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Postoperative PainICE-HEMONCT07186348

Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery

A study testing Ice packing in people with Postoperative Pain and Hemorrhoids Third Degree, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Any age
What is being tested?
Ice packing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
429 participants
Where
1 siteTaiwan
Study dates
1 Jan 2021to 12 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung Memorial Hospital, Keelung Branch

    Keelung, Taiwan

Other trials in Taiwan

About this study

Official title: Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery: A Propensity Score-Matched Study

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.

Read more

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.

Read the detailed description

Data were collected from patients diagnosed with grade III or IV hemorrhoids who underwent surgical intervention between January 2021 and September 2022 at the Keelung branch of Chang Gung Memorial Hospital, Taiwan. Clinical demographic data, medication history, hemorrhoid-related characteristics, operative details, postoperative pain scores, and outcomes were retrieved from the hospital's electronic medical records. Patient demographics and medication histories-including age, gender, American Society of Anesthesiologists (ASA) classification, Eastern Cooperative Oncology Group (ECOG) performance status, body mass index (BMI), tobacco use, and comorbidities-were recorded. Hemorrhoid-related characteristics, such as symptoms, disease grading, and the number of hemorrhoidectomy quadrants, were also documented. Operative characteristics and postoperative outcomes were recorded, including length of hospital stay, number of outpatient department (OPD) visits, operative time and surgical devices used, complications, painkiller usage, and postoperative Numeric Rating Scale (NRS) pain score. Postoperative complications included acute urinary retention (AUR), bleeding, stool impaction, prolonged hospital stay, and readmission rates were also recorded. All patients were followed until September 2023 or until follow-up visits were no longer required. The median follow-up period was 2 months. All data collection and analysis procedures were approved by the Institutional Review Board of Chang Gung Memorial Hospital, Taiwan (IRB No. 202301650B0).

This retrospective cohort study initially included 480 consecutive patients with grade III or IV hemorrhoids who underwent surgical intervention. Patients who also underwent additional anorectal surgeries-such as fistulectomy (n=16), ulcerectomy (n=14), isolated external skin tag excision (n=3)-or had incomplete data (n=18) were excluded, leaving 429 patients eligible for inclusion. Ice packing was introduced and application starting in August 2021. Based on the surgery date, patients were divided into two groups: the standard care group (before August 2021) and the ice packing group (after August 2021). To address selection bias inherent to this non-randomized study and achieve balanced covariates across the groups, propensity score matching (PSM) was performed using a logistic regression model, with the use of ice packing as the dependent variable. Patients in both groups were matched based on clinical characteristics, including sex, age, ASA, BMI, smoking status, comorbidities, disease grading, number of hemorrhoidectomy quadrants, surgical device, and postoperative pain management. A 1:1 PSM was conducted using the nearest neighbor matching method with a caliper width of 0.2.

All patients underwent standard preoperative preparation and pre-anesthesia evaluation. Surgical procedures were performed by five experienced surgeons, with the operation's extent determined by hemorrhoid grading. LigaSure™, a single-use, self-funded energy device, was used with patient consent. Patients taking anticoagulants (e.g., Clopidogrel, apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin) were instructed to discontinue their medications 5 to 7 days before surgery and resume them 24 to 48 hours post-surgery. Antiplatelet agents, such as aspirin, were continued during the perioperative period.

The surgical procedure was as follows: patients were positioned in the Sims position under mask-induced general anesthesia. A digital examination and anoscopy were performed, followed by an injection of lidocaine and adrenaline (10,000:1) to provide additional local anesthesia and facilitate mucosal dissection. Hemorrhoid complexes requiring excision were clearly identified. The Ferguson procedure was then performed. For patients opting for LigaSure™-assisted hemorrhoidectomy, excision and dissection followed the same protocol using the device. After achieving adequate hemostasis, the apex of each hemorrhoid pedicle was suture-ligated, and the mucosal and skin wounds were closed with 4-0 Polysorb™ sutures. At the conclusion of the procedure, sebacoyl dinalbuphine ester (SDE), a single-dose, extended-release nalbuphine prodrug, was administered as self-funded analgesia with patient consent. In the ice packing group, a 10-minute ice packing application was performed postoperatively. The ice packing device, featuring a tissue fluid collection plastic test tube and condom, is illustrated in Figure 2, and Figure 3 illustrates the diagram utilized during the surgical procedure.

Post-surgery, intravenous fluids were discontinued upon waking from anesthesia. Patients were prescribed 1000 mg of mefenamic acid with 250 mg of magnesium oxide, taken four times daily. Sitz baths and wound care with neomycin ointment were performed twice daily as part of the routine postoperative care protocol. Morphine (5 mg) was administered via intramuscular injection every 6 hours if wound pain was intolerable. Additionally, parecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, was offered as self-funded analgesia via intravenous injection every 12 hours with patient consent. Patients were discharged on postoperative days 1 to 3 following smooth urination.

Being tested
Ice packing, Standard Care (in control arm)
Keywords
Ice packing, Cryotherapy, Hemorrhoidectomy, Postoperative pain, Acute urine retention
Medical subject headings
Pain, Postoperative, Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ice packingProcedure or surgery

    Also called Cryotherapy

    10 minutes ice packing application after surgery

  • Standard Care (in control arm)Procedure or surgery

    Standard Care (in control arm)

Study groups in NCT07186348
Study groupRoleWhat they receive
Ice packing GroupActive comparatorIce packing with standard care
Receives: Procedure: Ice packing; Procedure: Standard Care (in control arm)
Standard care groupActive comparatorStandard care
Receives: Procedure: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (4)
  1. Acute urine retention

    The sudden inability to void, usually associated with bloating, severe urgency, general distress, lower abdominal distension, and suprapubic pain

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

  2. Postoperative bleeding

    Bleeding occurring after completion of a surgical procedure, which may occur immediately or may be delayed, and which may or may not be wound related

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

  3. Prolonged hospital stay

    A hospital admission that lasts longer than what is considered typical or expected for a particular condition or procedure. In patients particularly post-hemorrhoidectomy, 3 days admission is expected.

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

  4. Opioids consumption

    Opioids consumption in administration frequency(n) and total doses(mg) needed for pain control post-hemorrhoidectomy

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Jan 2021
  3. Primary completion30 Sep 2022
  4. Study completion12 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186348
Sponsor's protocol ID
202301650B0
Acronym
ICE-HEMO
Status last verified
May 2025
First submitted
8 Jun 2025
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ice packing in people with Postoperative Pain and Hemorrhoids Third Degree, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NRS pain scores (time frame: From day of surgery till postoperative day 2, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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