Viewing Study NCT00397137



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00397137
Status: COMPLETED
Last Update Posted: 2019-04-02
First Post: 2006-11-07

Brief Title: Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids
Sponsor: University of Dundee
Organization: University of Dundee

Study Overview

Official Title: Prospective Randomized Multi-centre Trial Comparing the Clinical Efficacy Safety and Patient Acceptability of Circular Stapled Anopexy With Closed Diathermy Haemorrhoidectomy for Haemorrhoids
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment which is excisional haemorrhoidectomy
Detailed Description: The current gold standard treatment of haemorrhoids namely excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain However with the wound in the sensitive anoderm following excisional haemorrhoidectomy pain continues to be a major problem irrespective of the method of excision or of the instrument employed

The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound This should result in reduction of the postoperative pain and subsequently should improve the recovery time Further potential advantages of the technique should include a more physiological approach to the treatment of the disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None