Abdominal Wall HerniaNCT05925959
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
A study testing Preoperative Weight Management Program in people with Abdominal Wall Hernia, run by Benjamin T. Miller at 2 sites in United States.
Trial summary
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Wall Hernia
- What is being tested?
- Preoperative Weight Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Megan Melland-Smith, MD, 312-907-1414, megan.mellandsmith@nm.org
Nancy Ly, MD, 262-455-1560, nancy.ly@nm.org
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Benjamin T Miller, MD, 2164068573, millerb35@ccf.org
About this study
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
Read the detailed description
This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
- Conditions
- Abdominal Wall Hernia
- Being tested
- Preoperative Weight Management Program
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Weight Management ProgramOther
The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Upfront Surgery | No intervention | Not described |
| Preoperative Weight Management Program | Active comparator | Not described Receives: Other: Preoperative Weight Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal core health-specific quality of life at 1 year
This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life.
Measured: 1 year
Secondary outcomes (20)
Hernia recurrence at 1 year
This will be based on based on the current consensus definition of hernia recurrence which considers CT scan reviewed by 3 blinded assessors, surgeon clinical exam, and patient-reported bulge.
Measured: 1 year
Wound morbidity at 30 days
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Measured: 30 days
Wound morbidity at 1 year
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Measured: 1 year
Body composition changes in weight
This includes comparative mean changes in body weight (kg) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up.
Measured: 1 year
Body composition changes in BMI
This includes comparative mean changes in BMI (kg/m2) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up.
Measured: 1 year
Patient abdominal wall specific- quality of life with preoperative weight management program
This includes difference in abdominal wall-specific quality of life using the HerQLes score (0-100 with higher scores indicating better abdominal wall-specific quality of life) in the weight loss arm before and after weight loss intervention.
Measured: 1 year
Patient-reported pain changes with preoperative weight management program
This includes difference in pain using the PROMIS 3a Pain Intensity Score (30.7-71.8 with higher scores indicating more pain) in the weight loss arm before and after weight loss intervention.
Measured: 1 year
Patient-reported quality of life changes with preoperative weight management program
This includes difference in overall quality of life using the EQ5D-5L with VAS (scored with an index value and a 0-100 score with higher scores indicating better quality of life) in the weight loss arm before and after weight loss intervention.
Measured: 1 year
Abdominal wall -specific quality of life short-term
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Measured: 30 days
Pain scores
This includes the difference in pain scores using the PROMIS 3a Pain Intensity Score (scored from 30.7-71.8) at baseline, 30-day, and 1 year.
Measured: 1 year
Cost effective analysis
Perform a formal cost effectiveness analysis.
Measured: 1 year
Body weight percentage loss
Proportion of patients achieving a reduction in 5% and 10% body weight at end of 6-month medical weight loss intervention, day of surgery, and 1-year follow-up
Measured: 1 year
Weight management program adherence
Proportion of successful completion of the program (defined as attending at least 4 visits) is associated with lower wound complications, hernia recurrence, or higher HerQLes score at one year
Measured: 1 year
Impact of 10% body weight loss on wound complications
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare proportion of wound complications
Measured: 1 year
Impact of 10% body weight loss on hernia recurrence
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare hernia recurrence at one year
Measured: 1 year
Impact of 10% body weight loss
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare HerQLes score (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year
Measured: 1 year
Urgent repair
Number of patients who require urgent hernia repair in either arm
Measured: 1 year
Bariatric surgery prior to hernia repair and wounds
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of wound complications at one year
Measured: 1 year
Bariatric surgery prior to hernia repair and hernia recurrence
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of hernia recurrence at one year
Measured: 1 year
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair and HerQLes scores (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start19 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin T. Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin T. Miller, The Cleveland Clinic
- Investigators
- Benjamin T Miller, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925959
- Sponsor's protocol ID
- 23-418
- Status last verified
- Oct 2025
- First submitted
- 14 Jun 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Remulla D, Miles KS, Carvalho A, Maskal SM, Butsch WS, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Rosen MJ, Miller BT. Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial. Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y.
PubMed 40434485
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Weight Loss for Open Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT05925959
- Acronym / sponsor ID
- 23-418
- Conditions
- Abdominal Wall Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Benjamin T. MillerUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
Detailed description
This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Surgery | No intervention | – |
| Preoperative Weight Management Program | Active comparator | Other: Preoperative Weight Management Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Lack of English language fluency
- Urgent need for repair as determined by surgeon judgement
- Pregnant patients
- Permanent stoma in place
- Isolated flank hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Weight Management ProgramThe medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days. | Other | Preoperative Weight Management Program |
Primary outcome
Abdominal core health-specific quality of life at 1 year
Time frame: 1 year
This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life.
20 secondary outcomes
Hernia recurrence at 1 year
Time frame: 1 year
Wound morbidity at 30 days
Time frame: 30 days
Wound morbidity at 1 year
Time frame: 1 year
Body composition changes in weight
Time frame: 1 year
Body composition changes in BMI
Time frame: 1 year
Patient abdominal wall specific- quality of life with preoperative weight management program
Time frame: 1 year
Patient-reported pain changes with preoperative weight management program
Time frame: 1 year
Patient-reported quality of life changes with preoperative weight management program
Time frame: 1 year
Abdominal wall -specific quality of life short-term
Time frame: 30 days
Pain scores
Time frame: 1 year
Cost effective analysis
Time frame: 1 year
Body weight percentage loss
Time frame: 1 year
Weight management program adherence
Time frame: 1 year
Impact of 10% body weight loss on wound complications
Time frame: 1 year
Impact of 10% body weight loss on hernia recurrence
Time frame: 1 year
Impact of 10% body weight loss
Time frame: 1 year
Urgent repair
Time frame: 1 year
Bariatric surgery prior to hernia repair and wounds
Time frame: 1 year
Bariatric surgery prior to hernia repair and hernia recurrence
Time frame: 1 year
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 40434485Remulla D, Miles KS, Carvalho A, Maskal SM, Butsch WS, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Rosen MJ, Miller BT. Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial. Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin T Miller, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Weight Management Program in people with Abdominal Wall Hernia, run by Benjamin T. Miller at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin T Miller, MD (216 406-8573, millerb35@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal core health-specific quality of life at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.