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Not yet recruitingNCT07699913RM BREAST QUpdated Jul 15, 2026

Quality of Life of Patients Who Have Undergone Bilateral Mastectomy

An observational study in Surgery Date, Age and BMI, sponsored by University Hospital, Grenoble. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Primary conditionPostoperative ComplicationsRegistry: Body WeightReclassifiedWhy we changed it
Registry
Body Weight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Postoperative Complications
Why
  1. Body Weight is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Postoperative Complications.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Grenoble · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
115
Ages
18 Years and older
Sex
Female
01

Study summary

The investigators therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have undergone bilateral mastectomy. The goal of this observational study is thus to measure and compare the quality of life of patients who have undergone bilateral mastectomy using the BREAST-Q questionnaire.

02

Conditions studied

  • Surgery Date
  • Age
  • BMI
  • Height
  • Weight
  • Smoking Status
  • Hormone Therapy
  • Chemotherapy
  • Radiotherapy
  • Postoperative Complications
  • Type of Reconstruction (Flap or Implant)
  • Timing of Reconstruction
  • Type of Mastectomy (Prophylactic or Therapeutic)
  • BRCA Mutation

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Keywords

  • Comparative
  • observational
  • retrospective
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In context

Postoperative Complications Reclassified

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's planned enrollment of 115 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Compared within Postoperative Complications, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated at CHU Grenoble Alpes for bilateral breast reconstruction between January 1, 2015, and January 1, 2026, in the plastic surgery and gynecology departments (departments performing breast reconstruction procedures).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female sex
  • Age ≥ 18 years
  • Bilateral mastectomy
  • Breast reconstruction between January 1, 2015, and January 1, 2026
  • No objection to the study

Exclusion criteria

Exclusion Criteria:

  • Individual under guardianship or curatorship, or deprived of liberty
  • Reconstruction not completed by January 1, 2026.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
115 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bilateral prophylactic mastectomy

    The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy

  • Bilateral therapeutic mastectomy

    The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy

  • Therapeutic and prophylactic mastectomy

    The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy

06

What researchers measure

Primary outcomes

  1. Measure of the BREAST Q Questionnaire

    Composite score on the standardized BREAST-Q questionnaire for the following domains: psychosocial well-being, sexual well-being, physical well-being, and breast satisfaction, starting at 3 months postoperatively. A conversion table allows for conversion of the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

    Time frame: 3 months post operatively

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Jul 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 13, 2026
StartEst.
Jul 10, 2026
Primary completionEst.
Jul 30, 2026
CompletionEst.
Aug 20, 2026
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07699913
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Jul 10, 2026 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Aug 20, 2026 (estimated)
Last update
Jul 15, 2026

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 not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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