HemorrhoidsNCT07196865
Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy.
A study testing Open Hemorrhoidectomy, Closed Hemorrhoidectomy (Ferguson Technique) and Semi-Closed Hemorrhoidectomy in people with Hemorrhoids, run by The Affiliated Hospital of Putian University.
Trial summary
This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (semi-closed). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Open Hemorrhoidectomy, Closed Hemorrhoidectomy (Ferguson Technique) and Semi-Closed Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years.
- Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
- Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
- Willing and able to provide written informed consent.
Who cannot join
- History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.
- Diagnosis of diabetes mellitus.
- Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
- Inability or unwillingness to comply with scheduled follow-up visits.
- Presence of severe perioperative comorbidities that render the patient unsuitable for the planned surgical protocol or anesthesia (as determined by the attending anesthesiologist or surgeon).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy: Study Protocol for a Single-center, Prospective, Open-label and Randomized Clinical Trial.
This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (semi-closed). The goal is to see which method leads to faster healing, less pain, fewer complications, and better long-term results. Patients undergoing hemorrhoidectomy will be randomly assigned to one of the three groups. All patients will receive standard post-operative care. Researchers will measure healing time, pain levels, need for pain medication, hospital stay, complications, and check if hemorrhoids come back within one year.
Read the detailed description
Hemorrhoids are a very common condition, and when surgery is needed, there is no consensus on the best way to manage the surgical wound afterward. This single-center, prospective, randomized clinical trial aims to directly compare the clinical outcomes of the three primary wound management techniques: open, closed, and semi-closed hemorrhoidectomy.
A total of 378 patients will be randomly assigned to one of the three treatment groups. The primary focus is on comparing key short-term outcomes, including the time it takes for the wound to fully heal, the length of the hospital stay, and the rate of complications such as surgical site infection, bleeding, and urinary retention.
Secondary outcomes will provide a broader picture of patient recovery. Pain will be carefully assessed using a standardized pain scale (Visual Analog Scale) on multiple days after surgery and by tracking the total amount of pain medication required during hospitalization. Furthermore, to understand the long-term effectiveness of each technique, the study will follow patients for one year after surgery to assess their quality of life and monitor for any recurrence of hemorrhoids.
This is the first clinical trial to evaluate all three techniques within the same study. The results are expected to provide high-quality evidence to help surgeons choose the most effective wound management strategy, ultimately improving patient care and recovery after hemorrhoid surgery.
- Conditions
- Hemorrhoids
- Being tested
- Open Hemorrhoidectomy, Closed Hemorrhoidectomy (Ferguson Technique), Semi-Closed Hemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open HemorrhoidectomyProcedure or surgery
Patients in this group undergo a hemorrhoidectomy procedure where, after external stripping and internal ligation, the surgical wound is left entirely open without sutures to heal by secondary intention. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.
Closed Hemorrhoidectomy (Ferguson Technique)Procedure or surgery
Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the entire surgical wound is closed primarily using interrupted non-absorbable sutures. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.
Semi-Closed HemorrhoidectomyProcedure or surgery
Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the distal half of the incision (away from the anal canal) is closed with interrupted sutures, while the proximal half remains open. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection.
| Study group | Role | What they receive |
|---|---|---|
| Open Hemorrhoidectomy Group | Experimental | Patients in this group will undergo open hemorrhoidectomy. Following external stripping and internal ligation, the wound will be left open without any sutures for healing by secondary intention. Receives: Procedure: Open Hemorrhoidectomy |
| Closed Hemorrhoidectomy Group | Experimental | Patients in this group will undergo closed hemorrhoidectomy (Ferguson technique). After achieving hemostasis, the entire wound will be closed primarily using interrupted non-absorbable sutures. Receives: Procedure: Closed Hemorrhoidectomy (Ferguson Technique) |
| Semi-Closed Hemorrhoidectomy Group | Experimental | Patients in this group will undergo semi-closed hemorrhoidectomy. Following hemostasis, the distal half of the incision (away from the anal canal) will be closed with interrupted sutures, while the proximal half is left open. Receives: Procedure: Semi-Closed Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
The time required for complete wound healing, defined as 100% re-epithelialization of the surgical site with no exudate or scab, assessed by a blinded evaluator.
Measured: Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)
Secondary outcomes (4)
Postoperative pain intensity (NRS score)
Pain intensity was evaluated on a 0 to 10 Numerical Rating Scale (NRS), with higher scores indicating more severe pain (0 = no pain; 10 = worst possible pain).
Measured: Baseline (preoperative), and on postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
Perianal edema severity
Severity of swelling around the surgical site evaluated by trained research nurses using a standardized 0-6 point scale.
Measured: Postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
Length of hospital stay
Duration of hospitalization measured in hours from the end of surgery to discharge, using standardized discharge criteria.
Measured: From end of surgery until discharge (assessed up to 7 days postoperatively).
Complication incidence
Occurrence of postoperative complications (e.g., infection, bleeding, urinary retention) classified and graded using the Clavien-Dindo system.
Measured: Within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm, parallel-group, randomized controlled trial (RCT). Participants are randomly allocated in a 1:1:1 ratio to one of three distinct intervention groups, where they receive only that specific surgical intervention and are followed concurrently throughout the study period. The groups are defined by the wound management technique used after hemorrhoidectomy: Group 1 (Open): Wound left unsutured. Group 2 (Closed):Wound fully closed with interrupted non-absorbable sutures. Group 3 (Semi-Closed): Distal half of the incision closed with interrupted sutures.
