What is the comparative perioperative (<6 months) and long-term (>6 months) safety profile of tissue-expander/implant reconstruction versus abdominal flap breast reconstruction in female, breast-cancer patients following mastectomy?

What is the profile of the patient-reported outcomes, with respect to patient assessed quality of life and satisfaction, following tissue-expander/implant reconstruction compared to the abdominal flap breast reconstruction?

What is the economic value of breast reconstruction between the tissue expander/implant reconstruction compared to abdominal flap breast reconstruction?

The following databases will be searched for relevant studies from 2000 to the present:

• OVID Embase

• NLM Pubmed

• Cochrane Database of Systematic Reviews (CDSR )

• Cochrane Central Register of Controlled Trials (CENTRAL)

• ProQuest Dissertation Pub

• Database of Abstracts of Reviews of Effects (DARE)

• Health Technology Assessment Database (HTA)

• NHS Economic Evaluation Database (NHS EED)

• Canadian Agency for Drugs and Technologies in Health (CADTH) Health Technology Assessment

In addition, the references of relevant systematic reviews will be reviewed to identify any additional, relevant items.

Types of study will include:

• Randomised controlled trials

• Non-randomised (i.e. observational) comparative studies (sample size n=>10)

• Economic evaluations

Despite the recent surgical advances for patients with breast cancer, many patients will still undergo total mastectomy (as compared to lumpectomy and radiotherapy). The loss of the breast mound can be a traumatic experience with significant long-term quality of life impact. As such, a potential solution is reconstructive surgery. The goal of reconstruction is to recreate the breast mound and restore the patient’s quality of life without affecting the prognosis or detection of cancer recurrence. This reconstructive procedure has been suggested to provide both functional and psychosocial benefits and may improve patient satisfaction following mastectomy.

There are two primary methods of reconstruction: (i) alloplastic and (ii) autogenous tissue reconstruction. In particular, the tissue-expander/ implant reconstruction is the most commonly practiced alloplastic reconstructive procedure in the U.S. and has become increasingly popular in Canada as an alternative to autogenous tissue reconstruction, the most common type, being an abdominal tissue based flap. The tissue-expander/implant reconstruction method is a two-staged procedure which involves placing an uninflated expander beneath the skin and muscle of the mastectomy scar and is inflated intermittently once the tissue surrounding the breast has recovered from the surgery. Once the expander has been inflated to its desired volume, the breast tissues is allowed to relax and adjust to its new position before a second surgery occurs to exchange the expander with an appropriate permanent implant.

The purpose of this review will be to comparatively evaluate the safety, patient-reported outcomes and cost-effectiveness between the tissue-expander/implant and the abdominal flap reconstruction procedure in breast-cancer patients following mastectomy.

Female breast cancer patients who are undergoing immediate or delayed breast reconstruction following mastectomy, with or without chemotherapy and/or radiotherapy.

Tissue-expander/ implant

Abdominal flap breast reconstruction, which includes: deep inferior epigastric perforators flap (DIEP), superficial inferior epigastric artery flap (SIEA), transverse rectus abdominus myocutaneous flap (TRAM; free or pedicled).

Primary outcomes

The safety outcomes for consideration include the occurrence rate (and odds ratio, relative risk or difference in proportion, as applicable) for the following complications:

• Capsular contracture

• Necrosis of skin

• Infection

• Seroma/ hematoma

• Abdominal bulge

• Flap failure

• Number of reoperations

• Cancer recurrence

• Mortality

• Other complications reported

• Total number of patients with >1 complication

The clinical outcomes for consideration will be patient-reported outcomes that include quality of life, pain, psychosocial, satisfaction and functional status.

The economic outcomes for consideration will be incremental cost for incremental benefit (i.e. cost-effectiveness). Furthermore, we would collect any details reporting medical resource utilization such as the number of hospital days for each procedure.

Secondary outcomes

None

Two reviewers will independently screen the titles and abstracts of all reports identified by the literature searches using pre-defined inclusion/exclusion criteria. Discrepancies will be resolved by discussion, with the involvement of a third reviewer if necessary. Full copies of all studies deemed potentially relevant will be obtained and two reviewers will independently assess these for inclusion. Similarly, any disagreements will be resolved by consensus or discussion with a third reviewer.

Data extraction will be done using a piloted and standardized data abstraction form by two independent reviewers. The following data will be collected: study details/design, participants, intervention and comparator, risk factors (e.g. radiation therapy, chemotherapy, smoking status, diabetes), study quality, and outcome measures.. Any disagreements will be resolved by consensus or discussion with a third reviewer.

The adequacy of reporting of the qualifying studies will be assessed using standard tools appropriate to their study designs; with assessment carried out following the CONSORT guidelines for RCT and STROBE guidelines for observational studies.

All quality assessment will be carried out independently by two reviewers with disagreements resolved by consensus. The results from the quality assessment will be used primarily for descriptive purposes to provide an evaluation on the overall quality of the included studies and to provide a transparent method of recommendation for design of any future studies.

The methods of data synthesis will be determined by the nature of the studies identified through searches and included in this review.

Data on the variable being studied will be pooled and stratified by study design. Where heterogeneity is not significant, quantitative data synthesis by meta- analysis will be carried out assuming a random effects model. Otherwise, the main method of analysis will be narrative synthesis with the results tabulated, with conclusions based on patterns of results across all included studies clearly presented in tables.

Careful account will be taken of issues of generalisability and study quality.

None planned

This systematic review will be published in a reputable peer-reviewed journal and presented at local and international conferences.

Bernice Tsoi

25 Main Street West, Suite 2000

Hamilton, Ontario L8P 1H1 Canada

tsoib@mcmaster.ca

Programs for Assessment of Technology in Health (PATH) Research Institute

http://www.path-hta.ca

Ms Bernice Tsoi, Programs for Assessment of Technology in Health (PATH) Research Institute
Ms Natalia Ziolkowski, Medical University of Warsaw
Dr Achilleas Thoma, Department of Surgery, McMaster University
Professor Kaitryn Campbell, Programs for Assessment of Technology in Health (PATH) Research Institute
Dr Daria O'Reilly, Programs for Assessment of Technology in Health (PATH) Research Institute
Professor Ron Goeree, Programs for Assessment of Technology in Health (PATH) Research Institute

12 September 2012

31 March 2013

None

None known

English

Canada, Poland

Subject indexing assigned by CRD

Breast Implants; Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Surgical Flaps;

04 October 2012

20 February 2013