HemorrhoidNCT07846904
Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
A study testing Open Milligan-Morgan Hemorrhoidectomy and Laser Hemorrhoidoplasty in people with Hemorrhoid, run by Allied Hospital Faisalabad.
Trial summary
Hemorrhoidal disease is a common condition that can cause symptoms such as rectal bleeding and protrusion of tissue through the anal canal. For patients with symptomatic grade II, III, or IV internal hemorrhoids who require surgery, different surgical techniques are available. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Open Milligan-Morgan Hemorrhoidectomy and Laser Hemorrhoidoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Adult patients aged 20-50 years. Patients of either sex. Patients diagnosed with symptomatic Grade II, III, or IV internal hemorrhoids based on clinical examination and proctoscopy/anoscopy.
Patients fit for elective surgery under anesthesia, classified as ASA physical status I or II.
Patients providing written informed consent to participate in the study. Exclusion Criteria Pregnant females. Patients with Grade I hemorrhoids or purely external hemorrhoids. Patients presenting with strangulated, thrombosed, or gangrenous hemorrhoids requiring emergency surgical intervention.
Patients with associated anorectal pathologies, including anal fissure, fistula-in-ano, inflammatory bowel disease, or anorectal malignancy.
Patients with bleeding diathesis or deranged coagulation profiles, including prolonged PT, APTT, or INR.
Patients with chronic liver disease or portal hypertension. Patients classified as ASA physical status III or IV. Immunocompromised patients, including those with confirmed HIV infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Postoperative Pain Between Laser Haemorrhoidoplasty and Open Haemorrhoidectomy
Hemorrhoidal disease is a common condition that can cause symptoms such as rectal bleeding and protrusion of tissue through the anal canal. For patients with symptomatic grade II, III, or IV internal hemorrhoids who require surgery, different surgical techniques are available.
This randomized controlled trial will compare postoperative pain between two surgical treatments for hemorrhoids: laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The study will include adult patients aged 20-50 years with symptomatic grade II, III, or IV internal hemorrhoids who are suitable for elective surgery.
Read more
A total of 68 participants will be enrolled and randomly allocated in a 1:1 ratio to either open Milligan-Morgan hemorrhoidectomy or laser hemorrhoidoplasty. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The primary outcome will be the VAS pain score 24 hours after surgery. Pain will also be assessed 72 hours after surgery as a secondary outcome.
The study will also record the need for rescue analgesia and the total amount of rescue tramadol administered during the first 72 hours after surgery. Relevant postoperative complications will also be monitored.
The purpose of the study is to determine whether there is a difference in postoperative pain between laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The findings may provide locally relevant information regarding postoperative pain and early recovery following these two surgical approaches.
Read the detailed description
Hemorrhoidal disease is associated with symptomatic enlargement and/or prolapse of the anal cushions and is a common anorectal condition. Although many patients can be managed conservatively or with office-based procedures, symptomatic hemorrhoids with persistent symptoms or significant prolapse may require surgical treatment.
Open Milligan-Morgan hemorrhoidectomy is an established surgical treatment for advanced symptomatic hemorrhoidal disease. Its effectiveness is accompanied by postoperative surgical wounds, which may contribute to postoperative pain and delayed recovery. Laser hemorrhoidoplasty is a less invasive, non-excisional technique in which laser energy is delivered submucosally to produce thermal coagulation and subsequent shrinkage of hemorrhoidal tissue.
Previous comparative evidence has suggested that laser hemorrhoidoplasty may be associated with less postoperative pain and reduced analgesic requirements compared with conventional excisional hemorrhoidectomy. However, comparative evidence from South Asian populations remains limited. In addition, the use of laser hemorrhoidoplasty in a high-volume public-sector tertiary care setting involves specialized equipment and consumables, making evaluation of its clinical outcomes in the local setting relevant.
This randomized controlled trial has been designed to directly compare postoperative pain following laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. Pain will be evaluated using a standardized Visual Analogue Scale, with assessment performed before administration of scheduled postoperative analgesia to reduce the potential influence of analgesic administration on pain measurement.
The study will also examine postoperative analgesic requirements and relevant postoperative complications. The findings are intended to provide locally relevant clinical evidence regarding postoperative pain and early postoperative recovery following these two surgical approaches.
- Conditions
- Hemorrhoid
- Being tested
- Open Milligan-Morgan Hemorrhoidectomy, Laser Hemorrhoidoplasty
- Keywords
- Hemorrhoids, Internal hemorrhoids, Laser hemorrhoidoplasty, Milligan-Morgan hemorrhoidectomy, Postoperative pain, Visual Analogue Scale, Hemorrhoidectomy, Rescue analgesia, Randomized controlled trial
- 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.
