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NCT Number: NCT07824999

Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital, Department of General Surgery

Sohag, 82749, Egypt

Location status: Recruiting

Location contact

Kerolos Mohareb Abdelmalak, MBBCh

CONTACT

[email protected]

01282319310

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 malignancy[cite: 1].
  • History of previous anorectal surgery[cite: 1].
  • Bleeding diathesis, uncontrolled anticoagulant therapy, or severe coagulopathy[cite: 1].

Treatment and study plan

Energy-based sutureless hemorrhoidectomy

Procedure

Excision 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

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

Primary outcomes

  1. Postoperative Pain Score

    Time frame: Up to 6 months post-surgery

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

  2. Incidence of Postoperative Bleeding

    Time frame: Up to 6 months post-surgery

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

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperative (at time of surgery)

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

  2. Intraoperative Blood Loss

    Time frame: Intraoperative (at time of surgery)

    Estimated intraoperative blood loss measured in milliliters.

  3. Total Postoperative Analgesic Requirement

    Time frame: Up to 6 months post-surgery

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

  4. Time to Complete Wound Healing

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

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

  5. Length of Hospital Stay

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

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

  6. Time to Return to Normal Activity

    Time frame: Up to 6 months post-surgery

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

  7. Rate of Postoperative Complications and Recurrence

    Time frame: Up to 6 months post-surgery

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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Sutureless Hemorrhoidectomy Versus Conventional Ligation: A Comparative Prospective Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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