HemorrhoidsNCT07843563
Ice Packing Versus Warm Sitz Baths After Hemorrhoidectomy
A study testing Cryotherapy (Ice Packing) and Warm Sitz Bath in people with Hemorrhoids and Postoperative Pain, run by Memorial Atasehir Hospital at 1 site in Turkey (Türkiye).
Trial summary
Warm sitz baths are commonly recommended after hemorrhoidectomy, although their benefit for early postoperative recovery remains uncertain. Local cold application may reduce postoperative pain and perianal swelling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Postoperative Pain
- What is being tested?
- Cryotherapy (Ice Packing) and Warm Sitz Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Primary hemorrhoidal disease requiring Ferguson hemorrhoidectomy.
- American Society of Anesthesiologists (ASA) physical status class I or II.
- Ability to understand the study instructions, provide written informed consent, and comply with the assigned postoperative intervention and follow-up schedule.
- -
Who cannot join
- Recurrent hemorrhoidal disease.
- Concurrent anal pathology, including anal fistula, anal fissure, or anal polyp.
- History of chronic pain.
- Regular analgesic use.
- Cognitive impairment that could interfere with pain assessment or adherence to the study protocol.
- Documented allergy or intolerance to the study materials.
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- Additional surgical procedures performed together with Ferguson hemorrhoidectomy.
- Comorbidities that could affect pain perception or the postoperative course, including diabetes mellitus, liver cirrhosis, inflammatory bowel disease, documented neuropathy, or coagulation disorders.
- ASA physical status class III or higher.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Atasehir Hospital
Istanbul, Kadıköy, 34734
About this study
Official title: Ice Packing Versus Warm Sitz Baths After Ferguson Hemorrhoidectomy: A Randomized Controlled Trial
Warm sitz baths are commonly recommended after hemorrhoidectomy, although their benefit for early postoperative recovery remains uncertain. Local cold application may reduce postoperative pain and perianal swelling.
This prospective, two-center, randomized controlled trial compared ice packing with warm sitz baths in patients undergoing Ferguson hemorrhoidectomy. Participants were randomly assigned in a 1:1 ratio to receive either postoperative ice packing or warm sitz baths for 7 days. Both groups received the same surgical technique, analgesic regimen, bowel management, and wound care protocol.
The primary outcome was the mean postoperative pain score during postoperative days 1 through 7. Secondary outcomes included perianal swelling, early wound status assessed using the REEDA scale, rescue analgesic use, and adverse events. The study aimed to determine whether ice packing provides better early postoperative recovery than warm sitz baths without increasing adverse events.
Read the detailed description
This prospective, two-center, parallel-group randomized controlled trial included eligible patients undergoing closed Ferguson hemorrhoidectomy at Istanbul Okan University Health Center and Uskudar University-Memorial Atasehir Hospital between September 2024 and April 2026. Participants were randomly assigned in a 1:1 ratio using a computer-generated allocation sequence.
Participants assigned to the ice-packing group received covered cold gel packs applied to the perianal region. During hospitalization, the packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued the application for 10 minutes every hour while awake for 7 days. Participants assigned to the warm sitz bath group used warm water sitz baths for 5 minutes, four times daily, for 7 days.
All participants underwent the same Ferguson hemorrhoidectomy technique and received a standardized postoperative analgesic regimen, bowel management protocol, and wound care instructions. Because of the nature of the interventions, participants and the clinical personnel providing treatment instructions could not be blinded. Outcome assessments were performed by surgeons who were not involved in administering the postoperative interventions, and the data analysts were blinded to treatment allocation.
The primary outcome was the mean pain score during postoperative days 1 through 7. Pain was evaluated using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included perianal swelling assessed on postoperative days 1, 3, and 7; early wound status assessed using the REEDA scale on postoperative day 7; rescue analgesic use; and adverse events. Participants were followed for 7 days after surgery.
- Conditions
- Hemorrhoids, Postoperative Pain
- Being tested
- Cryotherapy (Ice Packing), Warm Sitz Bath
- Keywords
- Ferguson Hemorrhoidectomy, Ice Packing, Cryotherapy, Warm Sitz Bath, Perianal Edema, Wound Healing, REEDA Scale
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy (Ice Packing)Other
Two 13 × 13 cm cold gel packs covered with disposable protective sleeves were folded into a U-shape and applied to the perianal region. During hospitalization, the packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued the application for 10 minutes every hour while awake for 7 days.
