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WithdrawnNCT04805424Updated Mar 10, 2023

Techniques for Abdominoplasty After Massive Weight Loss

An interventional study of Lipo-abdominoplasty and Abdominoplasty in Skin; Excess, sponsored by Karolinska University Hospital. Withdrawn at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Karolinska University Hospital unable to support the clinical trial as anticipated.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.

The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.

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Conditions studied

  • Skin; Excess

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Keywords

  • Randomized controlled trial
  • Abdominoplasty
  • Massive weight loss
  • Plastic surgery
  • Liposuction
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

Browse Weight Loss studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

This study is open only to individuals who are residents in Sweden and qualify for government-funded, inpatient, non-emergency health care within the Stockholm Region.

Inclusion criteria

Inclusion Criteria:

  • BMI \< 30
  • Stable BMI for >= 6 months
  • >= 24 months since bariatric surgery, if applicable
  • Skin fold of >= 5 cm
  • Functional and/or psychosocial issues due to abdominal skin excess

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Ongoing infection
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Abdominoplasty

    Standard abdominoplasty

    Procedure: Abdominoplasty

  • Experimental
    Lipo-abdominoplasty

    Abdominoplasty plus liposuction

    Procedure: Lipo-abdominoplasty

Interventions

  • ProcedureLipo-abdominoplasty

    Abdominoplasty plus liposuction

  • ProcedureAbdominoplasty

    Abdominoplasty

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What researchers measure

Primary outcomes

  1. Number of and type of complications within 30 days

    Number of and type of complications occurring within 30 days of surgery

    Time frame: 30 days

Secondary outcomes

  1. Average need for analgesia in morphine equivalents

    Average need for analgesia in morphine equivalents during post-operative day 1

    Time frame: Post-operative day 1

  2. Average score on BodyQ score

    Average score on BodyQ score including subscales. BodyQ is developed and owned by Memorial Sloan Kettering Cancer Center. The BODY-Q is composed of 27 independently functioning scales that measure 3 overarching constructs Appearance, Quality of Life and Experience of Care. Scales are translated to a 0-100 score where a lower score means worse outcome.

    Time frame: At baseline, at 3 months post-operatively, at 12 months post-operatively

  3. Average score on aesthetic result

    Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome.

    Time frame: At 12 months post-operatively

  4. Average days until discharge

    Average days until discharge post-operatively

    Time frame: Days

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Study locations

1 site
  • Reconstructive Plastic Surgery, Karolinska University Hospital
    Stockholm, 171 76, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04805424
Lead sponsor
Karolinska University Hospital
Responsible party
Ebba Lindqvist (Principal Investigator, Karolinska University Hospital) — Principal investigator
First posted
Mar 18, 2021
Start date
Jan 2023 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Mar 10, 2023

Study contacts

Ebba Lindqvist, MD, PhD
principal investigator · Karolinska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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