NCT07678814

Brief Summary

Hemorrhoidal disease is one of the most common anorectal disorders. Conventional Milligan Morgan Hemorrhoidectomy remains the standard treatment but is associated with considerable postoperative pain. Laser Hemorrhoidoplasty has emerged as a minimally invasive alternative. This randomized controlled trial compares postoperative pain, patient satisfaction, and hospital stay between Laser Hemorrhoidoplasty and conventional hemorrhoidectomy in patients with Grade II and Grade III hemorrhoids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Laser HemorrhoidoplastyMilligan Morgan HemorrhoidectomyRandomized Controlled TrialPostoperative PainPatient Satisfaction

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain

    Pain measured using Visual Analogue Scale (VAS).

    Post Operative period: (6) Six Hourly in first 48 Hours, at 1 week post operative period & at 1 month post operatively.

  • Patient Satisfaction

    Patient satisfaction assessed using Likert-scale questionnaire.

    1 month postoperative

Study Arms (2)

Laser Hemorrhoidoplasty

EXPERIMENTAL

Patients underwent Laser Hemorrhoidoplasty using diode laser energy applied to hemorrhoidal tissue.

Procedure: Laser Hemorrhoidoplasty

Milligan Morgan Hemorrhoidectomy

ACTIVE COMPARATOR

Patients underwent conventional open Milligan Morgan Hemorrhoidectomy.

Procedure: Milligan Morgan Hemorrhoidectomy

Interventions

Patients randomized to the intervention group underwent Laser Hemorrhoidoplasty under spinal anesthesia. A diode laser probe was introduced into the hemorrhoidal tissue through a small mucosal entry point under direct visualization using an anoscope. Controlled laser energy was delivered submucosally to achieve coagulation, shrinkage, and fixation of the hemorrhoidal cushions while preserving the surrounding anoderm and mucosa. The procedure was performed according to standard surgical protocols with the aim of reducing postoperative pain, bleeding, and recovery time.

Laser Hemorrhoidoplasty

Patients randomized to the control group underwent conventional open Milligan Morgan Hemorrhoidectomy under spinal anesthesia. The hemorrhoidal pedicles were identified, ligated, and excised using standard surgical techniques. The wounds were left open with preservation of mucocutaneous bridges between excision sites. Hemostasis was achieved as required. Patients received routine postoperative care and follow-up according to institutional protocols.

Milligan Morgan Hemorrhoidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years Grade II hemorrhoids Grade III hemorrhoids Both genders

You may not qualify if:

  • Rectal prolapse Anal fissure Anorectal malignancy Pregnancy or lactating mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital, Lahore.

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pain, PostoperativePatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Muhammad, FCPS General Surgery Resident

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

September 1, 2025

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during the study will not be made publicly available. Data will remain confidential and will be retained by the investigators in accordance with institutional policies and ethical approval requirements.

Locations