Trial Outcomes & Findings for Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair (NCT NCT03276871)

NCT ID: NCT03276871

Last Updated: 2020-07-22

Results Overview

Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Measured from start to end of procedure
• Results posted on: 2020-07-22

Participant Flow

Participant milestones

Measure	Balloon Dissection Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Overall Study STARTED	21	19
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair

Baseline characteristics by cohort

Measure	Balloon Dissection n=21 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	26 kg/m^2 n=5 Participants	25.7 kg/m^2 n=7 Participants	25.9 kg/m^2 n=5 Participants
Diabetes	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Smoking	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
COPD	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured from start to end of procedure

Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.

Outcome measures

Measure	Balloon Dissection n=21 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Operative Time	46 minutes Interval 33.0 to 63.0	43 minutes Interval 35.0 to 90.0

SECONDARY outcome

Timeframe: Postoperative day 1, Postoperative day 7 and Postoperative day 30

Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.

Outcome measures

Measure	Balloon Dissection n=21 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
NRS-11 Pain Scores NRS-11, Postop day 1	3 units on a scale Interval 2.0 to 4.0	4 units on a scale Interval 3.0 to 5.0
NRS-11 Pain Scores NRS-11, Postop day 7	2 units on a scale Interval 0.75 to 3.25	1.5 units on a scale Interval 0.25 to 3.0
NRS-11 Pain Scores NRS-11, 30-day	0.5 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.75

SECONDARY outcome

Timeframe: Intraoperative complications recorded during the procedure, up to closure of the incisions

Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate

Outcome measures

Measure	Balloon Dissection n=21 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Number of Participants With Intra-operative Complications	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after surgery

30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate

Outcome measures

Measure	Balloon Dissection n=21 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 Participants Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
30-day SSO (Surgical Site Occurrences) Rate	4 Participants	0 Participants

Adverse Events

Balloon Dissection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telescopic Dissection

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Balloon Dissection n=21 participants at risk Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 participants at risk Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Skin and subcutaneous tissue disorders Port site hernia requiring reoperation	0.00% 0/21 • The adverse event data were collected up to 30 days following surgery	5.3% 1/19 • Number of events 1 • The adverse event data were collected up to 30 days following surgery

Other adverse events

Measure	Balloon Dissection n=21 participants at risk Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector	Telescopic Dissection n=19 participants at risk Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Renal and urinary disorders Urinary retention	0.00% 0/21 • The adverse event data were collected up to 30 days following surgery	5.3% 1/19 • Number of events 1 • The adverse event data were collected up to 30 days following surgery

Additional Information

Aldo Fafaj

Cleveland Clinic

Phone: 2162195943

Email: fafaja@ccf.org

Results disclosure agreements

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