NCT07495046

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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%.

Conditions

• Mixed Hemorrhoids

Interventions

Type	Name	Description
PROCEDURE	Low Excision and High Suspension Hemorrhoidectomy	Low Excision and High Suspension Hemorrhoidectomy
PROCEDURE	Conventional Milligan-Morgan Hemorrhoidectomy	Conventional Milligan-Morgan Hemorrhoidectomy

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2026-03-27
• Last updated: 2026-03-27