Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Study Overview
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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.

Official Title
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Anugel vs Gelatine Sponge Clinical Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Combination Product: Anugel, Hydrogel sponge
* Combination Product: Gelatine Sponge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Haemorrhoid (grade 3-4) Exclusion Criteria: Repeating cases, additional (non haemorrhoid related) complications
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anugel<br>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<br>* A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.<br>|
| Active Comparator: Sponge<br>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<br>* A gelatine sponge is inserted in to the rectum pos hemoroidectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | 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 | The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5 | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoroidectomy