An interventional study of Fascia pectoralis preservation in BRCA1/2 Mutation, Bilateral Prophylactic Mastectomy and Seroma, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.
The primary objective of this pilot study is to investigate the impact of removal versus preservation of the pectoral fascia on drain policy and needle aspirations in women who undergo a bilateral prophylactic mastectomy. The secondary objective is to investigate the impact of removal versus preservation of the pectoral fascia on postoperative (surgical) complications.
The study design includes a double-blinded, prospective, randomized controlled pilot study with a within-subject design. All patients will undergo a bilateral prophylactic mastectomy and randomization will occur within the patient. Preservation of the PF will be performed in one breast (intervention), while removal of the PF will be performed in the contralateral breast of the same patient (control). Consequently, the operation involves a total bilateral prophylactic mastectomy, with unilateral preservation of the PF
The follow-up time of each patient will be 6 weeks. The patients' files will be viewed after the removal of the drain for additional recorded variables.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 21 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Fascia pectoralis preservation
Procedure: Fascia pectoralis preservation
A total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery.
Drainproduction in milliliters
The total drainage volume of the left and right breast in milliliters
Time frame: Until drain removal, maximum 1 week
Time to drain removal in days
Number of days until drain removed
Time frame: Until drain removal, maximum 1 week
Seroma (yes/no)
Occurrence of seroma
Time frame: Up to 6 weeks
Needle aspirations (number)
Number of needle aspirations
Time frame: Up to 6 weeks
Postoperative pain (score 1-10)
Postoperative pain measured with Visual Analogue Scale
Time frame: Up to 6 weeks
Postoperative bleeding (yes/no)
Occurrence of postoperative bleeding
Time frame: Up to 6 weeks
Wound related issues (yes/no)
Wound related issues such as hematoma or infection
Time frame: Up to 6 weeks
Hospitalization duration (in days)
Duration of hospitalization, including readmissions
Time frame: Up to 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2023, 23 months after the start.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 23 months is below that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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