomy

Procedure: lateral internal sphincterotomy

Interventions

lateral internal sphincterotomyPROCEDURE

Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy

Hemorrhoidectomy OnlyHemorrhoidectomy With Lateral Internal Sphincterotomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Surgically fit according to ASA.
  • Cases with hemorrhoids Grade ll\& III \& IV.
  • Age between (18-60).

You may not qualify if:

  • Age less than 18 years old.
  • Complete rectal prolapse.
  • Grade I hemorrhoids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hemorrhoids

Interventions

Lateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Officials

  • ashraf A Helmy, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Mohamed, Resident

CONTACT

0115122942401024691101mm@gmail.com

Mohamed A Mohamed, Lecturer

CONTACT

01098904323abulfetouh@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: hemorrhoidectomy alone versus hemorrhoidectomy with lateral internal sphincterotomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

February 26, 2024

First Posted

September 19, 2024

Study Start

August 31, 2024

Primary Completion

March 1, 2025

Study Completion

August 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09