PILE STOP Study (Prospective International triaL Evaluating Stapling Technique versus Open Procedure). A study comparing two surgical techniques for hemorrhoidal disease.

PILE STOP Study (Prospective International triaL Evaluating Stapling Technique versus Open Procedure). A prospective single-blinded randomized multi-center clinical trial comparing the clinical efficacy and patient acceptability of circular stapled haemorrhoidopexy (Longo’s technique) with open haemorrhoidopexy (Pakravan’s technique).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22213

Enrollment

200

Registered

2011-07-11

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhoids hemorrhoidopexy stapled hemorrhoidopexy proctology surgery

Interventions

Stapled haemorrhoidopexy (Longo’s technique): During stapled haemorrhoidpexy, a circular stapling device is passed into the anal canal which excises excess prolapse and creates a submucosal anastomosi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 18 years; 2. Symptoms of haemorrhoidal disease 2nd to 4th grade. In case of 2nd and 3rd grade haemorrhoidal disease, at least three attempts of Baron ligation must have preceded; 3. Primary of recurrent haemorrhoidal disease; 4. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute presentation (not elective); 2. Concurrent untreated or recurrent colorectal cancer; 3. Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months; 4. Active inflammatory bowel disease; 5. Previous major anorectal surgery; 6. A history of fecal incontinence; 7. Presence of severe rectal pain; 8. Presence of co-morbidities which, in the opinion of the investigator, will not be appropriate for the study; 9. ASA >3; 10. The patient is uncooperative or is not capable to return for routine outpatient follow-up; 11. On anticoagulant medications or a history of coagulopathy; 12. Pregnancy; 13. Non-consenting patients; 14. Unwilling for randomisation.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is a 2-years symptom-free period.	—

Secondary

Measure	Time frame
1. Postoperative pain incl pain during first bowel movement; 2. Early complication rates (within 30 days postoperative eg bleeding, urinary retention, fecal impaction); 3. Global haemorrhoidal symptom control; 4. Patient satisfaction; 5. Operating time; 6. Time of hospitalization directly postoperative; 7. Re-admission to hospital; 8. Time to recovery; 9. Time to return to work; 10. Day case surgeries; 11. Surgical-technical grade of difficulty to perform; 12. Late complications: anal stenosis, continence; 13. Re-treatment rates; 14. Need for additional skin tag excision; 15. Quality of life changes; 16. Cost effectiveness.	—

Measure

Time frame

1. Postoperative pain incl pain during first bowel movement; 2. Early complication rates (within 30 days postoperative eg bleeding, urinary retention, fecal impaction); 3. Global haemorrhoidal symptom control; 4. Patient satisfaction; 5. Operating time; 6. Time of hospitalization directly postoperative; 7. Re-admission to hospital; 8. Time to recovery; 9. Time to return to work; 10. Day case surgeries; 11. Surgical-technical grade of difficulty to perform; 12. Late complications: anal stenosis, continence; 13. Re-treatment rates; 14. Need for additional skin tag excision; 15. Quality of life changes; 16. Cost effectiveness.

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Contacts

Public ContactV. Tudyka

Surgical Department Laurentius Hospital Roermond Mgr Driessenstraat 6

tudyka@gmail.com+31 (0)475 382222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)