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196865
- Sponsor's protocol ID
- AHPutianU 2025918
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy: Study Protocol for a Single-center, Prospective, Open-label and Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07196865
- Acronym / sponsor ID
- AHPutianU 2025918
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
This study compares three different ways surgeons close the wound after removing hemorrhoids (piles): leaving it completely open, stitching it completely closed, or stitching only half of it closed (semi-closed). The goal is to see which method leads to faster healing, less pain, fewer complications, and better long-term results. Patients undergoing hemorrhoidectomy will be randomly assigned to one of the three groups. All patients will receive standard post-operative care. Researchers will measure healing time, pain levels, need for pain medication, hospital stay, complications, and check if hemorrhoids come back within one year.
Detailed description
Hemorrhoids are a very common condition, and when surgery is needed, there is no consensus on the best way to manage the surgical wound afterward. This single-center, prospective, randomized clinical trial aims to directly compare the clinical outcomes of the three primary wound management techniques: open, closed, and semi-closed hemorrhoidectomy.
A total of 378 patients will be randomly assigned to one of the three treatment groups. The primary focus is on comparing key short-term outcomes, including the time it takes for the wound to fully heal, the length of the hospital stay, and the rate of complications such as surgical site infection, bleeding, and urinary retention.
Secondary outcomes will provide a broader picture of patient recovery. Pain will be carefully assessed using a standardized pain scale (Visual Analog Scale) on multiple days after surgery and by tracking the total amount of pain medication required during hospitalization. Furthermore, to understand the long-term effectiveness of each technique, the study will follow patients for one year after surgery to assess their quality of life and monitor for any recurrence of hemorrhoids.
This is the first clinical trial to evaluate all three techniques within the same study. The results are expected to provide high-quality evidence to help surgeons choose the most effective wound management strategy, ultimately improving patient care and recovery after hemorrhoid surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm, parallel-group, randomized controlled trial (RCT). Participants are randomly allocated in a 1:1:1 ratio to one of three distinct intervention groups, where they receive only that specific surgical intervention and are followed concurrently throughout the study period. The groups are defined by the wound management technique used after hemorrhoidectomy: Group 1 (Open): Wound left unsutured. Group 2 (Closed):Wound fully closed with interrupted non-absorbable sutures. Group 3 (Semi-Closed): Distal half of the incision closed with interrupted sutures.
| Arm | Type | Receives |
|---|---|---|
| Open Hemorrhoidectomy Group | Experimental | Procedure: Open HemorrhoidectomyPatients in this group will undergo open hemorrhoidectomy. Following external stripping and internal ligation, the wound will be left open without any sutures for healing by secondary intention. |
| Closed Hemorrhoidectomy Group | Experimental | Procedure: Closed Hemorrhoidectomy (Ferguson Technique)Patients in this group will undergo closed hemorrhoidectomy (Ferguson technique). After achieving hemostasis, the entire wound will be closed primarily using interrupted non-absorbable sutures. |
| Semi-Closed Hemorrhoidectomy Group | Experimental | Procedure: Semi-Closed HemorrhoidectomyPatients in this group will undergo semi-closed hemorrhoidectomy. Following hemostasis, the distal half of the incision (away from the anal canal) will be closed with interrupted sutures, while the proximal half is left open. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 75 years.
- Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
- Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- History of mental illness or cognitive impairment that may affect the ability to provide informed consent or comply with the study protocol.
- Diagnosis of diabetes mellitus.
- Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
- Inability or unwillingness to comply with scheduled follow-up visits.
- Presence of severe perioperative comorbidities that render the patient unsuitable for the planned surgical protocol or anesthesia (as determined by the attending anesthesiologist or surgeon).
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 |
|---|---|---|
| Open HemorrhoidectomyPatients in this group undergo a hemorrhoidectomy procedure where, after external stripping and internal ligation, the surgical wound is left entirely open without sutures to heal by secondary intention. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection. | Procedure or surgery | Open Hemorrhoidectomy Group |
| Closed Hemorrhoidectomy (Ferguson Technique)Patients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the entire surgical wound is closed primarily using interrupted non-absorbable sutures. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection. | Procedure or surgery | Closed Hemorrhoidectomy Group |
| Semi-Closed HemorrhoidectomyPatients in this group undergo a hemorrhoidectomy procedure where, after achieving hemostasis, the distal half of the incision (away from the anal canal) is closed with interrupted sutures, while the proximal half remains open. All patients receive standard postoperative care including potassium permanganate rinses and povidone-iodine disinfection. | Procedure or surgery | Semi-Closed Hemorrhoidectomy Group |
Primary outcome
Wound healing time
Time frame: Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)
The time required for complete wound healing, defined as 100% re-epithelialization of the surgical site with no exudate or scab, assessed by a blinded evaluator.
4 secondary outcomes
Postoperative pain intensity (NRS score)
Time frame: Baseline (preoperative), and on postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
Perianal edema severity
Time frame: Postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).
Length of hospital stay
Time frame: From end of surgery until discharge (assessed up to 7 days postoperatively).
Complication incidence
Time frame: Within 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Open Hemorrhoidectomy, Closed Hemorrhoidectomy (Ferguson Technique) and Semi-Closed Hemorrhoidectomy in people with Hemorrhoids, run by The Affiliated Hospital of Putian University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxing Jian C Chen, doctoral (86-139559538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)). 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 4 Mar 2026.