Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Deep Life Medical

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Combination Product: Gelatine Sponge; Combination Product: Anugel, Hydrogel sponge

Study type: Interventional

Funder types: Industry

Identifiers

NCT04057079

Anugel20170420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haemorrhoid (grade 3-4)

Exclusion criteria

• Repeating cases, additional (non haemorrhoid related) complications

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Anugel

Experimental group

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.

Treatment:

Combination Product: Anugel, Hydrogel sponge

Sponge

Active Comparator group

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.

Treatment:

Combination Product: Gelatine Sponge