Anorectal Diseases, Anorectal Surgeries, Haemorrhoid, Haemorrhoidal Bleeding
Conditions
Keywords
haemorrhoid, laser, mucopexy, suture mucopexy, LHP, haemorrhoidoplasty
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.
Interventions
PROCEDURELaser Haemorrhoidoplasty and Suture Mucopexy
The procedure combines laser ablation (LHP) with suture mucopexy (SM) performed without Doppler guidance. Suture Mucopexy (SM): Using a slotted proctoscope, continuous suture mucopexy (plication) is performed at standardized anatomical positions (typically 4, 7, 11 o'clock) to lift the prolapse and ligate feeding vessels. Sutures are placed approximately 2-4 cm proximal to the dentate line. Laser Hemorrhoidoplasty (LHP): A 1470nm diode laser fiber is inserted into the hemorrhoidal cushion. Energy is delivered (approx. 250-350 J per pile) to induce shrinkage and fibrosis.
Sponsors
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of analgesia | perioperatively | Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications. |
| Primary Symptom Relief | perioperatively | Patient-reported cessation of bleeding and/or pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nyström Hemorrhoid Severity Score (HSS) | 12 months | 5 items (pain, itching, bleeding, prolapse, soiling) scored 0-3 (higher score indicates worse symptoms), assessed at preoperative baseline, 6 weeks, 6 months, and 12 months. |
| Morbidity | 3 months | Postoperative morbidity (Clavien-Dindo classification), ranging from Grade I (minor, no intervention) to Grade V (death), at 30 days and 90 days. |
| Complications | 12 months | Postoperative complications, specifically tracking urinary retention, bleeding, and anal stenosis (yes/no) |
| Reoperation Rate | 12 months | Need for secondary surgical intervention for recurrence or complications. |
Countries
Greece
Contacts
CONTACTGeorge Theodoropoulos
Outcome results
None listed