DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05925959

RecruitingPhase NA

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Lead sponsor

Benjamin T. Miller

Assets

Liraglutide / Semaglutide

Listed sites

2

Recruiting sites

2

Enrollment

258

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 40-55

Primary endpoint

•Abdominal core health-specific quality of life

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05925959
Org study ID23-418

Timeline

Milestones

Study start2023-06-19actual
Study first posted2023-06-29actual
Last update posted2026-03-23actual
Primary completion2027-06-01estimated
Study completion2027-06-01estimated

Assets

Investigational agents

LiraglutideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
•BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.

Exclusion criteria

•Lack of English language fluency
•Urgent need for repair as determined by surgeon judgement
•Pregnant patients
•Permanent stoma in place
•Isolated flank hernia
•Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
•BMI <40 or >55 kg/m2
•Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
•Obstructive symptoms

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
8
Other clinical outcomes
8
Weight & body composition
3
Other (unclassified)
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Body composition changes in weight

Time frame:1 year

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body composition changes in BMI

Time frame:1 year

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Body weight percentage loss

Time frame:1 year

≥10% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

8 endpoints
Primary/protocol endpoint

Abdominal core health-specific quality of life at 1 year

Time frame:1 year

descriptive, improvement

Secondary/protocol endpoint

Patient abdominal wall specific- quality of life with preoperative weight management program

Time frame:1 year

change from baseline, improvement

Secondary/protocol endpoint

Patient-reported pain changes with preoperative weight management program

Time frame:1 year

change from baseline, improvement

Secondary/protocol endpoint

Patient-reported quality of life changes with preoperative weight management program

Time frame:1 year

EQ-5D VAS

change from baseline, improvement

Secondary/protocol endpoint

Abdominal wall -specific quality of life short-term

Time frame:30 days

change from baseline, improvement

Secondary/protocol endpoint

Pain scores

Time frame:1 year

change from baseline, improvement

Secondary/protocol endpoint

Impact of 10% body weight loss

Time frame:1 year

descriptive, improvement

Secondary/protocol endpoint/low confidence

Bariatric surgery prior to hernia repair and abdominal wall specific quality of life

Time frame:1 year

descriptive

Other clinical outcomes

8 endpoints
Secondary/protocol endpoint

Hernia recurrence at 1 year

Time frame:1 year

categorical status, event

Secondary/protocol endpoint

Wound morbidity at 30 days

Time frame:30 days

composite event, event

componentssurgical site infection, surgical site occurrence, surgical site occurrence requiring procedural intervention

Secondary/protocol endpoint

Wound morbidity at 1 year

Time frame:1 year

composite event, event

Secondary/protocol endpoint

Impact of 10% body weight loss on wound complications

Time frame:1 year

threshold achievement, event

Secondary/protocol endpoint

Impact of 10% body weight loss on hernia recurrence

Time frame:1 year

categorical status, event

Secondary/protocol endpoint/low confidence

Urgent repair

Time frame:1 year

event count, event

Secondary/protocol endpoint/low confidence

Bariatric surgery prior to hernia repair and wounds

Time frame:1 year

event count, event

Secondary/protocol endpoint/low confidence

Bariatric surgery prior to hernia repair and hernia recurrence

Time frame:1 year

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Cost effective analysis

Time frame:1 year

descriptive

Secondary/protocol endpoint/low confidence

Weight management program adherence

Time frame:1 year

threshold achievement, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.