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Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

NCT06005727 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-22

No results posted yet for this study

Summary

Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction.

A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage.

Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy.

Conditions

  • Hemorrhoids
  • Postoperative Pain
  • Postoperative Complications
  • Cryotherapy Effect

Interventions

DEVICE

Transanal ice pack

A condom is filled with 100ml of water and frozen to serve as a transanal ice pack. It is covered by sterile plastic dressing and applied to the hemorrhoidectomy wound for 1 minute after surgery is completed.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Isaac Seow-En · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005727 on ClinicalTrials.gov