Trial Outcomes & Findings for A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite (NCT NCT01305473)

NCT ID: NCT01305473

Last Updated: 2012-08-01

Results Overview

A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.

• Recruitment status: COMPLETED
• Target enrollment: 90 participants
• Primary outcome timeframe: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
• Results posted on: 2012-08-01

Participant Flow

Between October 2010 and February 2011, a total of 90 subjects were enrolled at a single study site.

Participant milestones

Measure	Sepramesh Group Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

Baseline characteristics by cohort

Measure	Sepramesh Group n=90 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Age Continuous	56.0 years STANDARD_DEVIATION 12.23 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants
Weight	98.5 kilograms STANDARD_DEVIATION 23.92 • n=5 Participants
Height	170.3 centimeters STANDARD_DEVIATION 10.16 • n=5 Participants
Body Mass Index	33.9 kilograms per square meter STANDARD_DEVIATION 7.36 • n=5 Participants
Hernia Classification Umbilical	43 participants n=5 Participants
Hernia Classification Incisional	42 participants n=5 Participants
Hernia Classification Umbilical and Incisional	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Population: All enrolled subjects were included in the analysis.

A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.

Outcome measures

Measure	Sepramesh Group n=90 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.	1 participants

SECONDARY outcome

Timeframe: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Population: All enrolled subjects were included in the analysis.

Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).

Outcome measures

Measure	Sepramesh Group n=90 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Complications in Subjects With Hernias Repaired With Sepramesh.	2 participants

SECONDARY outcome

Timeframe: Day 0

Population: All enrolled subjects were included in the analysis.

Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).

Outcome measures

Measure	Sepramesh Group n=90 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Procedural Time for Sepramesh Placement.	41.4 minutes Standard Deviation 20.56

SECONDARY outcome

Timeframe: 12 months or greater (average follow-up time of 3 years; range 13-65 months)

Population: Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.

Recovery time will be defined as the time it took for the subject to return to work.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: 12 months or greater

Population: The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.

A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.

Outcome measures

Measure	Sepramesh Group n=42 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.	1 participants

POST_HOC outcome

Timeframe: 12 months or greater

Population: The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.

A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.

Outcome measures

Measure	Sepramesh Group n=43 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.	0 participants

POST_HOC outcome

Timeframe: 12 months or greater

Population: This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.

A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.

Outcome measures

Measure	Sepramesh Group n=5 Participants Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias	0 participants

Adverse Events

Sepramesh Group

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sepramesh Group n=90 participants at risk Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
Injury, poisoning and procedural complications Incisional hernia	1.1% 1/90 • Number of events 1 • Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact. Adverse events (or complications) were defined as any undesirable clinical event occurring in the abdominal skin, abdominal wall, involving abdominal organs and/or any other event judged to be related to the surgical procedure of Sepramesh Composite.
Injury, poisoning and procedural complications Seroma	1.1% 1/90 • Number of events 1 • Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact. Adverse events (or complications) were defined as any undesirable clinical event occurring in the abdominal skin, abdominal wall, involving abdominal organs and/or any other event judged to be related to the surgical procedure of Sepramesh Composite.
Injury, poisoning and procedural complications Postoperative hernia	1.1% 1/90 • Number of events 1 • Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact. Adverse events (or complications) were defined as any undesirable clinical event occurring in the abdominal skin, abdominal wall, involving abdominal organs and/or any other event judged to be related to the surgical procedure of Sepramesh Composite.

Other adverse events

Measure

Sepramesh Group n=90 participants at risk Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.

Gastrointestinal disorders Abdominal pain lower

1.1% 1/90 • Number of events 1 • Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact. Adverse events (or complications) were defined as any undesirable clinical event occurring in the abdominal skin, abdominal wall, involving abdominal organs and/or any other event judged to be related to the surgical procedure of Sepramesh Composite.

Additional Information

Dawn Heimer/Director, Clinical Affairs

C.R. Bard: Davol, Inc.

Phone: 401-825-8681

Email: dawn.heimer@crbard.com

Results disclosure agreements

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

Restriction type: GT60