Trial Outcomes & Findings for Radial Reload Laparoscopic LAR Case Series (NCT NCT01706822)

NCT ID: NCT01706822

Last Updated: 2015-03-18

Results Overview

The surgeon's ability to achieve a staple line at the desired level of the rectum.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: Operative
• Results posted on: 2015-03-18

Participant Flow

Participant milestones

Measure	Covidien Radial Reload Stapler With Tri-Staple Technology Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or 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 Laparoscopic 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 laparoscopic low anterior resection or proctosigmoidectomy
Age, Continuous	66.6 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 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	1 Participants n=5 Participants
Race (NIH/OMB) White	7 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	165.0 centimeters STANDARD_DEVIATION 11.9 • n=5 Participants
Weight	73.9 kilograms STANDARD_DEVIATION 16.4 • n=5 Participants
Body Mass Index (BMI)	27.0 kg/m2 STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: Operative

The surgeon's 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 laparoscopic low anterior resection or proctosigmoidectomy.
The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met	6 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 laparoscopic low anterior resection or proctosigmoidectomy.
The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met	7 participants

SECONDARY outcome

Timeframe: Operatively

1. 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 laparoscopic low anterior resection or proctosigmoidectomy.
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree Was the rectum contained in device after clamping	50 % of cases surgeon agree/strongly agree
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree Radial Reload (RR) easy to place in pelvis	62.5 % of cases surgeon agree/strongly agree
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree RR was easy to get low in the pelvis	87.5 % of cases surgeon agree/strongly agree
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree RR was easy to place in the colon and the rectum	50 % of cases surgeon agree/strongly agree
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree RR retained an adequate amount of tissue	75 % of cases surgeon agree/strongly agree
Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree Was the rectum transected with one firing	12.5 % of cases surgeon agree/strongly agree

SECONDARY outcome

Timeframe: Operatively

2. 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 laparoscopic low anterior resection or proctosigmoidectomy.
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree Visibility was adequate when RR was used	87.5 % of cases surgeon agree/strongly agree
Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree Did the instrument impede the visibility	0 % of cases surgeon agree/strongly agree

SECONDARY outcome

Timeframe: Operatively

3. Maneuverability 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 laparoscopic low anterior resection or proctosigmoidectomy.
Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree	62.5 % 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 laparoscopic low anterior resection or proctosigmoidectomy
Gastrointestinal disorders Ileus	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Gastrointestinal disorders Pneumoperitoneum	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Injury, poisoning and procedural complications Postoperative ileus	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Injury, poisoning and procedural complications Procedural complication	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Renal and urinary disorders Ureteric obstruction	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 laparoscopic low anterior resection or proctosigmoidectomy
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Adverse events were collected through the 30 day follow-up visit
Injury, poisoning and procedural complications Interoperative bleeding	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