Mixed HemorrhoidsLEHSNCT07495046
Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids
A study testing Low Excision and High Suspension Hemorrhoidectomy and Conventional Milligan-Morgan Hemorrhoidectomy in people with Mixed Hemorrhoids, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Trial summary
Low Excision and High Suspension Hemorrhoidectomy versus Conventional Milligan-Morgan Hemorrhoidectomy for Mixed Hemorrhoids Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mixed Hemorrhoids
- What is being tested?
- Low Excision and High Suspension Hemorrhoidectomy and Conventional Milligan-Morgan Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Goligher grade III-IV mixed hemorrhoids via anorectal examination;
- Failed conservative treatment for at least 3 months;
- Voluntarily participated in the study and agreed to complete the 12-month follow-up.
- Exclusion Criteria:• Combined with acute perianal abscess, anal fistula, anal fissure, inflammatory bowel disease, rectal prolapse, or anorectal malignancy;
- History of previous anorectal surgery;
- Severe coagulation dysfunction, cardiopulmonary insufficiency, hepatic/renal failure, or mental disorders;
- Pregnancy or lactation;
- Inability to cooperate with postoperative follow-up and evaluation.
Who cannot join
None listed.
About this study
Official title: Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Patients With Goligher Grade III-IV Mixed Hemorrhoids
Low Excision and High Suspension Hemorrhoidectomy versus Conventional Milligan-Morgan Hemorrhoidectomy for Mixed Hemorrhoids
Read the detailed description
- Participants Inclusion Criteria Age 18 to 70 years of age, both male and female; diagnosed with Goligher grade III or IV mixed hemorrhoids by anorectal physical examination; failure of conservative treatment for at least 3 months; voluntary participation in the study and written informed consent to complete the 12-month follow-up. Exclusion Criteria Complicated with acute perianal abscess, anal fistula, anal fissure, inflammatory bowel disease, rectal prolapse, or anorectal malignancy; history of previous anorectal surgery; severe coagulation dysfunction, cardiopulmonary insufficiency, hepatic or renal failure, or mental disorders; pregnant or lactating women; inability to cooperate with postoperative follow-up and clinical evaluation.
- Randomization and Blinding A 1:1 individual randomization was used with block randomization (block size=4) via a computer-generated random number table. Allocation concealment was implemented using sealed, opaque envelopes opened only on the day of surgery. Outcome assessors (responsible for pain scoring, complication recording, anorectal manometry) and statistical analysts were blinded to the group assignments to minimize detection bias and analysis bias.
- Surgical Procedures Experimental Intervention: Low Excision and High Suspension Hemorrhoidectomy (LEHS) All procedures were performed under spinal or epidural anesthesia with patients in the lithotomy position by senior anorectal surgeons with at least 10 years of clinical experience. The intervention included four key steps: minimal excision of external hemorrhoidal tissue along the natural perianal skin crease with preservation of sufficient skin bridges and sensory tissue; full mobilization of internal hemorrhoidal mass from the rectal submucosal tissue to expose the intact base of the hemorrhoid pedicle; high figure-of-eight ligation of the pedicle base with 3-0 absorbable sutures followed by suspension and fixation of the ligated pedicle to the upper rectal wall for anal cushion anatomical restoration; partial closure of surgical wounds with absorbable sutures while maintaining adequate drainage to prevent hematoma and infection. Comparator Intervention: Conventional Milligan-Morgan (MM) Hemorrhoidectomy The procedure was performed under the same anesthesia and position by the same surgical team as the LEHS group. Key steps included conventional V-shaped incision from the perianal skin to the dentate line with wide dissection and resection of external hemorrhoidal tissue; direct ligation of the internal hemorrhoid base with 3-0 silk sutures without prior mobilization or dissection, followed by radical resection of the distal hemorrhoidal tissue; preservation of skin bridges of at least 0.5 cm and natural open drainage for all surgical wounds without suture closure.
