open access - BMC Cancer Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study (protocol/design/Netherlands)

Study protocol

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

BMC Cancer 2012, 12:31 doi:10.1186/1471-2407-12-31
Published: 20 January 2012

Abstract (provisional)

Background

Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful PDS for ovarian cancer.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

no abstract: Is comprehensive surgical staging needed for thorough evaluation of early stage ovarian carcinoma? (Journal Club article for discussion March 2012

Blogger's Note: requires subscription ($$$)
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references original article:

Is comprehensive surgical staging needed for thorough evaluation of early-stage ovarian carcinoma?

• Conclusion

  Patients with epithelial ovarian cancer should continue to undergo comprehensive surgical staging, since it identifies occult metastasis in a significant number of patients.

   Available online 22 August 2011.

US Deaths Resulting From Inpatient Surgery Decline

 "January 18, 2012 — The number of surgical procedures performed in the United States increased between 1996 and 2006, whereas inpatient postsurgical deaths within 30 days of admission dropped significantly, according to a national, population-level analysis published  (abstract) in the February issue of Surgery....."

".....In 2006, more patients had sepsis or pneumonia than in 1996, and the absolute number of deaths resulting from complications increased. However, the failure-to-rescue rate declined during the study period for both groups (sepsis, from 18.69% to 14.03%; pneumonia, from 8.54% to 7.34%). Meanwhile, the number of deaths resulting from deep venous thrombosis or pulmonary embolism, upper gastrointestinal bleeding, and shock declined during the study period.
Overall, the number of patients with 1 to 5 complications increased, but the failure-to-rescue rate for patients with an identified complication decreased from 12.10% to 9.84% (P < .001)
"The decline in the number of deaths may have occurred through reduced mortality of individual procedures, reductions in the volume of high-risk procedures, and the rescue of patients who had a complication," the authors write.
They estimate that 51,000 fewer people died in 2006 than would have with the 1996 mortality rate. However, they also note that some portion of the decline in mortality "may represent the effect of premature discharge as opposed to an actual improvement in survival." Data were not linked across admissions, and a patient discharged postoperatively who was later readmitted with a complication and died would not be counted as a death in this study."

Comment on "Training Surgeons and the Informed Consent Process: Routine Disclosure of Trainee Participation and Its Effect on Patient Willingness and Consent Rates"

abstract: Re-operation outcome in patients referred to a gynecologic oncology center with presumed ovarian cancer FIGO I-IIIA after sub-standard initial surgery

Blogger's Note: 

1)  this issue is not a new issue irrespective of country origin

2)  it would be helpful if a timely comprehensive study be done (retrospective) on the fatality rates, stage and pathology, and  according to surgeon/upstaging required via eg. national registries albeit the data bases most likely are lacking; until mandates are in place requiring specific surgical skills in surgical oncology these practices will continue (past and future decades)

 Abstract  

Background

Surgery is the mainstay of treatment for early ovarian cancer both as therapeutic and comprehensive staging. Only the latter allows appropriate tailoring of systemic treatment. However, the compliance with guidelines for comprehensive staging has been reported to be only moderate and, therefore, re-staging procedures are commonly indicated to avoid undertreatment. The purpose of our study was to evaluate re-operation (2nd surgery) in a tertiary gynecologic oncology unit after primary operation for presumably ovarian cancer FIGO I-IIIA in general gynecology departments. Only 5 patients (13%) were classified as having had a comprehensive staging by surgical records and pathology reports and 35 patients underwent comprehensive re-staging laparotomy after which 20 patients (50%) experienced an upstaging including 13 patients with final diagnosis of FIGO stage IIIC.

Results

40 patients were enrolled of whom 53% came by self-referral. Only 18% were referred by the primary surgeon and the remaining patients were referred by their home gynecologist..........

Conclusion

Comprehensive staging of presumed early ovarian cancer has been described as major problem especially outside gynecologic oncology units. Re-staging results in our department confirmed this deficiency by showing a considerable proportion of upstaging associated with alterations of recommendations for systemic treatment. However, series like this may even underestimate the problem, because incomplete staging is unfortunately accompanied by non-systematic referral practices not reflecting staging quality.

