Interventional procedure overview of maximal effort cytoreductive surgery for advanced ovarian cancer

Unspecified complications

At least 1 complication was reported in 30% of patients in the cohort study of 247 patients. A grade 3 or higher complication (using Clavien–Dindo classification) was reported in 14% of patients. Overall complication rates were 20% in the low SCS group, 26% in the intermediate SCS group and 52% in the high SCS group (p<0.001). The rates of grade 3 or higher complications were 9% in the low SCS group, 13% in the intermediate SCS group and 25% in the high SCS group (p value not stated; Sundar 2022).

The overall rate of major (grade 3 to 5) complications was 15% (148/978) in the cohort of 978 patients and was similar across time periods. It was 13% (41/315) in those who were treated between 2001 and 2005, 16% (51/320) in those who were treated between 2006 and 2009 and 16% (56/343) for those who were treated between 2010 and 2013 (p=0.440; Tseng 2018).

The overall rate of major surgical complications was 22% (123/549) in a cohort study of 549 patients who had primary, interval or closure debulking surgery with either complete cytoreduction or cytoreduction to minimal residual disease for Stage 3c to 4 epithelial ovarian, fallopian, or primary peritoneal cancer. Of the 123 patients, 75 (61%) had a SCS of 8 or above compared with 45% (249/549) for the whole cohort (p<0.001). A high SCS was not identified as a factor associated with major surgical complications in multiple logistic regression analysis (OR 0.93, 95% CI 0.42 to 2.07, p=0.863; Angeles 2022).

Patients who had multiple bowel resections had a RR of 7.73 (95% CI 3.92 to

15.26), patients with a high SCS had an RR of 6.12 (95% CI 3.25 to 11.52), patients with diaphragmatic surgery and gastrointestinal anastomosis had an RR of 5.57 (95% CI 2.65 to 11.72), patients with any gastrointestinal resection had an RR of 4.69 (95% CI 2.66 to 8.24), patients with ultra-radical surgery had an RR of 4.65 (95% CI 2.26 to 8.79), and patients with supra-radical surgery had an RR of 4.20 (95% CI 2.35 to 7.51) of grades 3 to 5 morbidity, compared with patients who had standard surgery as defined by the NICE classification used in the study (Phillips 2019).

Mortality

Mortality was 1% (3/247) in the cohort study of 247 patients. Causes of death were disseminated intravascular coagulation and multiorgan failure, pulmonary embolism, and intra-abdominal sepsis. Of the 3 patients, 2 were in the intermediate SCS group and 1 was in the low SCS group (Sundar 2022).

Overall 30-day all-cause mortality was less than 1% (4/978) and 90-day all-cause mortality was 1% (13/975) in the cohort study of 978 patients. 90-day mortality decreased over time from 2.9% in those who were treated between 2001 and 2005, 1% in those who were treated between 2006 and 2009 and 0% for those who were treated between 2010 and 2013 (p=0.002; Tseng 2018).

Mortality caused by postoperative complications (Clavien–Dindo grade 5) was reported in 2% (10/549) of patients in the cohort study of 549 patients (Angeles 2022).

30-day mortality was less than 1% (1/384) and 90-day mortality was 1% (4/384) in the cohort study of 384 patients. The death within 30 days was caused by sepsis, multiple organ failure and cardiac arrest (Palmqvist 2022).

The weighted mean perioperative mortality was 4.6% (95% CI 4.6 to 4.7) in a systematic review of 18,579 patients (46 studies) who had primary cytoreductive surgery for ovarian cancer. The number of surgical procedures, weighted surgical complexity index, and highest procedure complexity were computable in 26 cohorts included in the review. There was no statistically significant association between the weighted mean value of these parameters and the incidence rate of mortality, although an inverse trend was observed (Di Donato 2017).

Digestive complications

Major digestive complications were reported in 9% (51/549) of patients in the cohort study of 549 patients (Angeles 2022). Return to theatre for gastric perforation, subsequent enterocutaneous fistula and tracheostomy was reported in 1 patient who had ultra-radical surgery in the cohort study of 608 patients (Phillips 2019).

Return to theatre for anastomotic leak was reported in 2 patients who had standard surgery and 2 patients who had ultra-radical surgery in the cohort study of 608 patients. Another patient in the ultra-radical surgery group was returned to theatre for anastomotic leak and sheath dehiscence (Phillips 2019). Grade 3b anastomotic leakage and suspected anastomotic leakage, treated by surgery, were reported in 1 patient each in the cohort study of 384 patients. Grade 4b anastomotic leakage, treated by surgery followed by intensive care, was reported in 1 patient in the same study (Palmqvist 2022).

