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


- candidate number10145
- NTR NumberNTR2981
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jul-2011
- Secondary IDs 
- Public TitlePILE STOP Study (Prospective International triaL Evaluating Stapling Technique versus Open Procedure). A study comparing two surgical techniques for hemorrhoidal disease.
- Scientific TitlePILE 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 (Longoís technique) with open haemorrhoidopexy (Pakravanís technique).
- ACRONYMPILE STOP Study
- hypothesisPakravan's technique is a new minimal invasive surgical technique for grade 2 to 4 hemorrhoids that fail conservative treatment. As in stapling, Pakravan's technique comprises a hemorrhoidopexy with the intention of preserving important hemorrhoidal tissue. However, Pakravan's technique is much less costly that the stapling technique that demands stapling devices. Hypothesis:
1. Pakravanís technique of open haemorrhoidopexy is an efficient treatment for 2nd to 4th grade haemorrhoids with a low short- and long-term recurrence rate, a low postoperative complication rate, low costs and high patient satisfaction;
2. Pakravanís technique of open haemorrhoidopexy is safe and feasible and can be performed in day care surgery;
3. Pakravanís technique of open haemorrhoidopexy is technically not demanding and can be easily taught to dedicated surgeons.
- Healt Condition(s) or Problem(s) studiedSurgical treatment, Hemorrhoids, Hemorrhoidopexy, Stapled hemorrhoidopexy, Proctology
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-jan-2015
- Target number of participants200
- InterventionsStapled haemorrhoidopexy (Longoís technique): During stapled haemorrhoidpexy, a circular stapling device is passed into the anal canal which excises excess prolapse and creates a submucosal anastomosis. This anastomosis is located proximal to the dentate line. The excising of a circular band of mucosal tissue cranial from the haemorrhoidal tissue results in repositioning and fixation of the prolapsed anal cushions. The haemorrhoidal tissue itself is preserved. Open haemorrhoidopexy (Pakravanís technique): In this technique a small strip of rectal mucosa 4 cm above the dentate line is excised. With a Z-shaped resorbable suture a pexy is performed that lifts the distal prolapsed haemorrhoidal tissue up in the anal canal. The scarring of the wound of the mucosectomy will result in fixaton of the elevated haemorrhoid, preventing recurrent prolaps.
- Primary outcomePrimary endpoint is a 2-years symptom-free period.
- Secondary outcome1. 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.
- TimepointsPatients will be followed postoperatively at the outpatient clinic or by telepone interviewing. Visits to the outpatient clinic will be scheduled on day 7, after 6 weeks and 6 months. A telephone interview will be done on day 1, after 3 months, 1 year and 2 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD V. Tudyka
- CONTACT for SCIENTIFIC QUERIESMD V. Tudyka
- Sponsor/Initiator University Hospital Maastricht (AZM), Laurentius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Covidien Nederland
- PublicationsPakravan F, Helmes C, Baeten C. Transanal open hemorrhoidopexy. Dis Colon Rectum. 2009 Mar;52(3):503-6.
- Brief summaryThe circular stapling technique as introduced by Longo in 1998 might become the new golden standard instead of the technique of haemorrhoidectomy. Circular stapling does not involve painful and slowly healing perianal wounds. The procedure is usually performed in day care. For these reasons, Longoís technique has gained wide-spread popularity. Unfortunately, long-term studies show a recurrence rate that is slightly higher than in haemorrhoidectomy. In addition, the costs of the circular stapling device are still high and a considerable disadvantage. However, we are convinced that the advantages outweigh the disadvantages. The fact that Longoís technique is a haemorrhoid preserving technique makes it favourable over other techniques. The key of the procedure is a circular pexy of tissue proximal from the haemorrhoidal tissue. In 2008 Pakravan presented a new technique in which open haemorrhoidopexy is performed. The technique consists of a selective pexy of prolapsing haemorrhoidal tissue and from this view is familiar to the above mentioned technique. An additional advantage is the fact that no special devices are needed and therefore the costs are relatively low. Early results of Pakravanís technique show good results. Long term results are not available until now.
- Main changes (audit trail)
- RECORD11-jul-2011 - 26-jul-2011


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