Warm Sitz BathOther
Participants used a standard plastic sitz bath filled with fresh warm water at approximately their usual showering temperature. Each application lasted 5 minutes and was performed four times daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Ice Packing | Experimental | Participants underwent standardized Ferguson hemorrhoidectomy and received postoperative ice packing applied to the perianal region. During hospitalization, covered cold gel packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued ice packing for 10 minutes every hour while awake for 7 days. Receives: Other: Cryotherapy (Ice Packing) |
| Warm Sitz Bath | Active comparator | Participants underwent standardized Ferguson hemorrhoidectomy and received postoperative warm sitz baths. Participants used a standard plastic sitz bath filled with warm water for 5 minutes, four times daily, for 7 days. Receives: Other: Warm Sitz Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative Pain Score During Postoperative Days 1-7
Pain was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Daily pain scores recorded during postoperative days 1 through 7 were averaged for each participant. Lower scores indicate less pain.
Measured: Postoperative days 1 through 7
Secondary outcomes (3)
Perianal Swelling Score
Perianal swelling was assessed using a four-grade clinical scale: grade 0, no swelling; grade 1, mild swelling; grade 2, moderate swelling; and grade 3, severe swelling. Lower scores indicate less swelling.
Measured: Postoperative days 1, 3, and 7
Early Wound Status Assessed Using the REEDA Scale
Early wound status was assessed using the REEDA scale, which evaluates redness, edema, ecchymosis, discharge, and approximation of the wound edges. Each component is scored from 0 to 3, producing a total score from 0 to 15. Lower scores indicate a more favorable wound status.
-
Measured: Postoperative day 7
Rescue Analgesic Use
Rescue analgesic use was assessed as the number and proportion of participants who required additional analgesic medication beyond the standardized postoperative analgesic regimen, together with the number of rescue analgesic doses used.
Measured: From surgery through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Sep 2024
- Primary completion1 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to two parallel postoperative care groups: ice packing or warm sitz baths.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Atasehir Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ferhat Ferhatoğlu, Memorial Atasehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843563
- Sponsor's protocol ID
- 37
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Sharing Statement: Individual participant data from this study will not be shared.
Publications
Seow-En I, Chen LRH, Zhao Y, Ng YY, Tan EK. Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids. Ann Coloproctol. 2025 Dec;41(6):537-544. doi: 10.3393/ac.2025.00549.0078. Epub 2025 Dec 24.
PubMed 41486911Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
PubMed 38294832
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ice Packing Versus Warm Sitz Baths After Ferguson Hemorrhoidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07843563
- Acronym / sponsor ID
- 37
- Conditions
- Hemorrhoids, Postoperative Pain
- Keywords
- Ferguson Hemorrhoidectomy, Ice Packing, Cryotherapy, Warm Sitz Bath, Perianal Edema, Wound Healing, REEDA Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Memorial Atasehir HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Warm sitz baths are commonly recommended after hemorrhoidectomy, although their benefit for early postoperative recovery remains uncertain. Local cold application may reduce postoperative pain and perianal swelling.
This prospective, two-center, randomized controlled trial compared ice packing with warm sitz baths in patients undergoing Ferguson hemorrhoidectomy. Participants were randomly assigned in a 1:1 ratio to receive either postoperative ice packing or warm sitz baths for 7 days. Both groups received the same surgical technique, analgesic regimen, bowel management, and wound care protocol.
The primary outcome was the mean postoperative pain score during postoperative days 1 through 7. Secondary outcomes included perianal swelling, early wound status assessed using the REEDA scale, rescue analgesic use, and adverse events. The study aimed to determine whether ice packing provides better early postoperative recovery than warm sitz baths without increasing adverse events.
Detailed description
This prospective, two-center, parallel-group randomized controlled trial included eligible patients undergoing closed Ferguson hemorrhoidectomy at Istanbul Okan University Health Center and Uskudar University-Memorial Atasehir Hospital between September 2024 and April 2026. Participants were randomly assigned in a 1:1 ratio using a computer-generated allocation sequence.
