Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Anugel vs Gelatine Sponge Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04057079

Enrollment

110

Registered

2019-08-15

Start date

2014-04-04

Completion date

2019-02-01

Last updated

2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Hemoroidectomy

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.

Interventions

COMBINATION_PRODUCTAnugel, Hydrogel sponge

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

COMBINATION_PRODUCTGelatine Sponge

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Haemorrhoid (grade 3-4)

Exclusion criteria

* Repeating cases, additional (non haemorrhoid related) complications

Design outcomes

Primary

Measure	Time frame	Description
Pain Reduction	5 days	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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026