SUCCOR morbidity: complications in minimally invasive versus open radical hysterectomy in early cervical cancer

Accrual and Data Source

We collected data from the SUCCOR database. This database consisted of 1272 patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009) who underwent a radical hysterectomy in Europe from January 2013 to December 2014. Researchers from 126 institutions in 29 European countries registered and contributed to the project.

Inclusion and Exclusion Criteria

As detailed in the study by Boria et al,12 patients were eligible if they had undergone radical hysterectomy for stage IB1 cervical cancer (FIGO, 2009) in a European institution. A total of 1272 patients were evaluated; however, 116 patients did not meet the inclusion criteria of age ≥18 years and histologic type (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Pelvic MRI confirming a tumor diameter ≤4 cm with no parametrial invasion and a pre-operative CT scan, MRI, or positron emission tomography (PET) CT demonstrating no extra-cervical metastatic disease were mandatory. The operative report had to describe type B–C radical hysterectomy with bilateral pelvic lymphadenectomy by either minimally invasive surgery (laparoscopic or robotic) or open surgery, including at least 10 pelvic nodes. Women who underwent only sentinel lymph node mapping were included in the study, but data regarding tumor size, margins, and nodal status were required. Exclusion criteria were as follows: (1) final tumor stage IA; (2) history of any invasive tumor other than cervical cancer; (3) previous chemotherapy or radiation; and (4) conversion from minimally invasive surgery to open laparotomy (as it was stated in the SUCCOR database).

Statistical Analysis

Baseline demographics were summarized in terms of frequency. Outcomes of interest were any grade >3 adverse events, intra-operative adverse events, post-operative adverse events, length of hospital stay, length of operation, and blood loss. An intra-operative adverse event was defined as any unfavorable medical complication that occurred during the surgery in an enrolled patient, irrespective of its causal relationship with the study treatment. A post-operative adverse event is a complication that occurs within 30 days after surgery.

Intra-operative complications were classified according to the CLASSIC classification.13 Grade 1 is any deviation from the ideal intra-operative course without the need for any additional treatment or intervention. Grade 2 is any deviation from the ideal intra-operative course with the need for additional treatment or intervention, not life-threatening, and not leading to permanent disability. Grade 3 is any deviation from the ideal intra-operative course with the need for additional treatment or intervention, life-threatening, and/or leading to permanent disability. Grade 4 is any deviation from the ideal intra-operative course with death of the patient.

Post-operative complications were classified according to the Clavien–Dindo scale. Grade 1 is any deviation from the normal post-operative course without the need for pharmacological treatment other than the allowed therapeutic regimens or surgical, endoscopic, and radiological interventions. Grade 2 is requiring pharmacological treatment with drugs beyond those allowed for grade 1 complications, grade 3 is requiring surgical, endoscopic, or radiological intervention, grade 4 is life-threatening complication requiring critical care management, and grade 5 is death of the patient.

Continuous variables were summarized as mean (SD) and range and were compared between surgical techniques using a t-test. Categorical outcomes were summarized as frequency and were compared between surgical techniques using a χ2 test. Adverse events were summarized in two ways: overall and by specific adverse events of interest. For all analyses, adverse events were not treated as mutually exclusive and patients were included in all appropriate summaries. In each case the numerator was the number of patients who had experienced the adverse event being described and the denominator was the total number of patients (per arm). P values <0.05 were considered statistically significant. The analyses were performed with SPSS v.26.0.

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