Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

NCT04057079 | Completed Phase 2 DMC

• 1 other identifier: Anugel20170420
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Hemoroidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Use of analgesics

  5 days

Study Arms (2)

Anugel

EXPERIMENTAL

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

Sponge

ACTIVE COMPARATOR

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

Interventions

Anugel, Hydrogel sponge COMBINATION_PRODUCT

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

Anugel

Gelatine Sponge COMBINATION_PRODUCT

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

Sponge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Haemorrhoid (grade 3-4)

You may not qualify if:

• Repeating cases, additional (non haemorrhoid related) complications

Sponsors & Collaborators

• Deep Life Medical Ltd: lead

Study Sites (1)

Memorial Sisli Hospital

Istanbul, Sisli, 34385, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: August 15, 2019
• Study Start: April 4, 2014
• Primary Completion: July 9, 2018
• Study Completion: February 1, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

TU (1)