SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Free radical scavengers versus methylprednisolone in the prevention of experimentally induced heterotopic ossification.

The etiology of heterotopic ossification (HO) is still obscure, it is difficult to devise an effective preventive or therapeutic approach. The options for the prevention of HO are still limited. The prophylactic effect of nonsteroidal anti-inflammatory drugs (NSAIDs) is insufficient. Moreover, NSAIDs increase the risk of nonunion and loosening in patients with multiple joint injuries. The present experimental study was designed to compare methylprednisolone with free radical scavengers for the prevention of HO. The model of Michelsson et al. was used to induce HO in the hind legs of 30 female New Zealand albino rabbits, weighing approx. 4 kg. The animals were randomized into three groups of 10 animals each, and received daily either placebo, a free radical scavenger cocktail [allopurinol and N-acetylcysteine (A/A)], or methylprednisolone in a randomized, double-blind fashion. Every four days, X-rays were obtained to measure the thickness and the length of new bone formation at the thigh. A statistically significant difference in thickness and length of newly formed bone was found between the three groups. In the placebo group HO increased from day 16 toward a medium length of 6 mm and a median thickness of 1.5 mm. In the A/A group, no signs of HO were found. In the methylprednisolone group, only one animal presented minor HO from day 32. Both free radical scavengers and methylprednisolone were found to inhibit HO, and may be considered effective measures for the prevention of heterotopic bone formation. However, it could not be demonstrated which of the two had the strongest inhibitory effect.

Shoulder function after harvesting a thoracodorsal artery perforator flap.

BACKGROUND: Converting the latissimus dorsi musculocutaneous flap to a thoracodorsal artery perforator flap has been reported for breast reconstruction. The goal of this article is to evaluate the donor site after harvesting a thoracodorsal artery perforator flap in patients who underwent breast surgery and to show the advantages of sparing the latissimus dorsi muscle on the function of the shoulder. METHODS: Between 2002 and 2004, 22 patients who had a partial breast reconstruction using a pedicled thoracodorsal artery perforator flap were enrolled in a functional study to evaluate shoulder function postoperatively. Latissimus dorsi muscle strength, shoulder mobility, and latissimus dorsi thickness were measured by using the MicroFet2, a goniometer, and ultrasound examination, respectively. The measurements of the operated and contralateral (unoperated) sides were analyzed statistically. RESULTS: When comparing the operated sides to the unoperated sides, latissimus dorsi strength seemed to be maintained after surgery. Shoulder mobility was also similar in all movements, but both active and passive forward elevation and passive abduction were reduced significantly after surgery, and latissimus dorsi thickness was not affected by harvesting the thoracodorsal artery perforator flaps. No seroma formation was found in any of the donor sites. CONCLUSIONS: Donor-site morbidity after harvesting a thoracodorsal artery perforator flap was reduced to a minimum. Therefore, perforator flaps should be considered in reconstruction whenever adequate perforators can be identified and safely dissected.