Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Combination Product: Anugel, Hydrogel sponge; Combination Product: Gelatine Sponge

• Registration Number: NCT04057079
• Lead Sponsor: Deep Life Medical Ltd

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.

Study Timeline

• Study Start: 2014-04-04
• Primary Completion: 2018-07-09
• Study Completion: 2019-02-01
• Study First Submitted: 2019-05-01
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Haemorrhoid (grade 3-4)

Exclusion Criteria

• Repeating cases, additional (non haemorrhoid related) complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anugel	Anugel, Hydrogel sponge	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.
Sponge	Gelatine Sponge	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sisli Hospital; 🇹🇷 İstanbul, Sisli, Turkey