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Not yet recruitingNCT06588374Updated Sep 19, 2024

Hemorrhoidectomy Only Versus Hemorrhoidectomy With Lateral Internal Sphincterotomy

An interventional study of lateral internal sphincterotomy in Hemorrhoids, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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

Read the detailed description

Hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 O clock positions (with the patient in lithotomy position) . The most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . Lateral internal sphincterotomy is one good technique. It reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . The addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. These patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .

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Conditions studied

  • Hemorrhoids

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03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Age less than 18 years old.
  2. Complete rectal prolapse.
  3. Grade I hemorrhoids.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Hemorrhoidectomy Only

    Hemorrhoids by Hemorrhoidectomy alone

    Procedure: lateral internal sphincterotomy

  • Experimental
    Hemorrhoidectomy With Lateral Internal Sphincterotomy

    hemorroids by lateral internal sphincterotomy and hemorrhoidectomy

    Procedure: lateral internal sphincterotomy

Interventions

  • Procedurelateral internal sphincterotomy

    Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy

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What researchers measure

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

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06588374
Lead sponsor
Assiut University
Responsible party
Mohamed Mamdouh Mohamed Ahmed (Resident Doctor, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Aug 31, 2024 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Mohamed M Mohamed, Resident
Contact
01024691101mm@gmail.com
01151229424
Mohamed A Mohamed, Lecturer
Contact
abulfetouh@aun.edu.eg
01098904323
ashraf A Helmy, professor
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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