- Outcome Measures 4.1 Primary Outcomes （1）Clinical effective rate of mixed hemorrhoids Description: Cured (complete resolution of clinical symptoms and hemorrhoid prolapse) plus improved (obvious relief of clinical symptoms) divided by the total number of patients; a clinical effective rate of at least 90% was defined as effective. Time Frame: 12 weeks postoperatively （2）Hemorrhoid recurrence rate Description: Recurrence was defined as the reappearance of hemorrhoid prolapse or rectal bleeding that required clinical reintervention during the follow-up period. Time Frame: 12 months postoperatively 4.2 Secondary Outcomes （1）Perioperative indicators Description: Assessment of operative time (minutes) and intraoperative blood loss (milliliters) during the surgical procedure. Time Frame: Perioperatively （2） Postoperative pain score Description: Visual Analogue Scale (VAS, 0-10 points) to evaluate the degree of postoperative pain, with higher scores indicating more severe pain. Time Frame: 6 hours postoperatively; 24 hours postoperatively; 72 hours postoperatively; 7 days postoperatively; 14 days postoperatively 4.3 Postoperative recovery parameters Description: Assessment of time to first defecation, wound healing time (days), and length of hospital stay (days) after surgery. Time Frame: Up to 14 days postoperatively 4. 4 Postoperative complication rate Description: Recording of adverse events including perianal edema, urinary retention, secondary bleeding, wound infection, anal stenosis, and anal discomfort. Time Frame: Up to 12 months postoperatively 4.5 Anorectal manometry parameters Description: Measurement of anal resting pressure (ARP), anal maximum squeeze pressure (AMSP), and rectal sensation threshold (RST) by anorectal manometry. Time Frame: Baseline; 12 weeks postoperatively 4.6 Patient satisfaction score Description: 0-10 point subjective satisfaction score assessed by clinical questionnaire, with higher scores indicating higher patient satisfaction. Time Frame: 12 months postoperatively
- Follow-Up All enrolled patients were scheduled for follow-up at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months postoperatively. Clinical physical examinations, symptom assessments, and postoperative complication recordings were conducted at each follow-up visit; anorectal manometry was re-measured at 12 weeks postoperatively, and hemorrhoid recurrence was comprehensively evaluated at the 12-month final follow-up.
- Statistical Analysis Continuous data were expressed as mean plus or minus standard deviation (normal distribution) or median (interquartile range) (non-normal distribution), and compared using independent-samples t-test or Mann-Whitney U test, respectively. Categorical data were expressed as number (percentage) and compared using Chi-square test or Fisher's exact test. A two-sided P value less than 0.05 was considered statistically significant. A non-inferiority margin of -10% was set for the primary clinical effective rate outcome; non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) of the effective rate difference between the two groups was higher than -10%.
- Conditions
- Mixed Hemorrhoids
- Being tested
- Low Excision and High Suspension Hemorrhoidectomy, Conventional Milligan-Morgan Hemorrhoidectomy
- Keywords
- Mixed Hemorrhoids, low excision and high suspension hemorrhoidectomy, Milligan-Morgan hemorrhoidectomy;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Excision and High Suspension HemorrhoidectomyProcedure or surgery
Low Excision and High Suspension Hemorrhoidectomy
Conventional Milligan-Morgan HemorrhoidectomyProcedure or surgery
Conventional Milligan-Morgan Hemorrhoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Low Excision and High Suspension Hemorrhoidectomy Receives: Procedure: Low Excision and High Suspension Hemorrhoidectomy |
| control Group | Active comparator | Conventional Milligan-Morgan Hemorrhoidectomy Receives: Procedure: Conventional Milligan-Morgan Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effective rate at 12 weeks postoperatively
Cured (complete resolution of symptoms and hemorrhoid prolapse) + improved (obvious relief of clinical symptoms) / total number of patients; an effective rate ≥90% was defined as clinically effective.
Measured: 12 weeks postoperatively
Hemorrhoid recurrence rate at 12 months postoperatively
Recurrence was defined as the reappearance of hemorrhoid prolapse or rectal bleeding requiring clinical reintervention during the follow-up period.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed 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
- Patients were randomly assigned 1:1 to the LEHS group or MM group using a computer-generated random number table with block randomization (block size=4). Allocation concealment was achieved using sealed, opaque envelopes, which were opened only on the day of surgery. Outcome assessors (responsible for pain scoring, complication recording, and manometry testing) and statistical analysts were blinded to group assignments to minimize bias.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495046
- Sponsor's protocol ID
- HF-2024-KY-036
- Other IDs
- 202427b10020009
- Acronym
- LEHS
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shu Y, Deng H, Zhu J, Zhang C, Sun P, Wang F, Liu H. Low excision and high suspension hemorrhoidectomy versus conventional Milligan-Morgan hemorrhoidectomy for mixed hemorrhoids: a 12-month prospective randomized controlled trial. BMC Surg. 2026 Jul 2. doi: 10.1186/s12893-026-04006-8. Online ahead of print.
