Physical and mental health of breast cancer patients and survivors before and during successive SARS-CoV-2-infection waves.

PURPOSE: During the first SARS-CoV-2-infection wave, a deterioration in emotional well-being and increased need for mental health care were observed among patients treated or being treated for breast cancer. In this follow-up study, we assessed patient-reported quality of life (QoL), physical functioning, and psychosocial well-being during the second SARS-CoV-2-infection wave in a large, representative cohort. METHODS: This longitudinal cohort study was conducted within the prospective, multicenter UMBRELLA breast cancer cohort. To assess patient-reported QoL, physical functioning and psychosocial well-being, COVID-19-specific surveys were completed by patients during the first and second SARS-CoV-2-infection waves (April and November 2020, respectively). An identical survey was completed by a comparable reference population during the second SARS-CoV-2-infection waves. All surveys included the validated EORTC-QLQ-C30/BR23, HADS and "De Jong-Gierveld Loneliness" questionnaires. Pre-COVID-19 EORTC-QLQ-C30/BR23 and HADS outcomes were available from UMBRELLA. Response rates were 69.3% (n = 1106/1595) during the first SARS-CoV-2-infection wave and 50.9% (n = 822/1614) during the second wave. A total of 696 patients responded during both SARS-CoV-2-infection waves and were included in the analysis comparing patient-reported outcomes (PROs) during the second SARS-CoV-2-infection wave to PROs during the first wave. Moreover, PROs reported by all patients during the second SARS-CoV-2-infection wave (n = 822) were compared to PROs of a similar non-cancer reference population (n = 241) and to their pre-COVID-19 PROs. RESULTS: Patient-reported QoL, physical functioning, and psychosocial well-being of patients treated or being treated for breast cancer remained stable or improved from the first to the second SARS-CoV-2-infection wave. The proportion of emotional loneliness reduced from 37.6 to 29.9% of patients. Compared to a similar non-cancer reference population, physical, emotional, and cognitive functioning, future perspectives and symptoms of dyspnea and insomnia were worse in patients treated or being treated for breast cancer during the second SARS-CoV-2-infection wave. PROs in the second wave were similar to pre-COVID-19 PROs. CONCLUSION: Although patients scored overall worse than individuals without breast cancer, QoL, physical functioning, and psychosocial well-being did not deteriorate between the first and second wave. During the second wave, PROs were similar to pre-COVID-19 values. Overall, current findings are cautiously reassuring for future mental health of patients treated or being treated for breast cancer.

Influence of previous laparo-endoscopic inguinal hernia repair on performing radical prostatectomy: a nationwide survey among urological surgeons.

BACKGROUND: There is considerable demographic overlap of inguinal hernia patients and prostate cancer patients. Previous laparo-endoscopic inguinal hernia mesh repairs can complicate subsequent radical prostatectomies due to adhesions and distortion of anatomic planes. This study aims to assess the experience of urological surgeons on the safety and feasibility of performing radical prostatectomies after laparo-endoscopic inguinal hernia mesh repair. METHODS: For this cross-sectional study, an online 24 question survey was developed regarding the experience in performing a radical prostatectomy and pelvic lymph node dissection (PLND) with a prior preperitoneal inguinal hernia mesh repair. Between June 2016 and December 2017, the questionnaire was sent to all 68 urological surgeons performing radical prostatectomy in the Netherlands. RESULTS: The response rate of urological surgeons was 69% (n = 47). The majority (77%) of urological surgeons perform robot-assisted laparoscopic prostatectomies. A previous preperitoneal inguinal hernia repair was reported by 40% of urological surgeons in 10-30% of patients undergoing radical prostatectomy. Radical prostatectomy with prior preperitoneal inguinal hernia mesh repair is considered more difficult by 49%, predominantly because of (occasionally to always) experienced longer operating times (88.4%), increased blood loss (46.5%), difficult dissection of Retzius space (88.4%), nerve-sparing difficulties (32.6%), less adequate PLND (69.8%), and bladder- (16.3%) or peritoneal perforations (27.9%). Additionally, 11.6% had performed mesh explantation, 16.3% had aborted radical prostatectomies, and 35.7% experienced increased inguinal hernia recurrences after radical prostatectomies with prior preperitoneal inguinal hernia mesh repair. More experienced urological surgeons reported an increased difficulty for all outcomes. CONCLUSIONS: Laparo-endoscopic inguinal hernia mesh repair has a significant impact on performing a radical prostatectomy and PLND. Surgeons should postpone the inguinal hernia repair of patients in the workup for a radical prostatectomy, with the preferable option of performing the radical prostatectomy and inguinal hernia repair in the same procedure. Alternatively, a Lichtenstein repair can be performed.

Heavyweight Mesh Is Superior to Lightweight Mesh in Laparo-endoscopic Inguinal Hernia Repair: A Meta-analysis and Trial Sequential Analysis of Randomized Controlled Trials.

