Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

August 12, 2019 updated by: Deep Life Medical Ltd

Anugel vs Gelatine Sponge Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

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

  • Turkey
    • Sisli
      • İstanbul, Sisli, Turkey, 34385
        • Memorial Sisli Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Haemorrhoid (grade 3-4)

Exclusion Criteria:

  • Repeating cases, additional (non haemorrhoid related) complications

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Combination product: Anugel, Hydrogel sponge
A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.
Active Comparator: 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.
Combination product: Gelatine Sponge
A gelatine sponge is inserted in to the rectum pos hemoroidectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days

Collaborators and Investigators

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

Sponsor

Deep Life Medical Ltd

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 4, 2014

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anugel20170420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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