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Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities

Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07481812
Enrollment
90
Registered
2026-03-19
Start date
2024-04-05
Completion date
2025-10-05
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Piles

Brief summary

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.

Interventions

DEVICELigaSure Hemorroidectomy

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

Hemorrhoidectomy was done using the PPH stapler.

PROCEDURETraditional hemorroidectomy

Hemorrhoidectomy was done using the Milligan-Morgan technique

Sponsors

Theodor Bilharz Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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,"1.5 yearsA 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026