Excisional Hemorrhoidectomy
Conditions
Brief summary
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.
Interventions
DEVICESlotted Anoscope
SA411
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration (Surgery Time) | Time of surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Slotted Anoscope Subjects consenting to have hemorrhoidectomy with the slotted anoscope | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Slotted Anoscope |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Procedure Duration (Surgery Time)
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.
Time frame: Time of surgery
Population: No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.