Hemorrhoids
Conditions
Keywords
Sutureless hemorrhoidectomy, LigaSure, Harmonic Scalpel, Milligan-Morgan, Postoperative pain
Brief 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.
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.
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.
Standard Milligan-Morgan hemorrhoidectomy with surgical dissection of hemorrhoidal columns and absorbable suture transfixion and ligation of vascular pedicles.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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\[cite: 1\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 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. |
| Incidence of Postoperative Bleeding | Up to 6 months post-surgery | Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative (at time of surgery) | Duration in minutes from the initiation of tissue excision to complete surgical hemostasis. |
| Intraoperative Blood Loss | Intraoperative (at time of surgery) | Estimated intraoperative blood loss measured in milliliters. |
| Total Postoperative Analgesic Requirement | Up to 6 months post-surgery | Total analgesic dosage, type, and duration required for postoperative pain management. |
| Time to Complete Wound Healing | 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. |
| Length of Hospital Stay | From surgical admission up to discharge (average 1-2 days) | Duration of postoperative stay in hours/days from operation until fulfilling discharge criteria. |
| Time to Return to Normal Activity | Up to 6 months post-surgery | Recorded in days from surgery until the patient comfortably resumes routine daily non-strenuous activities. |
| Rate of Postoperative Complications and Recurrence | Up to 6 months post-surgery | Incidence of urinary retention, wound infection, anal stenosis, continence disturbance, or symptom recurrence. |
Countries
Egypt
Outcome results
None listed