Participants assigned to the ice-packing group received covered cold gel packs applied to the perianal region. During hospitalization, the packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued the application for 10 minutes every hour while awake for 7 days. Participants assigned to the warm sitz bath group used warm water sitz baths for 5 minutes, four times daily, for 7 days.
All participants underwent the same Ferguson hemorrhoidectomy technique and received a standardized postoperative analgesic regimen, bowel management protocol, and wound care instructions. Because of the nature of the interventions, participants and the clinical personnel providing treatment instructions could not be blinded. Outcome assessments were performed by surgeons who were not involved in administering the postoperative interventions, and the data analysts were blinded to treatment allocation.
The primary outcome was the mean pain score during postoperative days 1 through 7. Pain was evaluated using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included perianal swelling assessed on postoperative days 1, 3, and 7; early wound status assessed using the REEDA scale on postoperative day 7; rescue analgesic use; and adverse events. Participants were followed for 7 days after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to two parallel postoperative care groups: ice packing or warm sitz baths.
| Arm | Type | Receives |
|---|---|---|
| Ice Packing | Experimental | Other: Cryotherapy (Ice Packing)Participants underwent standardized Ferguson hemorrhoidectomy and received postoperative ice packing applied to the perianal region. During hospitalization, covered cold gel packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued ice packing for 10 minutes every hour while awake for 7 days. |
| Warm Sitz Bath | Active comparator | Other: Warm Sitz BathParticipants underwent standardized Ferguson hemorrhoidectomy and received postoperative warm sitz baths. Participants used a standard plastic sitz bath filled with warm water for 5 minutes, four times daily, for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Primary hemorrhoidal disease requiring Ferguson hemorrhoidectomy.
- American Society of Anesthesiologists (ASA) physical status class I or II.
- Ability to understand the study instructions, provide written informed consent, and comply with the assigned postoperative intervention and follow-up schedule.
- -
Key exclusion criteria (9 listed)
- Recurrent hemorrhoidal disease.
- Concurrent anal pathology, including anal fistula, anal fissure, or anal polyp.
- History of chronic pain.
- Regular analgesic use.
- Cognitive impairment that could interfere with pain assessment or adherence to the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy (Ice Packing)Two 13 × 13 cm cold gel packs covered with disposable protective sleeves were folded into a U-shape and applied to the perianal region. During hospitalization, the packs were applied for 15 minutes every hour while the participant was awake. After discharge, participants continued the application for 10 minutes every hour while awake for 7 days. | Other | Ice Packing |
| Warm Sitz BathParticipants used a standard plastic sitz bath filled with fresh warm water at approximately their usual showering temperature. Each application lasted 5 minutes and was performed four times daily for 7 days. | Other | Warm Sitz Bath |
Primary outcome
Mean Postoperative Pain Score During Postoperative Days 1-7
Time frame: Postoperative days 1 through 7
Pain was assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Daily pain scores recorded during postoperative days 1 through 7 were averaged for each participant. Lower scores indicate less pain.
3 secondary outcomes
Perianal Swelling Score
Time frame: Postoperative days 1, 3, and 7
Early Wound Status Assessed Using the REEDA Scale
Time frame: Postoperative day 7
Rescue Analgesic Use
Time frame: From surgery through postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 41486911Seow-En I, Chen LRH, Zhao Y, Ng YY, Tan EK. Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids. Ann Coloproctol. 2025 Dec;41(6):537-544. doi: 10.3393/ac.2025.00549.0078. Epub 2025 Dec 24.
- Results publication: PubMed 38294832Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
- Individual participant dataSharing planned: No. Data Sharing Statement: Individual participant data from this study will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy (Ice Packing) and Warm Sitz Bath in people with Hemorrhoids and Postoperative Pain, run by Memorial Atasehir Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 9 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 28 Sep 2026. 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 Turkey (Türkiye). 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?
Mean Postoperative Pain Score During Postoperative Days 1-7 (time frame: Postoperative days 1 through 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07843563, which also lists 2 linked publications.
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 28 Sep 2026.