Open Milligan-Morgan HemorrhoidectomyProcedure or surgery
Participants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. The procedure will be performed as per the standard surgical practice of the institution.
Laser HemorrhoidoplastyProcedure or surgery
Participants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. Laser energy will be applied using a submucosal approach to produce thermal coagulation followed by shrinkage of the hemorrhoidal tissue.
| Study group | Role | What they receive |
|---|---|---|
| Open Milligan-Morgan Hemorrhoidectomy | Active comparator | Participants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for symptomatic grade II, III, or IV internal hemorrhoids. Receives: Procedure: Open Milligan-Morgan Hemorrhoidectomy |
| Laser Hemorrhoidoplasty | Experimental | Participants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for symptomatic grade II, III, or IV internal hemorrhoids. Receives: Procedure: Laser Hemorrhoidoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Measured: 24 hours after surgery (postoperative day 1), before administration of the scheduled postoperative analgesic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Basit, Allied Hospital Faisalabad
- Investigators
- Muhammad Faisal Bilal Lodhi, MBBS, FCPS General Surgery, Study chair, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846904
- Sponsor's protocol ID
- 48.ERC/FMU/2024-25-23
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared with other researchers because no data-sharing plan has been established for this study. Study data will be used for the planned statistical analysis and reporting of the study findings.
Publications
Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
PubMed 38294832Wee IJY, Koo CH, Seow-En I, Ng YYR, Lin W, Tan EJK. Laser hemorrhoidoplasty versus conventional hemorrhoidectomy for grade II/III hemorrhoids: a systematic review and meta-analysis. Ann Coloproctol. 2023 Feb;39(1):3-10. doi: 10.3393/ac.2022.00598.0085. Epub 2023 Jan 3.
PubMed 36593573Tan VZZ, Peck EW, Sivarajah SS, Tan WJ, Ho LML, Ng JL, Chong C, Aw D, Mainza F, Foo FJ, Koh FH. Systematic review and meta-analysis of postoperative pain and symptoms control following laser haemorrhoidoplasty versus Milligan-Morgan haemorrhoidectomy for symptomatic haemorrhoids: a new standard. Int J Colorectal Dis. 2022 Aug;37(8):1759-1771. doi: 10.1007/s00384-022-04225-4. Epub 2022 Jul 29.
PubMed 35906356Naderan M, Shoar S, Nazari M, Elsayed A, Mahmoodzadeh H, Khorgami Z. A Randomized Controlled Trial Comparing Laser Intra-Hemorrhoidal Coagulation and Milligan-Morgan Hemorrhoidectomy. J Invest Surg. 2017 Oct;30(5):325-331. doi: 10.1080/08941939.2016.1248304. Epub 2016 Nov 2.
PubMed 27806213
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Between Laser Haemorrhoidoplasty and Open Haemorrhoidectomy
- ClinicalTrials.gov ID
- NCT07846904
- Acronym / sponsor ID
- 48.ERC/FMU/2024-25-23
- Conditions
- Hemorrhoid
- Keywords
- Hemorrhoids, Internal hemorrhoids, Laser hemorrhoidoplasty, Milligan-Morgan hemorrhoidectomy, Postoperative pain, Visual Analogue Scale, Hemorrhoidectomy, Rescue analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 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 common condition that can cause symptoms such as rectal bleeding and protrusion of tissue through the anal canal. For patients with symptomatic grade II, III, or IV internal hemorrhoids who require surgery, different surgical techniques are available.
This randomized controlled trial will compare postoperative pain between two surgical treatments for hemorrhoids: laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The study will include adult patients aged 20-50 years with symptomatic grade II, III, or IV internal hemorrhoids who are suitable for elective surgery.
A total of 68 participants will be enrolled and randomly allocated in a 1:1 ratio to either open Milligan-Morgan hemorrhoidectomy or laser hemorrhoidoplasty. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The primary outcome will be the VAS pain score 24 hours after surgery. Pain will also be assessed 72 hours after surgery as a secondary outcome.
The study will also record the need for rescue analgesia and the total amount of rescue tramadol administered during the first 72 hours after surgery. Relevant postoperative complications will also be monitored.
The purpose of the study is to determine whether there is a difference in postoperative pain between laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The findings may provide locally relevant information regarding postoperative pain and early recovery following these two surgical approaches.
Detailed description
Hemorrhoidal disease is associated with symptomatic enlargement and/or prolapse of the anal cushions and is a common anorectal condition. Although many patients can be managed conservatively or with office-based procedures, symptomatic hemorrhoids with persistent symptoms or significant prolapse may require surgical treatment.
