Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities

March 25, 2026 updated by: Mahmoud Rady, Theodor Bilharz Research Institute
Postoperative complications like pain, hemorrhage, anal stenosis, and incontinence, which can slow down recovery, are frequently associated with a standard hemorrhoidectomy. New procedures such the LigaSure Vessel Sealing System (LVSS) and the staplers have allowed us to perform a bloodless hemorrhoidectomy with faster recovery and less postoperative discomfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Theodor Bilharz Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years old.
  • symptomatic 4th-degree primary hemorrhoids
  • American Society of Anesthesiologists (ASA) I,II.

Exclusion Criteria:

  • who are under the age of 18 and more than 65 years old,.
  • Bleeding tendency.
  • Patients with first-, second- or third-degree piles.
  • Perianal fistula as an example of concurrent anal pathology.
  • American Society of Anesthesiologists (ASA) III, IV, and V.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LiagSure hemorroidectomy
Device: LigaSure Hemorroidectomy
Hemorroidectomy was done using the LigaSure Vessel Sealing System (LVSS)®
Active Comparator: Stapler hemorroidopexy
Device: Stapled Hemorrhoidopexy
Hemorrhoidectomy was done using the PPH stapler.
Active Comparator: Traditional hemorroidectomy
Procedure: Traditional hemorroidectomy
Hemorrhoidectomy was done using the Milligan-Morgan technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the pain score and record adverse events in the three groups. pain was measured using the visual analog scale, which consists of a 10 cm horizontal line, anchored by descriptors such as "no pain" at 0 cm and "worst imaginable pain at 10 cm,"
Time Frame: 1.5 years
A visual analog scale (VAS) was used to assess pain after surgery. Bleeding, discomfort, and urine retention were among the postoperative factors that were recorded. A Visual Analog Scale (VAS) is a validated, subjective, and continuous psychometric response scale used to measure intensity in areas like pain, fatigue, or mood. It typically consists of a 10 cm horizontal line, anchored by descriptors such as "no pain at 0 cm" and "worst imaginable pain at 10 cm," with patients marking their level.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodor Bilharz Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Fišere, Inese, et al. "Worldwide Disease-Haemorrhoids. How much do we know?." Proceedings of the Latvian Academy of Sciences. Vol. 75. No. 1. De Gruyter Poland, 2021.
  • 1- Nallajerla, Saikrishna, and Suhasin Ganta. "A comprehensive review on hemorrhoids a recto anal disorder." Pharmacologyonline 1 (2021): 270-282.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Actual)

October 5, 2025

Study Completion (Actual)

October 5, 2025

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT (719)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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