Trial Outcomes & Findings for SurgiMend Mesh at the Hiatus (NCT NCT04282720)

Results Overview

Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

6 months post surgery

Results posted on

2026-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	SurgiMend Mesh SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All 9 participants had the variable age collected and were included in a full cohort analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SurgiMend Mesh n=9 Participants SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members
Age, Continuous	64.7 years n=9 Participants • All 9 participants had the variable age collected and were included in a full cohort analysis.
Sex: Female, Male Female	9 Participants n=9 Participants • All 9 participants had the variable age collected and were included in a full cohort analysis.
Sex: Female, Male Male	0 Participants n=9 Participants • All 9 participants had the variable age collected and were included in a full cohort analysis.
GERD-HRQL survey	35.44 0-75 score on survey STANDARD_DEVIATION 18.035 • n=9 Participants

PRIMARY outcome

Timeframe: 6 months post surgery

Population: Due to inconsistent follow-up during the 2020 Pandemic, the investigators used only the 6-month follow up for analysis.

Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.

Outcome measures

Outcome measures
Measure	SurgiMend Mesh n=9 Participants SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members	Post-hernia Repair Score GERD-HRQL scale score performed after the repair.
Recurrence Rate No recurrence of hernia	6 Participants	—
Recurrence Rate recurrence of hernia	3 Participants	—

SECONDARY outcome

Timeframe: 6 month post surgery

Population: Due to inconsistent follow-up during the 2020 Pandemic, the investigators used only the 6-month follow up for analysis.

GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were combined due to some participants not having specific follow up information.

Outcome measures

Outcome measures
Measure	SurgiMend Mesh n=9 Participants SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members	Post-hernia Repair Score n=8 Participants GERD-HRQL scale score performed after the repair.
Quality of Life Using GERD-HRQL Scale Heartburn Score	15.67 score on a scale Standard Deviation 8.775	7.37 score on a scale Standard Deviation 9.086
Quality of Life Using GERD-HRQL Scale Regurgitation Score	15.44 score on a scale Standard Deviation 7.715	6.38 score on a scale Standard Deviation 9.349
Quality of Life Using GERD-HRQL Scale Total Score	35.44 score on a scale Standard Deviation 18.035	17.38 score on a scale Standard Deviation 22.564

Adverse Events

SurgiMend Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Levy

Kettering Health

Phone: +1(937)531-0195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place