Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Pain, Postoperative Clinical Trial

Official title:

Anugel vs Gelatine Sponge Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057079
• Other study ID #: Anugel20170420
• Status: Completed
• Phase: Phase 2
• Start date: April 4, 2014
• Est. completion date: February 1, 2019

Study information

• Verified date: August 2019
• Source: Deep Life Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 1, 2019
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Haemorrhoid (grade 3-4)

Exclusion Criteria:

• Repeating cases, additional (non haemorrhoid related) complications

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Combination Product:
• Anugel, Hydrogel sponge
A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.
• Gelatine Sponge
A gelatine sponge is inserted in to the rectum pos hemoroidectomy.

Locations

Country	Name	City	State
Turkey	Memorial Sisli Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Deep Life Medical Ltd

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Use of analgesics	The frequency and dose of analgesics for pain management is monitored post operation, on day 1 and day 5	5 days