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Completed

NCT Number: NCT04057079

Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Post-operational pain is the most common problem relating to haemorrhoidectomy. This study aims to evaluate the postoperative effects of Anugel a hydrogel impregnated multi component sponge vs gelatine sponge comparatively.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sisli Hospital

Istanbul, Sisli, 34385, Turkey (Türkiye)

About this study

The patients were placed in the lithotomy position. Haemorrhoids (piles) were later located through exploration. The piles were dissected using ligasure. After completing the dissection, bleeding was controlled and either Anugel or the gelatine sponge (SpongostanTM) is inserted in to the rectum as determined by patient allocation.

The patients were monitored post operation and 5 days following the surgery. Pain was measured using the VAS scale and use of pain medication was monitored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Haemorrhoid (grade 3-4)

Exclusion criteria

  • Repeating cases, additional (non haemorrhoid related) complications

Treatment and study plan

Anugel, Hydrogel sponge

Combination Product

A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.

Gelatine Sponge

Combination Product

A gelatine sponge is inserted in to the rectum pos hemoroidectomy.

Primary outcomes

  1. Pain Reduction

    Time frame: 5 days

    Amount of pain patients feel post operation. Post surgery and on days 1 and 5 the pain felt by the patient will be measured according to the VAS scale, either in hospital or during hospital visit.

Secondary outcomes

  1. Use of analgesics

    Time frame: 5 days

    The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5

Sponsors and collaborators

Lead sponsor

Deep Life Medical Ltd

Industry

Registry information

Official study title

Anugel vs Gelatine Sponge Clinical Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2019
Registry last updated
Aug 15, 2019

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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