Trial Outcomes & Findings for Radial Reload Open LAR Case Series (NCT NCT01717014)

NCT ID: NCT01717014

Last Updated: 2015-03-02

Results Overview

The surgeons ability to achieve a staple line at the desired level of the rectum.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: Operative
• Results posted on: 2015-03-02

Participant Flow

Participant milestones

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radial Reload Open LAR Case Series

Baseline characteristics by cohort

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Age, Continuous	55.6 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Height	175.1 centimeters STANDARD_DEVIATION 4.3 • n=5 Participants
Weight	88.7 kilograms STANDARD_DEVIATION 18.0 • n=5 Participants
Body Mass Index (BMI)	29.0 kg/m2 STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: Operative

The surgeons ability to achieve a staple line at the desired level of the rectum.

Outcome measures

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Staple Line	7 participants

PRIMARY outcome

Timeframe: Operative

The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.

Outcome measures

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Distal Margins	8 participants

SECONDARY outcome

Timeframe: Operatively

Visibility measured by surgeon usability questionnaire.

Outcome measures

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Usability: Visibility Visibility adequate when RR was used operatively	100 % of cases surgeon agree/strongly agree
Usability: Visibility Did instrument impede visibility	0 % of cases surgeon agree/strongly agree

SECONDARY outcome

Timeframe: Operatively

Access measured by surgeon usability questionnaire

Outcome measures

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Usability: Access Radial Reload (RR) easy to place in pelvis	100 % of cases surgeon agree/strongly agree
Usability: Access RR was able to get low in pelvis	100 % of cases surgeon agree/strongly agree
Usability: Access RR was easy to place in the colon & rectum	100 % of cases surgeon agree/strongly agree
Usability: Access Was rectum contained in the device after clamping	12.5 % of cases surgeon agree/strongly agree
Usability: Access RR retained an adequate tissue during clamping	100 % of cases surgeon agree/strongly agree
Usability: Access Was the rectum transected in one firing	12.5 % of cases surgeon agree/strongly agree

SECONDARY outcome

Timeframe: Operatively

Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate

Outcome measures

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 Participants Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Usability: Manueverability	87.5 % of cases surgeon agree/strongly agree

Adverse Events

Covidien Radial Reload Stapler With Tri-Staple Technology

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 participants at risk Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Gastrointestinal disorders Ileus	25.0% 2/8 • Number of events 2 • Adverse events were collected through the 30 day follow-up visit
Infections and infestations Pelvic abscess	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Infections and infestations Perirectal abscess	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Renal and urinary disorders Renal failure acute	25.0% 2/8 • Number of events 2 • Adverse events were collected through the 30 day follow-up visit
Renal and urinary disorders Urinary retention	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit

Other adverse events

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology n=8 participants at risk Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
Renal and urinary disorders Urinary retention	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Injury, poisoning and procedural complications Post-operative ileus	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit

Additional Information

Julie Doyle

Covidien

Phone: 781-839-1729

Email: Julie.Doyle@Covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place