Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hemorrhoids |
Procedure: Circular stapled anopexy Procedure: Closed diathermy haemorrhoidectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Postoperative pain
- global haemorrhoidal symptom control
- complication rates
- Time to recovery
- Time to return to work
- Re-treatment rates
- Day case surgeries
- Quality of life changes
- Patient satisfaction
- Cost effectiveness
| Estimated Enrollment: | 182 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | December 2003 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult human subjects (age >=16 years) with symptomatic haemorrhoids (Primary or recurrent)
- symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment
Exclusion Criteria:
- concurrent untreated or recurrent colorectal cancer
- Active inflammatory bowel disease
- Previous major anorectal surgery
- On anticoagulant medications
- Non-consenting patients
- Unwilling for randomisation
Contacts and Locations| United Kingdom | |
| Ninewells Hospital & Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Principal Investigator: | Robert JC Steele, MD | University of Dundee |
| Principal Investigator: | Mohamed A Thaha, MRCS | University of Dundee |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00397137 History of Changes |
| Other Study ID Numbers: | 202/99 |
| Study First Received: | November 7, 2006 |
| Last Updated: | November 7, 2006 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Dundee:
|
Symptomatic haemorrhoids haemorrhoidectomy stapled anopexy |
Additional relevant MeSH terms:
|
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013