Impact of surgeon volume on patient safety in laparoscopic gynecologic surgery: Gynecologic Oncology

Highlights

► Low volume surgeons experience increased perioperative laparoscopic complications
► Outcomes are improved in patients treated by medium and high-volume surgeons

Quality control in ovarian cancer surgery

If the profession does not institute adequate internal regulation of the quality of ovarian cancer surgery, regulation is likely to be imposed by government.

Factors Associated with Altered Long-Term Well-Being After Prophylactic Salpingo-Oophorectomy Among Women at Increased Hereditary Risk for Breast and Ovarian Cancer

Blogger's note: full view may require $$$ (subscription)

link to abstract

An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT)

abstract: Lymphadenectomy in ovarian cancer: standard of care or unne... : Current Opinion in Oncology

Abstract

Purpose of review: The clinical significance of lymphadenectomy in ovarian cancer is controversial. In early ovarian cancer (EOC), it is the extent of the procedure that is the main focus of debate. In advanced disease [advanced ovarian cancer (AOC)], the issue is whether or not lymphadenectomy independently impacts survival. This review summarizes the current standard of care as it relates to the role of lymphadenectomy in ovarian cancer.

Recent findings: Lymphadenectomy in EOC is a diagnostic procedure in as much as it is an integral and mandatory part of a complete surgical staging. The required extent of the procedure, however, remains uncertain. It has been suggested that at least 10 nodes from different, predefined retroperitoneal sites should be the minimum number removed. Lymphadenectomy in AOC is of potential therapeutic value. The only published randomized clinical trial (RCT) showed no overall survival benefit after radical/systematic lymphadenectomy, although there was an impact on 6-month disease-free survival. Conversely, retrospective studies, a meta-analysis and a re-analysis of three RCTs in AOC do suggest an overall survival benefit for radical/systematic lymphadenectomy.

Summary: This review concludes with the recommendation that lymphadenectomy in EOC is a mandatory part of surgical staging and that a minimum of 10 nodes should be harvested from different retroperitoneal sites. In AOC, lymphadenectomy can be considered when intraperitoneal cytoreduction has been complete or when there are bulky nodes.

abstract: Cochrane review - Optimal primary surgical treatment for advanced epithelial ovarian cancer

Abstract

BACKGROUND:

Ovarian cancer is the sixth most common cancer among women. In addition to diagnosis and staging, primary surgery is performed to achieve optimal cytoreduction (surgical efforts aimed at removing the bulk of the tumour) as the amount of residual tumour is one of the most important prognostic factors for survival of women with epithelial ovarian cancer. An optimal outcome of cytoreductive surgery remains a subject of controversy to many practising gynae-oncologists. The Gynaecologic Oncology group (GOG) currently defines 'optimal' as having residual tumour nodules each measuring 1 cm or less in maximum diameter, with complete cytoreduction (microscopic disease) being the ideal surgical outcome. Although the size of residual tumour masses after surgery has been shown to be an important prognostic factor for advanced ovarian cancer, it is unclear whether it is the surgical procedure that is directly responsible for the superior outcome that is associated with less residual disease.

OBJECTIVES:

To evaluate the effectiveness and safety of optimal primary cytoreductive surgery for women with surgically staged advanced epithelial ovarian cancer (stages III and IV).To assess the impact of various residual tumour sizes, over a range between zero and 2 cm, on overall survival.

MAIN RESULTS:

There were no RCTs or prospective non-RCTs identified that were designed to evaluate the effectiveness of surgery when performed as a primary procedure in advanced stage ovarian cancer.We found 11 retrospective studies that included a multivariate analysis that met our inclusion criteria. Analyses showed the prognostic importance of complete cytoreduction, where the residual disease was microscopic that is no visible disease, as overall (OS) and progression-free survival (PFS) were significantly prolonged in these groups of women. PFS was not reported in all of the studies but was sufficiently documented to allow firm conclusions to be drawn.When we compared suboptimal (> 1 cm) versus optimal (< 1 cm) cytoreduction the survival estimates were attenuated but remained statistically significant in favour of the lower volume disease group There was no significant difference in OS and only a borderline difference in PFS when residual disease of > 2 cm and < 2 cm were compared (hazard ratio (HR) 1.65, 95% CI 0.82 to 3.31; and HR 1.27, 95% CI 1.00 to 1.61, P = 0.05 for OS and PFS respectively).There was a high risk of bias due to the retrospective nature of these studies where, despite statistical adjustment for important prognostic factors, selection bias was still likely to be of particular concern. Adverse events, quality of life (QoL) and cost-effectiveness were not reported by treatment arm or to a satisfactory level in any of the studies.

