Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids
ConditionHemorrhoids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSohag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Energy-based sutureless hemorrhoidectomy
Procedure/SurgeryExcision of hemorrhoidal columns with vessel pedicle sealing using an energy-based device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation.
Conventional Milligan-Morgan hemorrhoidectomy
Procedure/SurgeryStandard Milligan-Morgan hemorrhoidectomy with surgical dissection of hemorrhoidal columns and absorbable suture transfixion and ligation of vascular pedicles.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Conventional Ligation Hemorrhoidectomy GroupActive comparator 1 intervention
Group B: Sutureless Hemorrhoidectomy GroupExperimental treatment 1 intervention
Trial outcomes
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-surgery2
Incidence of Postoperative Bleeding
Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission.
Time frame
Up to 6 months post-surgerySecondary 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-surgery4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov