HemorrhoidsNCT07824999
Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids
A study testing Energy-based sutureless hemorrhoidectomy and Conventional Milligan-Morgan hemorrhoidectomy in people with Hemorrhoids, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Energy-based sutureless hemorrhoidectomy and Conventional Milligan-Morgan hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital, Department of General Surgery
Sohag, 82749
Kerolos Mohareb Abdelmalak, MBBCh, 01282319310, moharebkero74@gmail.com
About this study
Official title: Sutureless Hemorrhoidectomy Versus Conventional Ligation: A Comparative Prospective Randomized Clinical 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.
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.
- Conditions
- Hemorrhoids
- Being tested
- Energy-based sutureless hemorrhoidectomy, Conventional Milligan-Morgan hemorrhoidectomy
- Keywords
- Sutureless hemorrhoidectomy, LigaSure, Harmonic Scalpel, Milligan-Morgan, Postoperative pain
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy-based sutureless hemorrhoidectomyProcedure or surgery
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 hemorrhoidectomyProcedure or surgery
Standard Milligan-Morgan hemorrhoidectomy with surgical dissection of hemorrhoidal columns and absorbable suture transfixion and ligation of vascular pedicles.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ligation Hemorrhoidectomy Group | Active comparator | Patients undergoing conventional excisional hemorrhoidectomy using the Milligan-Morgan technique with suture ligation of the vascular pedicle. Receives: Procedure: Conventional Milligan-Morgan hemorrhoidectomy |
| Sutureless Hemorrhoidectomy Group | Experimental | Patients undergoing sutureless excisional hemorrhoidectomy using an energy-based vessel sealing device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation. Receives: Procedure: Energy-based sutureless hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Assessed using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst imaginable pain) at fixed postoperative intervals.
Measured: Up to 6 months post-surgery
Incidence of Postoperative Bleeding
Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission.
Measured: Up to 6 months post-surgery
Secondary outcomes (7)
Operative Time
Duration in minutes from the initiation of tissue excision to complete surgical hemostasis.
Measured: Intraoperative (at time of surgery)
Intraoperative Blood Loss
Estimated intraoperative blood loss measured in milliliters.
Measured: Intraoperative (at time of surgery)
Total Postoperative Analgesic Requirement
Total analgesic dosage, type, and duration required for postoperative pain management.
Measured: Up to 6 months post-surgery
Time to Complete Wound Healing
Clinical assessment of complete re-epithelialization of the anal wounds documented in weeks/months.
Measured: Assessed at 1 week, 2 weeks, 1 month, 3 months, and 6 months
Length of Hospital Stay
Duration of postoperative stay in hours/days from operation until fulfilling discharge criteria.
Measured: From surgical admission up to discharge (average 1-2 days)
Time to Return to Normal Activity
Recorded in days from surgery until the patient comfortably resumes routine daily non-strenuous activities.
Measured: Up to 6 months post-surgery
Rate of Postoperative Complications and Recurrence
Incidence of urinary retention, wound infection, anal stenosis, continence disturbance, or symptom recurrence.
Measured: Up to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keroless Mohareb Abdelmalak, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824999
- Sponsor's protocol ID
- Soh-Med-Surg-2026-KM
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Hemorrhoidectomy Versus Conventional Ligation: A Comparative Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07824999
- Acronym / sponsor ID
- Soh-Med-Surg-2026-KM
- Conditions
- Hemorrhoids
- Keywords
- Sutureless hemorrhoidectomy, LigaSure, Harmonic Scalpel, Milligan-Morgan, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Ligation Hemorrhoidectomy Group | Active comparator | Procedure: Conventional Milligan-Morgan hemorrhoidectomyPatients undergoing conventional excisional hemorrhoidectomy using the Milligan-Morgan technique with suture ligation of the vascular pedicle. |
| Sutureless Hemorrhoidectomy Group | Experimental | Procedure: Energy-based sutureless hemorrhoidectomyPatients undergoing sutureless excisional hemorrhoidectomy using an energy-based vessel sealing device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy-based sutureless hemorrhoidectomyExcision of hemorrhoidal columns with vessel pedicle sealing using an energy-based device (LigaSure or Harmonic Scalpel) without conventional pedicle transfixion or suture ligation. | Procedure or surgery | Sutureless Hemorrhoidectomy Group |
| Conventional Milligan-Morgan hemorrhoidectomyStandard Milligan-Morgan hemorrhoidectomy with surgical dissection of hemorrhoidal columns and absorbable suture transfixion and ligation of vascular pedicles. | Procedure or surgery | Conventional Ligation Hemorrhoidectomy Group |
Primary outcome
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.
Incidence of Postoperative Bleeding
Time frame: Up to 6 months post-surgery
Evaluation of early or delayed postoperative perianal bleeding requiring intervention or readmission.
7 secondary outcomes
Operative Time
Time frame: Intraoperative (at time of surgery)
Intraoperative Blood Loss
Time frame: Intraoperative (at time of surgery)
Total Postoperative Analgesic Requirement
Time frame: Up to 6 months post-surgery
Time to Complete Wound Healing
Time frame: Assessed at 1 week, 2 weeks, 1 month, 3 months, and 6 months
Length of Hospital Stay
Time frame: From surgical admission up to discharge (average 1-2 days)
Time to Return to Normal Activity
Time frame: Up to 6 months post-surgery
Rate of Postoperative Complications and Recurrence
Time frame: Up to 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sohag University Hospital, Department of General Surgery
Sohag, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy-based sutureless hemorrhoidectomy and Conventional Milligan-Morgan hemorrhoidectomy in people with Hemorrhoids, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: Up to 6 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.