Trial Outcomes & Findings for Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy (NCT NCT01264835)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Time of surgery

Results posted on

2012-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Slotted Anoscope Subjects consenting to have hemorrhoidectomy with the slotted anoscope
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Slotted Anoscope Subjects consenting to have hemorrhoidectomy with the slotted anoscope
Overall Study Lost to Follow-up	1

Baseline Characteristics

Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slotted Anoscope n=2 Participants Subjects consenting to have hemorrhoidectomy with the slotted anoscope
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Slotted Anoscope

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Slotted Anoscope n=2 participants at risk Subjects consenting to have hemorrhoidectomy with the slotted anoscope
Gastrointestinal disorders Rectal Ulceration	50.0% 1/2 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Michael Schwiers, Principal Biostatistician

Ethicon Endo-Surgery

Phone: 513-337-1172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60