Clinical trial NCT03838549: Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Official title: Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Genetic Predisposition
Breast Cancer
Keywords: Prophylactic Surgical Procedure
Subcutaneous Mastectomy
Endoscopy
Breast Reconstruction
Breast Implants
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Association la Montpellier Reine a du Cœur
First posted: 2019-02-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

Detailed description: It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
* Ask an immediate breast reconstruction during the surgery
* World Heath Organization score \<3
* Glandular volume : french bra cup size A, B ou C
* Glandular ptosis \<=2 (Classification and Algorithm for Treatment of Breast Ptosis)
* Contraception for woman of childbearing age and no pregnancy
* Valid Social Security
* Wrote consent

Exclusion Criteria:

* History of breast cancer surgery
* Breast cancer not operated on the side concerned by the prophylactic mastectomy
* Patient having had irradiant treatment
* Breast hypertrophy
* Smoking \> 10 cigarette/day
* Body Mass Index \> 30
* Large breast volume requiring prostheses \> 500ml
* Chronic pulmonary obstructive gold 4
* ASA (Physical Status score of American Society of Anesthesiologists) \> 3
* Chronic shoulder pain on the side to operate, or both shoulders
* History of abarticular pathology of the shoulder on the operating side
* Patient involvment in another clinical research
* Protected patient or unable to give consent
* Pregnant or breastfeeding woman
* Vulnerable person (Article L1121-6 of the Public Health Code)

Primary outcomes:
measure: success rate of total mastectomy
timeFrame: one day
Secondary outcomes:
measure: Operative time
timeFrame: one day
measure: Open surgery conversion rate
timeFrame: one day
measure: Number of participants with an infection
timeFrame: 1 and 3 months after the prophylactic mastectomy
measure: Blood loss
timeFrame: one day
measure: Number of participants with a local haematoma
timeFrame: Between the day of the prophylactic mastectomy and a month later
measure: Disunity of the scar
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Exposure of the prosthesis
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Post-operative seromas after the prophylactic mastectomy
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Complication rate of subcutaneous insufflation
timeFrame: 3 and 12 months after the prophylactic mastectomy
measure: Skin case necrosis
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Necrosis of areolo-nipple plaque
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Analogue visual scale (EVA)
timeFrame: 1, 3, 6 and 12 months after the prophylactic mastectomy
measure: Hospital stay
timeFrame: Through discharge from hospitalization, an average of 7 days
measure: Aesthetic result
timeFrame: 3 and 12 months after the prophylactic mastectomy
measure: Need for cosmetic reoperation
timeFrame: 3 and 12 months after the prophylactic mastectomy
measure: Shoulder function
timeFrame: 3 months after the prophylactic mastectomy
measure: Life quality
timeFrame: 3 and 12 months after the prophylactic mastectomy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
state: Hérault
Study officials:
References:
citation: Rathat G, Blay L, Bakenga J, Roggen N, Peralta G, Baekelandt J. Scarless preventive surgery. Int J Gynaecol Obstet. 2023 Nov;163(2):701-702. doi: 10.1002/ijgo.15039. Epub 2023 Aug 7. No abstract available.
citation: Rathat G, Fontaine V, Chaumette M, Duraes M. [How I do... an endoscopic mastectomy in 10 steps]. Gynecol Obstet Fertil Senol. 2024 Nov;52(11):653-656. doi: 10.1016/j.gofs.2024.05.004. Epub 2024 May 29. No abstract available. French.