Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy
This study has been terminated.
(Slow Enrollment)
Sponsor:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01264835
First received: December 17, 2010
Last updated: February 1, 2012
Last verified: February 2012
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Purpose
This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.
| Condition | Intervention |
|---|---|
|
Excisional Hemorrhoidectomy |
Device: Slotted Anoscope |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Ethicon Endo-Surgery:
Primary Outcome Measures:
- Procedure Duration (Surgery Time) [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.
| Enrollment: | 2 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Slotted Anoscope
SA411
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are at least 18 years of age
- Are willing to give consent and comply with evaluation and treatment schedule
- Meet institutional criteria for excisional hemorrhoidectomy
- Are able to understand and complete study questionnaires.
Exclusion Criteria:
- Previous Hemorrhoid surgery
- Chronic daily narcotic use
- Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
- Internal hemorrhoids that may be suitable for office management (surgeon discretion)
- Fecal or urinary incontinence
- Inflammatory Bowel Disease (Crohns, ulcerative colitis)
- Acutely thrombosed hemorrhoids (surgeon discretion)
- Evidence of acute sepsis or the presence of a fistula
- Anal stricture.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264835
Locations
| United States, Alabama | |
| University of South Alabama | |
| Mobile, Alabama, United States, 36693 | |
| United States, Georgia | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
Ethicon Endo-Surgery
More Information
No publications provided
| Responsible Party: | Ethicon Endo-Surgery |
| ClinicalTrials.gov Identifier: | NCT01264835 History of Changes |
| Other Study ID Numbers: | CI-10-0003 |
| Study First Received: | December 17, 2010 |
| Results First Received: | November 28, 2011 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 13, 2013