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Not yet recruitingNCT07196865Updated Mar 4, 2026

Comparison of the Clinical Effects of Open, Closed, and Semi-close Hemorrhoidectomy.

An interventional study of Open Hemorrhoidectomy and Closed Hemorrhoidectomy (Ferguson Technique) in Hemorrhoids, sponsored by The Affiliated Hospital of Putian University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by The Affiliated Hospital of Putian University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
378
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Hemorrhoids

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03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 378 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

The Affiliated Hospital of Putian University is the lead sponsor of 14 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients aged 18 to 75 years.
  2. Clinical diagnosis of mixed hemorrhoids requiring surgical intervention.
  3. Scheduled to undergo hemorrhoidectomy with ligation of internal hemorrhoids and excision of external hemorrhoids.
  4. Willing and able to provide written .

Exclusion criteria

Exclusion Criteria:

  1. History of mental illness or cognitive impairment that may affect the ability to provide or comply with the study protocol.
  2. Diagnosis of diabetes mellitus.
  3. Planned concomitant procedures (e.g., radiofrequency ablation, sclerotherapy) in addition to hemorrhoidectomy.
  4. Inability or unwillingness to comply with scheduled follow-up visits.
  5. 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
378 participants (estimated)

Study arms

  • Experimental
    Open Hemorrhoidectomy Group

    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.

    Procedure: Open Hemorrhoidectomy

  • Experimental
    Closed Hemorrhoidectomy Group

    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.

    Procedure: Closed Hemorrhoidectomy (Ferguson Technique)

  • Experimental
    Semi-Closed Hemorrhoidectomy Group

    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.

    Procedure: Semi-Closed Hemorrhoidectomy

Interventions

  • ProcedureOpen Hemorrhoidectomy

    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.

  • ProcedureClosed 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.

  • ProcedureSemi-Closed Hemorrhoidectomy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Daily from postoperative Day 1 until complete epithelialization is achieved (assessed for up to 28 days post-surgery)

Secondary outcomes

  1. 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).

    Time frame: Baseline (preoperative), and on postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).

  2. Perianal edema severity

    Severity of swelling around the surgical site evaluated by trained research nurses using a standardized 0-6 point scale.

    Time frame: Postoperative days 1, 2, 3, 5, 7, and 14 (±2 days).

  3. Length of hospital stay

    Duration of hospitalization measured in hours from the end of surgery to discharge, using standardized discharge criteria.

    Time frame: From end of surgery until discharge (assessed up to 7 days postoperatively).

  4. Complication incidence

    Occurrence of postoperative complications (e.g., infection, bleeding, urinary retention) classified and graded using the Clavien-Dindo system.

    Time frame: Within 30 days after surgery.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.

Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 8 months is below that.

Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2025
First posted
Sep 29, 2025
StartEst.
Apr 1, 2026
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 30, 2026
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07196865
Lead sponsor
The Affiliated Hospital of Putian University
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Apr 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Mar 4, 2026

Study contacts

Chenxing Jian C Chen, doctoral
Contact
ptyyjcx@126.com
86-139559538950

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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