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Comparing Anugel With Gelatine Sponges for Pain Management After Hemoroidectomy

Phase 2
Completed
Conditions
Pain, Postoperative
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.

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
Primary Outcome Measures
NameTimeMethod
Pain Reduction5 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
NameTimeMethod
Use of analgesics5 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

Memorial Sisli Hospital
🇹🇷İstanbul, Sisli, Turkey

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