Infection

Major infectious complications were reported in 9% (49/549) of patients in the cohort study of 549 patients (Angeles 2022). Return to theatre for paraspinal infection was reported in 1 patient who had ultra-radical surgery in the cohort study of 608 patients. Another patient in this group died from pancreatitis and acute respiratory distress syndrome (Phillips 2018). Intra-abdominal abscess treated by drainage was reported in 1 patient and vaginal vault abscess treated by drainage was reported in 2 patients in the cohort study of 384 patients. Intra-abdominal abscess and stoma necrosis that needed surgical intervention were reported in 1 patient each, and sepsis with multiple organ failure needing intensive care was reported in 1 patient in the same study (Palmqvist 2022).

Infection was the most common cause of death identified in the systematic review of 18,579 patients (46 studies) who had primary cytoreductive surgery for ovarian cancer (Di Donato 2017).

Respiratory complications

Major respiratory complications were reported in 5% (28/549) of patients in the cohort study of 549 patients (Angeles 2022).

Chest drain insertion with or without bronchoscopy was reported in 1 patient who had standard surgery and 4 patients who had ultra-radical surgery in the cohort study of 608 patients. One patient in the ultra-radical surgery group died from pulmonary embolus (Phillips 2019).

Pleural fluid drainage was reported in 4% (16/384) of patients in the cohort study of 384 patients. Pulmonary failure that needed intensive care treatment was reported in 0.5% (2/384) patients in the same study (Palmqvist 2022).

Abdominal wall complications

Major abdominal wall complications were reported in 4% (24/549) of patients in the cohort study of 549 patients (Angeles 2022).

Diaphragmatic hernia was described in 4 patients after debulking surgery for advanced ovarian cancer in a case series. They were diagnosed at 5, 6, 8 and 18 months after the procedure and were treated surgically (Ehmann 2021).

Wound complications

Grade 3 wound resuturing and wound seroma were reported in 1 patient each and wound infection was reported in 2 patients in the cohort study of 384 patients. Grade 4 wound haematoma that needed to be resutured was reported in 1 patient and wound dehiscence that needed to be resutured was reported in 2 patients in the same study (Palmqvist 2022).

Lymphatic complications

Major lymphatic complications were reported in 4% (19/549) of patients in the cohort study of 549 patients (Angeles 2022).

Haemorrhagic complications

Major haemorrhagic complications were reported in 3% (18/549) of patients in the cohort study of 549 patients (Angeles 2022). Return to theatre for grade 3 haematoma or bleeding was reported in 2 patients who had standard surgery and 2 patients who had ultra-radical surgery in the cohort study of 608 patients. Intraoperative splenectomy for iatrogenic bleeding was reported in 1 patient who had ultra-radical surgery and another had to return to theatre for splenectomy, liver failure, renal failure and pancreatitis (Phillips 2019). Intra-abdominal bleeding that needed surgical intervention was reported in 0.5% (2/384) of patients in the cohort study of 384 patients. Intra-abdominal abscess and bleeding, and bleeding diaphragm that needed surgical intervention were reported in 1 patient each in the same study (Palmqvist 2022).

Urinary or renal complications

Major urinary or renal complications were reported in 2% (13/549) of patients in the cohort study of 549 patients (Angeles 2022). Grade 4 renal failure and urinary tract fistula were reported in 1 patient each who had ultra-radical surgery in the cohort study of 608 patients (Phillips 2019). Hydronephrosis, treated by nephrostomy, was reported in 0.5% (2/384) of patients in the cohort study of 384 patients. Urinary tract injury, treated by surgery, was reported in 1 patient in the same study (Palmqvist 2022).

Cardiac complications

A major cardiac event was reported in 2% (10/549) of patients in the cohort study of 549 patients (Angeles 2022). Cardiac pacing after sinus arrest was reported in 1 patient who had ultra-radical surgery in the cohort study of 608 patients (Phillips 2019).

Neurological complications

A major neurological event was reported in less than 1% (2/549) of patients in the cohort study of 549 patients (Angeles 2022).

Anecdotal and theoretical adverse events

In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

For this procedure, professional experts listed the following additional anecdotal or theoretical adverse events: pancreatic leaks, pneumonia, pneumothorax, reduced immune response (secondary to splenectomy), weight loss and reduced absorption (after partial gastrectomy), chylous ascites, bile duct injury, devascularisation of the foregut, liver ischaemia, short gut syndrome.