Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Duration of analgesia
Overview
Brief Summary
This prospective cohort study evaluates whether combining "suture mucopexy" (a simple stitch-based lift of prolapsed tissue) with Laser Hemorrhoidoplasty (LHP) can effectively relieve pain, bleeding and prolapse in adults with moderate-to-severe hemorrhoids (Grades II-IV). Participants will undergo the combined, non-Doppler-guided procedure and be followed for one year. The primary question is how long patients need post-operative pain medication and if they first experience complete symptom relief; secondary questions examine quality-of-life, safety (bleeding, urinary retention, stenosis) and the rate of hemorrhoid recurrence/re-operation.
Detailed Description
Laser Hemorrhoidoplasty (LHP) offers a minimally invasive option for symptomatic hemorrhoids, yet in advanced disease (Goligher III/IV) recurrence rates of 20-35 % have been reported because residual mucosal prolapse persists. Adding a suture-based mucopexy (SM) eliminates the prolapse and ligates feeding vessels without the need for Doppler guidance, thereby potentially reducing recurrence while preserving the low-pain advantage of LHP. Preliminary experience with 50 patients at this centre demonstrated feasibility, low early complication rates, and promising symptom control, justifying a formal prospective evaluation.
The present study is a single-center, prospective observational cohort enrolling consecutive eligible adults over a 24-month accrual period. All participants receive the same combined LHP + SM technique; no comparator arm is planned. Follow-up visits occur at postoperative week 6, month 6 and month 12.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (\>18 years).
- •Symptomatic Hemorrhoidal Disease (Goligher Grades II, III, IV).
- •Patients with or without recurrent disease after prior procedures (e.g., RBL, infrared coagulation, Milligan-Morgan, etc).
Exclusion Criteria
- •Acutely thrombosed hemorrhoids.
- •Concomitant anal fistula or abscess requiring separate surgical management.
- •IBD (Crohn's/Ulcerative Colitis) with active rectal involvement.
- •Previous Stapled Haemorrhoidopexy (SH/Longo).
Outcomes
Primary Outcomes
Duration of analgesia
Time Frame: perioperatively
Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.
Primary Symptom Relief
Time Frame: perioperatively
Patient-reported cessation of bleeding and/or pain.
Secondary Outcomes
- Morbidity(3 months)
- Complications(12 months)
- Reoperation Rate(12 months)
- Nyström Hemorrhoid Severity Score (HSS)(12 months)
Investigators
George Theodoropoulos
Professor
National and Kapodistrian University of Athens