OBJECTIVE: This meta-analysis and trial sequential analysis aims to provide an update on the available randomized controlled trials (RCTs) and recommendations on using lightweight mesh (LWM) or heavyweight mesh (HWM) in laparo-endoscopic inguinal hernia repair. BACKGROUND: LWM might reduce chronic pain through improved mesh flexibility and less fibrosis formation. However, in laparo-endoscopic repair chronic pain is already rare and LWM raise concerns of higher recurrence rates. METHODS: A literature search was conducted in May 2019 in MEDLINE, Embase, and the Cochrane library for RCTs that compared lightweight (≤50 g/m2) and heavyweight (>70 g/m2) mesh in patients undergoing laparo-endoscopic surgery for uncomplicated inguinal hernias. Outcomes were recurrences, chronic pain, and foreign-body sensation. The level of evidence was assessed using GRADE. Risk ratios (RR) and 95% confidence intervals (CI) were calculated by random effect meta-analyses. Trial-sequential-analyses were subsequently performed. RESULTS: Twelve RCTs, encompassing 2909 patients (LWM 1490 vs HWM 1419), were included. The follow-up range was 3 to 60 months. Using LWM increased the recurrence risk (LWM 32/1571, HWM 13/1508; RR 2.21; CI 1.14-4.31), especially in nonfixated mesh direct repairs (LWM 13/180, HWM 1/171; RR 7.27; CI 1.33-39.73) and/or large hernia defects. No difference was determined regarding any pain (LWM 123/1362, HWM 127/1277; RR 0.79; CI 0.52-1.20), severe pain (LWM 3/1226, HWM 9/1079; RR 0.38; CI 0.11-1.35), and foreign-body sensation (LWM 100/1074, HWM 103/913; RR 0.94; CI 0.73-1.20). CONCLUSION: HWM should be used in laparo-endoscopic repairs of direct or large inguinal hernias to reduce recurrence rates. LWM provide no benefit in indirect hernias.

Lightweight mesh is recommended in open inguinal (Lichtenstein) hernia repair: A systematic review and meta-analysis.

BACKGROUND: The use of lightweight mesh for inguinal hernia repair has been suggested to be preferable compared with heavyweight mesh. Nevertheless, surgeons do not use lightweight mesh routinely, possibly owing to the higher price and lack of confidence in evaluation of previous evidence. The aim of this systematic review and meta-analysis is to update the available randomized controlled trials and provide a recommendation on the use of lightweight mesh or heavyweight mesh in open inguinal hernia repair. METHODS: A literature search was conducted in May 2019 in MEDLINE, Embase and the Cochrane library for randomized controlled trials comparing lightweight (≤50 g/m2) and heavyweight (>70 g/m2) mesh in patients undergoing open (Lichtenstein) surgery for uncomplicated inguinal hernias. Outcomes were recurrences (overall, after direct or indirect repair), chronic pain (analyzing any and severe pain), and the feeling of a foreign body. The level of evidence was assessed using GRADE. Risk ratios and 95% confidence intervals were calculated by random effect meta-analyses. RESULTS: Twenty-one randomized controlled trials involving 4,576 patients (lightweight mesh 2,257 vs heavyweight mesh 2,319) were included. Follow-up ranged from 3 to 60 months. No difference between lightweight mesh and heavyweight mesh was determined for recurrence rates (lightweight mesh 42 of 2,068 and heavyweight mesh 34 of 2,132; risk ratios 1.22; 95% confidence interval, 0.76-1.96) or severe pain (lightweight mesh 14 of 1,517 and heavyweight mesh 26 of 1,591; risk ratios 0.73; 95% confidence interval, 0.38-1.41). A significant reduction was seen for any pain after lightweight mesh (234 of 1,603) compared with heavyweight mesh (322 of 1,683; risk ratios 0.78; 95% confidence interval, 0.64-0.96) and for the feeling of a foreign body (lightweight mesh 130 of 1,053 and heavyweight mesh 209 of 1,035; risk ratios 0.64; 95% confidence interval, 0.51-0.80). CONCLUSION: Lightweight mesh should be used in open (Lichtenstein) inguinal hernia repair.

Regional Recurrence Risk Following a Negative Sentinel Node Procedure Does Not Approximate the False-Negative Rate of the Sentinel Node Procedure in Breast Cancer Patients Not Receiving Radiotherapy or Systemic Treatment.

BACKGROUND: Although the false-negative rate of the sentinel lymph node biopsy (SLNB) in breast cancer patients is 5-7%, reported regional recurrence (RR) rates after negative SLNB are much lower. Adjuvant treatment modalities probably contribute to this discrepancy. This study assessed the 5-year RR risk after a negative SLNB in the subset of patients who underwent breast amputation without radiotherapy or any adjuvant treatment. METHODS: All patients operated for primary unilateral invasive breast cancer between 2005 and 2008 were identified in the Netherlands Cancer Registry. Patients with a negative SLNB who underwent breast amputation and who were not treated with axillary lymph node dissection, radiotherapy, or any adjuvant systemic treatment were selected. The cumulative 5-year RR rate was estimated by Kaplan-Meier analysis. RESULTS: A total of 13,452 patients were surgically treated for primary breast cancer and had a negative SLNB, and 2012 patients fulfilled the selection criteria. Thirty-eight RRs occurred during follow-up. Multifocal disease was associated with a higher risk of developing RR (P = 0.04). The median time to RR was 27 months and was significantly shorter in patients with estrogen receptor-negative (ER-) breast cancer (9.5 months; P = 0.003). The 5-year RR rate was 2.4% in the study population compared with 1.1% in the remainder of 11,440 SLNB-negative patients (P = 0.0002). CONCLUSIONS: Excluding the effect of radiotherapy and systemic treatment resulted in a twofold 5-year RR risk in breast cancer patients with a tumor-free SLNB. This 5-year RR rate was still much lower than the reported false-negative rate of the SLNB procedure.

Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial.

BACKGROUND: Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain. The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia. METHODS: The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year. DISCUSSION: This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved. TRIAL REGISTRATION: The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry ( NTR6835 ) registered on November 13, 2017.

Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial).

OBJECTIVE: The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair. BACKGROUND: Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates. METHODS: Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores. RESULTS: During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4-10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected. CONCLUSIONS: In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.