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RecruitingNCT07824999Updated Sep 17, 2026

Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids

An interventional study of Energy-based sutureless hemorrhoidectomy and Conventional Milligan-Morgan hemorrhoidectomy in Hemorrhoids, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Hemorrhoidal disease is a frequent benign anorectal ailment in surgical practice. Conventional excisional hemorrhoidectomy using the Milligan-Morgan technique remains effective but is significantly limited by severe postoperative pain and related complications. Sutureless hemorrhoidectomy utilizing energy-based vessel sealing devices (such as LigaSure or Harmonic Scalpel) aims to minimize tissue trauma, blood loss, and postoperative discomfort. This prospective comparative randomized clinical trial aims to evaluate and compare the perioperative and postoperative outcomes of sutureless hemorrhoidectomy versus conventional ligation hemorrhoidectomy in adult patients with advanced (grades III and IV) hemorrhoidal disease.

Read the detailed description

Symptomatic advanced hemorrhoids (grades III-IV) frequently require excisional surgical intervention. Traditional ligation techniques involve pedicle transfixion that often exacerbates postoperative pain, anal spasms, and urinary retention. Energy-based vessel sealing systems provide reliable pedicle occlusion without conventional transfixion or suture ligation, potentially expediting operative time and recovery. In this prospective randomized study conducted at the Department of General Surgery, Sohag University Hospital, 50 eligible adult patients with symptomatic grade III-IV hemorrhoidal disease will be randomly allocated (1:1) into two equal groups: Group A (n=25): Sutureless hemorrhoidectomy using an energy-based vessel sealing device. Group B (n=25): Conventional ligation hemorrhoidectomy using the standard Milligan-Morgan technique. Postoperatively, patients receive standardized analgesia and care, with systematic follow-up at 1 week, 2 weeks, 1 month, 3 months, and 6 months to evaluate pain scores, bleeding, wound healing, complication rates, return to normal activity, and symptom recurrence.

02

Conditions studied

  • Hemorrhoids

Keywords

  • Sutureless hemorrhoidectomy
  • LigaSure
  • Harmonic Scalpel
  • Milligan-Morgan
  • Postoperative pain
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 50 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
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

  • Adult patients aged 18 years or older.
  • Patients with symptomatic grade III or grade IV hemorrhoidal disease.
  • Combined internal and external hemorrhoidal disease requiring excisional hemorrhoidectomy.
  • Recurrent bleeding, prolapse, pain, mucous discharge, or hygiene difficulty despite conservative or office-based treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years.
  • Grade I or grade II hemorrhoids suitable for conservative or office-based therapy.
  • Acute thrombosed external hemorrhoids requiring emergency management.
  • Associated anal fissure, fistula-in-ano, perianal abscess, or inflammatory bowel disease.
  • Suspected or confirmed colorectal [cite: 1].
  • History of previous anorectal surgery[cite: 1].
  • Bleeding diathesis, uncontrolled anticoagulant therapy, or severe coagulopathy[cite: 1].
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.

05

Study design

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

Study arms

  • Active comparator
    Conventional Ligation Hemorrhoidectomy Group

    Patients undergoing conventional excisional hemorrhoidectomy using the Milligan-Morgan technique with suture ligation of the vascular pedicle.

    Procedure: Conventional Milligan-Morgan hemorrhoidectomy

  • Experimental
    Sutureless Hemorrhoidectomy Group

    Patients undergoing sutureless excisional hemorrhoidectomy using an energy-based vessel sealing device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation.

    Procedure: Energy-based sutureless hemorrhoidectomy

Interventions

  • ProcedureEnergy-based sutureless hemorrhoidectomy

    Excision of hemorrhoidal columns with vessel pedicle sealing using an energy-based device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation.

  • ProcedureConventional Milligan-Morgan hemorrhoidectomy

    Standard Milligan-Morgan hemorrhoidectomy with surgical dissection of hemorrhoidal columns and absorbable suture transfixion and ligation of vascular pedicles.

06

What researchers measure

Primary outcomes

  1. Postoperative Pain Score

    Assessed using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst imaginable pain) at fixed postoperative intervals.

    Time frame: Up to 6 months post-surgery

  2. Incidence of Postoperative Bleeding

    Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission.

    Time frame: Up to 6 months post-surgery

Secondary outcomes

  1. Operative Time

    Duration in minutes from the initiation of tissue excision to complete surgical hemostasis.

    Time frame: Intraoperative (at time of surgery)

  2. Intraoperative Blood Loss

    Estimated intraoperative blood loss measured in milliliters.

    Time frame: Intraoperative (at time of surgery)

  3. Total Postoperative Analgesic Requirement

    Total analgesic dosage, type, and duration required for postoperative pain management.

    Time frame: Up to 6 months post-surgery

  4. Time to Complete Wound Healing

    Clinical assessment of complete re-epithelialization of the anal wounds documented in weeks/months.

    Time frame: Assessed at 1 week, 2 weeks, 1 month, 3 months, and 6 months

  5. Length of Hospital Stay

    Duration of postoperative stay in hours/days from operation until fulfilling discharge criteria.

    Time frame: From surgical admission up to discharge (average 1-2 days)

  6. Time to Return to Normal Activity

    Recorded in days from surgery until the patient comfortably resumes routine daily non-strenuous activities.

    Time frame: Up to 6 months post-surgery

  7. Rate of Postoperative Complications and Recurrence

    Incidence of urinary retention, wound infection, anal stenosis, continence disturbance, or symptom recurrence.

    Time frame: Up to 6 months post-surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Oct 2026; primary completion for Apr 2027, 6 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 6 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 13, 2026
First posted
Sep 17, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Sep 17, 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 Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07824999
Lead sponsor
Sohag University
Responsible party
Keroless Mohareb Abdelmalak (Resident of General Surgery, Oncological and Laparoscopic Surgery, Sohag University) — Principal investigator
First posted
Sep 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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