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Not yet recruitingNCT07495046LEHSUpdated Mar 27, 2026

Low Excision and High Suspension Hemorrhoidectomy Versus Conventional Milligan-Morgan Hemorrhoidectomy for Grade III-IV Mixed Hemorrhoids

An interventional study of Low Excision and High Suspension Hemorrhoidectomy and Conventional Milligan-Morgan Hemorrhoidectomy in Mixed Hemorrhoids, sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

Low Excision and High Suspension Hemorrhoidectomy versus Conventional Milligan-Morgan Hemorrhoidectomy for Mixed Hemorrhoids

Read the detailed description
  1. 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.

  2. 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.
  3. 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.

  4. 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

  5. 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.
  6. 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%.
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Conditions studied

  • Mixed Hemorrhoids

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Keywords

  • Mixed Hemorrhoids
  • low excision and high suspension hemorrhoidectomy
  • Milligan-Morgan hemorrhoidectomy;
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 120 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:• Age 18-70 years, male or female;

  • 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 ;

  • 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.
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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

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

Study arms

  • Experimental
    Study Group

    Low Excision and High Suspension Hemorrhoidectomy

    Procedure: Low Excision and High Suspension Hemorrhoidectomy

  • Active comparator
    control Group

    Conventional Milligan-Morgan Hemorrhoidectomy

    Procedure: Conventional Milligan-Morgan Hemorrhoidectomy

Interventions

  • ProcedureLow Excision and High Suspension Hemorrhoidectomy

    Low Excision and High Suspension Hemorrhoidectomy

  • ProcedureConventional Milligan-Morgan Hemorrhoidectomy

    Conventional Milligan-Morgan Hemorrhoidectomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks postoperatively

  2. 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.

    Time frame: 12 months postoperatively

07

Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 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
NCT07495046
Lead sponsor
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Responsible party
Heng Deng (Chief Physician, Principal Investigator, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine) — Principal investigator
First posted
Mar 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Mar 27, 2026

Oversight

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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