PubMed 42393699
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Patients With Goligher Grade III-IV Mixed Hemorrhoids
- ClinicalTrials.gov ID
- NCT07495046
- Acronym / sponsor ID
- LEHS / HF-2024-KY-036
- Conditions
- Mixed Hemorrhoids
- Keywords
- Mixed Hemorrhoids, low excision and high suspension hemorrhoidectomy, Milligan-Morgan hemorrhoidectomy;
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Mar 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.
Low Excision and High Suspension Hemorrhoidectomy versus Conventional Milligan-Morgan Hemorrhoidectomy for Mixed Hemorrhoids
Detailed description
- Participants Inclusion Criteria Age 18 to 70 years of age, both male and female; diagnosed with Goligher grade III or IV mixed hemorrhoids by anorectal physical examination; failure of conservative treatment for at least 3 months; voluntary participation in the study and written informed consent to complete the 12-month follow-up. Exclusion Criteria Complicated with acute perianal abscess, anal fistula, anal fissure, inflammatory bowel disease, rectal prolapse, or anorectal malignancy; history of previous anorectal surgery; severe coagulation dysfunction, cardiopulmonary insufficiency, hepatic or renal failure, or mental disorders; pregnant or lactating women; inability to cooperate with postoperative follow-up and clinical evaluation.
- Randomization and Blinding A 1:1 individual randomization was used with block randomization (block size=4) via a computer-generated random number table. Allocation concealment was implemented using sealed, opaque envelopes opened only on the day of surgery. Outcome assessors (responsible for pain scoring, complication recording, anorectal manometry) and statistical analysts were blinded to the group assignments to minimize detection bias and analysis bias.
- Surgical Procedures Experimental Intervention: Low Excision and High Suspension Hemorrhoidectomy (LEHS) All procedures were performed under spinal or epidural anesthesia with patients in the lithotomy position by senior anorectal surgeons with at least 10 years of clinical experience. The intervention included four key steps: minimal excision of external hemorrhoidal tissue along the natural perianal skin crease with preservation of sufficient skin bridges and sensory tissue; full mobilization of internal hemorrhoidal mass from the rectal submucosal tissue to expose the intact base of the hemorrhoid pedicle; high figure-of-eight ligation of the pedicle base with 3-0 absorbable sutures followed by suspension and fixation of the ligated pedicle to the upper rectal wall for anal cushion anatomical restoration; partial closure of surgical wounds with absorbable sutures while maintaining adequate drainage to prevent hematoma and infection. Comparator Intervention: Conventional Milligan-Morgan (MM) Hemorrhoidectomy The procedure was performed under the same anesthesia and position by the same surgical team as the LEHS group. Key steps included conventional V-shaped incision from the perianal skin to the dentate line with wide dissection and resection of external hemorrhoidal tissue; direct ligation of the internal hemorrhoid base with 3-0 silk sutures without prior mobilization or dissection, followed by radical resection of the distal hemorrhoidal tissue; preservation of skin bridges of at least 0.5 cm and natural open drainage for all surgical wounds without suture closure.
