Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06460402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
Sponsor:
E-DA Hospital
Organization:
Study Overview
Official Title:
Comparing Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the effectiveness of cryotherapy and warm water sitz bath in post-hemorrhoidectomy wound care. It is a prospective, randomized controlled trial that will assess the impact of these two methods on postoperative pain, analgesic use, wound separation, and swelling.
Detailed Description:
Background: Hemorrhoids are a common anorectal condition. For patients with severe or intolerable symptoms, surgical excision (hemorrhoidectomy) is an effective treatment. However, postoperative pain, swelling, and wound complications are common issues that may delay recovery. Currently, warm water sitz baths are recommended for pain relief and healing, but some studies suggest cryotherapy may be an effective alternative by reducing inflammation and swelling. This trial aims to systematically compare the effects of these two therapies.
Objectives:
Primary: Assess and compare pain levels (VAS) and total analgesic consumption between the two groups at different postoperative time points.
Secondary: Evaluate and compare wound separation incidence at 1-week follow-up and wound swelling at different time points.
Methods:
Design: Prospective, randomized, parallel-controlled trial with 1:1 allocation. Subjects: 128 symptomatic hemorrhoid patients (18-75 years old) undergoing hemorrhoidectomy, randomized into cryotherapy or sitz bath group.
Intervention: Cryotherapy group - ice packs for 20 min every 2h within 48h post-op. Sitz bath group - warm water baths 2-3 times daily for 15-20 min.
Outcome measures: Pain VAS scores, analgesic consumption, wound separation rate, swelling assessment at different time points.
Expected results and benefits: Cryotherapy is hypothesized to result in lower pain scores, reduced analgesic use, lower wound separation incidence and milder swelling compared to sitz baths. This may lead to improved postoperative recovery and quality of life for patients.
Risks and management: Potential mild adverse reactions like skin irritation, temporary nerve stimulation will be closely monitored and appropriately managed. The study will be terminated for any severe adverse events.
Statistical analysis: Repeated measures ANOVA for VAS scores and analgesic use. Chi-square or Fisher's exact test for wound separation rates. Descriptive statistics for baseline characteristics.
In summary, this well-designed randomized control trial aims to provide high-quality evidence comparing cryotherapy and sitz baths in post-hemorrhoidectomy care, potentially identifying a superior treatment option to improve patient outcomes and experiences.
Objectives:
Primary: Assess and compare pain levels (VAS) and total analgesic consumption between the two groups at different postoperative time points.
Secondary: Evaluate and compare wound separation incidence at 1-week follow-up and wound swelling at different time points.
Methods:
Design: Prospective, randomized, parallel-controlled trial with 1:1 allocation. Subjects: 128 symptomatic hemorrhoid patients (18-75 years old) undergoing hemorrhoidectomy, randomized into cryotherapy or sitz bath group.
Intervention: Cryotherapy group - ice packs for 20 min every 2h within 48h post-op. Sitz bath group - warm water baths 2-3 times daily for 15-20 min.
Outcome measures: Pain VAS scores, analgesic consumption, wound separation rate, swelling assessment at different time points.
Expected results and benefits: Cryotherapy is hypothesized to result in lower pain scores, reduced analgesic use, lower wound separation incidence and milder swelling compared to sitz baths. This may lead to improved postoperative recovery and quality of life for patients.
Risks and management: Potential mild adverse reactions like skin irritation, temporary nerve stimulation will be closely monitored and appropriately managed. The study will be terminated for any severe adverse events.
Statistical analysis: Repeated measures ANOVA for VAS scores and analgesic use. Chi-square or Fisher's exact test for wound separation rates. Descriptive statistics for baseline characteristics.
In summary, this well-designed randomized control trial aims to provide high-quality evidence comparing cryotherapy and sitz baths in post-hemorrhoidectomy care, potentially identifying a superior treatment option to improve patient outcomes and experiences.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: