Back to resultsComparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Anugel, Hydrogel sponge
Gelatine Sponge
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Hemoroidectomy
Eligibility Criteria
Inclusion Criteria:
- Haemorrhoid (grade 3-4)
Exclusion Criteria:
- Repeating cases, additional (non haemorrhoid related) complications
Sites / Locations
- Memorial Sisli Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anugel
Sponge
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Use of analgesics
The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04057079
Brief Title
Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy
Official Title
Anugel vs Gelatine Sponge Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 4, 2014 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deep Life Medical Ltd
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Hemoroidectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anugel
Arm Type
Experimental
Arm Description
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.
Arm Title
Sponge
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Anugel, Hydrogel sponge
Intervention Description
A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.
Intervention Type
Combination Product
Intervention Name(s)
Gelatine Sponge
Intervention Description
A gelatine sponge is inserted in to the rectum pos hemoroidectomy.
Primary Outcome Measure Information:
Title
Pain Reduction
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Use of analgesics
Description
The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5
Time Frame
5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Haemorrhoid (grade 3-4)
Exclusion Criteria:
Repeating cases, additional (non haemorrhoid related) complications
Facility Information:
Facility Name
Memorial Sisli Hospital
City
İstanbul
State/Province
Sisli
ZIP/Postal Code
34385
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy
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