Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

NCT ID: NCT04057079

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-04

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Research staff used a computer-based tool to allocate the ligasure haemorrhoidectomy patients randomly to either Group 1 (n=56) who received standard anal gelatine sponge (SpongostanTM) or Group 2 (n-54) to a layered hydrogel sponge (AnugelTM) following surgery. Encryption concealed the allocation until the patient's details had been logged.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Anugel

In this arm, after the surgery a hydrogel impregnated sponge will be placed in the rectum.

The patient is evaluated after the operation and the following day when the sponge is removed.

A hydrogel impregnated foam pad is applied on the surface of the wound the following 5 days.

The patient is evaluated on post op, on day 1 (usually before discharge) and day 5

The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored.

Group Type EXPERIMENTAL

Anugel, Hydrogel sponge

Intervention Type COMBINATION_PRODUCT

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

Sponge

Currently used treatment method i.e. insertion of gelatine sponge in to the rectum post operation.

The patient is evaluated on post op, on day 1 (usually before discharge) and day 5

The pain of the patients are evaluated according to the VAS scale and the use of analgesics and opioids is monitored.

Group Type ACTIVE_COMPARATOR

Gelatine Sponge

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Anugel, Hydrogel sponge

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

Intervention Type COMBINATION_PRODUCT

Gelatine Sponge

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Haemorrhoid (grade 3-4)

Exclusion Criteria

* Repeating cases, additional (non haemorrhoid related) complications
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Life Medical Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Memorial Sisli Hospital

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Anugel20170420

Identifier Type: -

Identifier Source: org_study_id

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