Open Milligan-Morgan hemorrhoidectomy is an established surgical treatment for advanced symptomatic hemorrhoidal disease. Its effectiveness is accompanied by postoperative surgical wounds, which may contribute to postoperative pain and delayed recovery. Laser hemorrhoidoplasty is a less invasive, non-excisional technique in which laser energy is delivered submucosally to produce thermal coagulation and subsequent shrinkage of hemorrhoidal tissue.
Previous comparative evidence has suggested that laser hemorrhoidoplasty may be associated with less postoperative pain and reduced analgesic requirements compared with conventional excisional hemorrhoidectomy. However, comparative evidence from South Asian populations remains limited. In addition, the use of laser hemorrhoidoplasty in a high-volume public-sector tertiary care setting involves specialized equipment and consumables, making evaluation of its clinical outcomes in the local setting relevant.
This randomized controlled trial has been designed to directly compare postoperative pain following laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. Pain will be evaluated using a standardized Visual Analogue Scale, with assessment performed before administration of scheduled postoperative analgesia to reduce the potential influence of analgesic administration on pain measurement.
The study will also examine postoperative analgesic requirements and relevant postoperative complications. The findings are intended to provide locally relevant clinical evidence regarding postoperative pain and early postoperative recovery following these two surgical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Milligan-Morgan Hemorrhoidectomy | Active comparator | Procedure: Open Milligan-Morgan HemorrhoidectomyParticipants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for symptomatic grade II, III, or IV internal hemorrhoids. |
| Laser Hemorrhoidoplasty | Experimental | Procedure: Laser HemorrhoidoplastyParticipants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for symptomatic grade II, III, or IV internal hemorrhoids. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Open Milligan-Morgan HemorrhoidectomyParticipants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. The procedure will be performed as per the standard surgical practice of the institution. | Procedure or surgery | Open Milligan-Morgan Hemorrhoidectomy |
| Laser HemorrhoidoplastyParticipants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. Laser energy will be applied using a submucosal approach to produce thermal coagulation followed by shrinkage of the hemorrhoidal tissue. | Procedure or surgery | Laser Hemorrhoidoplasty |
Primary outcome
Postoperative pain score
Time frame: 24 hours after surgery (postoperative day 1), before administration of the scheduled postoperative analgesic
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
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 29 Sep 2026.
- Background: PubMed 38294832Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
- Background: PubMed 36593573Wee IJY, Koo CH, Seow-En I, Ng YYR, Lin W, Tan EJK. Laser hemorrhoidoplasty versus conventional hemorrhoidectomy for grade II/III hemorrhoids: a systematic review and meta-analysis. Ann Coloproctol. 2023 Feb;39(1):3-10. doi: 10.3393/ac.2022.00598.0085. Epub 2023 Jan 3.
- Background: PubMed 35906356Tan VZZ, Peck EW, Sivarajah SS, Tan WJ, Ho LML, Ng JL, Chong C, Aw D, Mainza F, Foo FJ, Koh FH. Systematic review and meta-analysis of postoperative pain and symptoms control following laser haemorrhoidoplasty versus Milligan-Morgan haemorrhoidectomy for symptomatic haemorrhoids: a new standard. Int J Colorectal Dis. 2022 Aug;37(8):1759-1771. doi: 10.1007/s00384-022-04225-4. Epub 2022 Jul 29.
- Background: PubMed 27806213Naderan M, Shoar S, Nazari M, Elsayed A, Mahmoodzadeh H, Khorgami Z. A Randomized Controlled Trial Comparing Laser Intra-Hemorrhoidal Coagulation and Milligan-Morgan Hemorrhoidectomy. J Invest Surg. 2017 Oct;30(5):325-331. doi: 10.1080/08941939.2016.1248304. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared with other researchers because no data-sharing plan has been established for this study. Study data will be used for the planned statistical analysis and reporting of the study findings.
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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.
Muhammad Faisal Bilal Lodhi, MBBS, FCPS General Surgery study chair
Allied Hospital Faisalabad
Questions about this trial
What is this clinical trial studying?
A study testing Open Milligan-Morgan Hemorrhoidectomy and Laser Hemorrhoidoplasty in people with Hemorrhoid, run by Allied Hospital Faisalabad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Abdul Basit, MBBS (+92 301 6705830, abdulbasit.ab361@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 24 hours after surgery (postoperative day 1), before administration of the scheduled postoperative analgesic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07846904, which also lists 4 linked publications.
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 29 Sep 2026.