Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery

NCT07186348 | Completed DMC

• 1 other identifier: 202301650B0
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

According to the previous study, surgical intervention exhibited significant differences in daily life before and after a hemorrhoidectomy. However, post-hemorrhoidectomy pain remains a challenging problem, and the incidence of moderate to severe post-hemorrhoidectomy pain could be as high as 65%. In particular, post-hemorrhoidectomy pain management remains unsolved in 5% of cases who remains severe pain despite standard pain management which potentially leads to a longer hospital stay and more opioid requirement. Post-hemorrhoidectomy pain arises from multiple pathological mechanisms. Tissue trauma during the surgical procedure activates nociceptors in the richly innervated anal region. The subsequent inflammatory response releases cytokines, leading to localized edema and increased nerve sensitivity. Anal sphincter spasm, a common postoperative response, further exacerbates pain by creating tension around the surgical site. Additionally, defecation can mechanically irritate the wound, particularly in cases of hard stools or straining, further aggravating discomfort. The benefits of cold therapy have been recognized for thousands of years. By lowering tissue temperature through ice packing, it is believed that blood flow, pain, metabolism, and muscle spasms can be reduced, thereby minimizing inflammation and promoting the recovery of soft-tissue injuries. Ice therapy has been shown to be a safe and effective method for postoperative pain management in various procedures, including orthopedic surgery, maxillofacial surgery, laparotomy and laparoscopic surgery, thoracic surgery, hernia repair, and gynecologic of postpartum care. Our study hypothesized that the postoperative ice packing application in hemorrhoidectomy patients could help to manage post-hemorrhoidectomy pain, leading to either reduced narcotic consumption or improved pain control compared to patients who did not use ice packing application, and while ensuring patients' safety during the surgical intervention. The study aimed to assess the effectiveness of ice packing application versus the standard of care in relieving pain following hemorrhoidectomies.

Conditions

Postoperative Pain; Hemorrhoids Third Degree; Hemorrhoids Fourth Degree; Hemorrhoids

Keywords

Ice packing; Cryotherapy; Hemorrhoidectomy; Postoperative pain; Acute urine retention

Outcome Measures

Primary Outcomes (1)

• NRS pain scores

  NRS pain scores on the day of surgery and on the first postoperative day using Numeric Rating Scale(0 is equivalent to no pain and 10 indicates the worst possible pain)

  From day of surgery till postoperative day 2, assessed up to 5 years

Secondary Outcomes (4)

• Acute urine retention

  From day of surgery till postoperative day 2, assessed up to 5 years

• Postoperative bleeding

  From day of surgery up to 1 month, assessed up to 5 years

• Prolonged hospital stay

  From day of surgery up to day of discharge, assessed up to 5 years

• Opioids consumption

  From day of surgery till day of discharge, assessed up to 5 years

Study Arms (2)

Ice packing Group

ACTIVE COMPARATOR

Ice packing with standard care

Procedure: Ice packing; Procedure: Standard Care (in control arm)

Standard care group

ACTIVE COMPARATOR

Standard care

Procedure: Standard Care (in control arm)

Interventions

Ice packing PROCEDURE

10 minutes ice packing application after surgery

Also known as: Cryotherapy

Ice packing Group

Standard Care (in control arm) PROCEDURE

Standard Care (in control arm)

Ice packing Group; Standard care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with grade III or IV hemorrhoids who underwent Ferguson hemorrhoidectomy

You may not qualify if:

• Patients who also underwent additional anorectal surgeries-such as fistulectomy, ulcerectomy, isolated external skin tag excision
• Patients with incomplete data

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Keelung Branch

Keelung, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Hemorrhoids

Interventions

Cryotherapy; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: September 22, 2025
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 12, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-05

Locations

TW (1)