- Outcome Measures 4.1 Primary Outcomes （1）Clinical effective rate of mixed hemorrhoids Description: Cured (complete resolution of clinical symptoms and hemorrhoid prolapse) plus improved (obvious relief of clinical symptoms) divided by the total number of patients; a clinical effective rate of at least 90% was defined as effective. Time Frame: 12 weeks postoperatively （2）Hemorrhoid recurrence rate Description: Recurrence was defined as the reappearance of hemorrhoid prolapse or rectal bleeding that required clinical reintervention during the follow-up period. Time Frame: 12 months postoperatively 4.2 Secondary Outcomes （1）Perioperative indicators Description: Assessment of operative time (minutes) and intraoperative blood loss (milliliters) during the surgical procedure. Time Frame: Perioperatively （2） Postoperative pain score Description: Visual Analogue Scale (VAS, 0-10 points) to evaluate the degree of postoperative pain, with higher scores indicating more severe pain. Time Frame: 6 hours postoperatively; 24 hours postoperatively; 72 hours postoperatively; 7 days postoperatively; 14 days postoperatively 4.3 Postoperative recovery parameters Description: Assessment of time to first defecation, wound healing time (days), and length of hospital stay (days) after surgery. Time Frame: Up to 14 days postoperatively 4. 4 Postoperative complication rate Description: Recording of adverse events including perianal edema, urinary retention, secondary bleeding, wound infection, anal stenosis, and anal discomfort. Time Frame: Up to 12 months postoperatively 4.5 Anorectal manometry parameters Description: Measurement of anal resting pressure (ARP), anal maximum squeeze pressure (AMSP), and rectal sensation threshold (RST) by anorectal manometry. Time Frame: Baseline; 12 weeks postoperatively 4.6 Patient satisfaction score Description: 0-10 point subjective satisfaction score assessed by clinical questionnaire, with higher scores indicating higher patient satisfaction. Time Frame: 12 months postoperatively
- Follow-Up All enrolled patients were scheduled for follow-up at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months postoperatively. Clinical physical examinations, symptom assessments, and postoperative complication recordings were conducted at each follow-up visit; anorectal manometry was re-measured at 12 weeks postoperatively, and hemorrhoid recurrence was comprehensively evaluated at the 12-month final follow-up.
- Statistical Analysis Continuous data were expressed as mean plus or minus standard deviation (normal distribution) or median (interquartile range) (non-normal distribution), and compared using independent-samples t-test or Mann-Whitney U test, respectively. Categorical data were expressed as number (percentage) and compared using Chi-square test or Fisher's exact test. A two-sided P value less than 0.05 was considered statistically significant. A non-inferiority margin of -10% was set for the primary clinical effective rate outcome; non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) of the effective rate difference between the two groups was higher than -10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly assigned 1:1 to the LEHS group or MM group using a computer-generated random number table with block randomization (block size=4). Allocation concealment was achieved using sealed, opaque envelopes, which were opened only on the day of surgery. Outcome assessors (responsible for pain scoring, complication recording, and manometry testing) and statistical analysts were blinded to group assignments to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Low Excision and High Suspension HemorrhoidectomyLow Excision and High Suspension Hemorrhoidectomy |
| control Group | Active comparator | Procedure: Conventional Milligan-Morgan HemorrhoidectomyConventional Milligan-Morgan Hemorrhoidectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with Goligher grade III-IV mixed hemorrhoids via anorectal examination;
- Failed conservative treatment for at least 3 months;
- Voluntarily participated in the study and agreed to complete the 12-month follow-up.
- Exclusion Criteria:• Combined with acute perianal abscess, anal fistula, anal fissure, inflammatory bowel disease, rectal prolapse, or anorectal malignancy;
- History of previous anorectal surgery;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low Excision and High Suspension HemorrhoidectomyLow Excision and High Suspension Hemorrhoidectomy | Procedure or surgery | Study Group |
| Conventional Milligan-Morgan HemorrhoidectomyConventional Milligan-Morgan Hemorrhoidectomy | Procedure or surgery | control Group |
Primary outcome
Clinical effective rate at 12 weeks postoperatively
Time frame: 12 weeks postoperatively
Cured (complete resolution of symptoms and hemorrhoid prolapse) + improved (obvious relief of clinical symptoms) / total number of patients; an effective rate ≥90% was defined as clinically effective.
Hemorrhoid recurrence rate at 12 months postoperatively
Time frame: 12 months postoperatively
Recurrence was defined as the reappearance of hemorrhoid prolapse or rectal bleeding requiring clinical reintervention during the follow-up period.
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 27 Mar 2026.
- Derived from this study: PubMed 42393699Shu Y, Deng H, Zhu J, Zhang C, Sun P, Wang F, Liu H. Low excision and high suspension hemorrhoidectomy versus conventional Milligan-Morgan hemorrhoidectomy for mixed hemorrhoids: a 12-month prospective randomized controlled trial. BMC Surg. 2026 Jul 2. doi: 10.1186/s12893-026-04006-8. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low Excision and High Suspension Hemorrhoidectomy and Conventional Milligan-Morgan Hemorrhoidectomy in people with Mixed Hemorrhoids, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
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 8 inclusion and 0 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 27 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?
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?
Clinical effective rate at 12 weeks postoperatively (time frame: 12 weeks postoperatively). The study lists 2 primary outcomes in all. 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 NCT07495046, which also lists 1 linked publication.
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 27 Mar 2026.