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OpenTrials
Completed

NCT Number: NCT07481812

Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities

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.

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Key information

Conditions

Piles Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Theodor Bilharz Research Institute

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LigaSure Hemorroidectomy

Device

Hemorroidectomy was done using the LigaSure Vessel Sealing System (LVSS)®

Stapled Hemorrhoidopexy

Device

Hemorrhoidectomy was done using the PPH stapler.

Traditional hemorroidectomy

Procedure

Hemorrhoidectomy was done using the Milligan-Morgan technique

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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