AUTHORS' CONCLUSIONS:

During primary surgery for advanced stage epithelial ovarian cancer all attempts should be made to achieve complete cytoreduction. When this is not achievable, the surgical goal should be optimal (< 1 cm) residual disease. Due to the high risk of bias in the current evidence, randomised controlled trials should be performed to determine whether it is the surgical intervention or patient-related and disease-related factors that are associated with the improved survival in these groups of women. The findings of this review that women with residual disease < 1 cm still do better than women with residual disease > 1 cm should prompt the surgical community to retain this category and consider re-defining it as 'near optimal' cytoreduction, reserving the term 'suboptimal' cytoreduction to cases where the residual disease is > 1 cm (optimal/near optimal/suboptimal instead of complete/optimal/suboptima

webinar notice: Best Practices for Decreasing Surgical Site Infections to be Discussed in Upcoming Patient Safety Webinar - Press Release - Digital Journal

RANZCOG College Statement on prophylactic oophorectomy in older women undergoing hysterectomy for benign disease: Is the evidence sufficient to change practice?

Conclusion:  A survey of gynaecologists revealed that few currently appear to adhere to the College Statement regarding prophylactic oophorectomy at the time of hysterectomy for benign disease. High quality evidence regarding either harm or benefit following retention of ovaries after menopause is lacking. Nevertheless, dialogue between clinicians and patients on this topic is important.

Use of SAND Balloon Catheter for Laparoscopic Management of Extremely Large Ovarian Cysts (intraperitoneal spillage)

"With proper patient selection, the SAND balloon catheter can be extremely useful in laparoscopic removal of very large adnexal masses, without intraperitoneal spillage."

Laparoscopic Intraperitoneal Port Placement for Optimally Cytoreduced Advanced Ovarian Cancer

Most women carrying cancer genes (BRCA 1/2) take action: study | Reuters

Predictive Factors in Relapsed Ovarian Cancer for Complete Tumor Resection

"Results:

Overall, 177 consecutive patients (pts) were analyzed. The median age at first diagnosis was 55 years (range, 23-83 years). The complete tumor resection rate was 44.6%. Predictive factors that correlated with an adverse surgical outcome in terms of residual tumor were ascites <500 ml (Odds ratio, OR=0.3; 95% Confidence interval, CI=0.1-0.8 p<0.05), tumor involvement of the small bowel (OR=0.22; 95% CI=0.07-0.71 p<0.05), tumor spread in the upper abdomen (OR=0.33; 95% CI=0.1-0.9 p<0.05) and platinum resistance (OR=0.1, 95% CI=0.06-0.5 p<0.01).

Serous tumor histology (OR=5.8) appeared to have a protective effect. Age and initial FIGO stage were of no predictive significance.

Conclusion:

Platinum-sensitive patients without ascites, no intestinal tumor involvement, tumor restricted to middle and lower abdomen, and of serous papillary histology have significantly higher complete tumor resection rates. Prospective studies are warranted to evaluate the predictive value of these factors."

abstract: Mechanical bowel preparation does not influence outcomes following colonic cancer resection

CONCLUSION:

Neither postoperative complications nor long-term survival are improved by MBP before colonic cancer surgery.

abstract: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: Multi-institutional phase-II trial

Conclusions.

In selected patients with advanced stage EOC, upfront CRS and HIPEC provided promising results in terms of outcome. Morbidity was comparable to aggressive cytoreduction without HIPEC. Postoperative recovery delayed the initiation of adjuvant systemic chemotherapy but not sufficiently to impact negatively on survival. These data warrant further evaluation in a randomized clinical trial.

Highlights

► Maximal surgical effort and intraperitoneal chemotherapy have been proposed as upfront treatment in epithelial ovarian cancer.
► Primary cytoreduction and hyperthermic intraperitoneal chemotherapy was performed in advanced epithelial ovarian cancer patients.
► Promising survival rates and acceptable morbidity were reported.

May 2011 - short excerpts: What's new in ACS surgery (sundry topics)