C18
Conditions
Interventions
Group 1: Laparoscopic colectomy within 90 days of diagnosis.
The treatment strategies in the target trial would be either laparoscopic (Arm 1) or open surgery (Arm 2). Our emulated trial included pat
instead, randomness was emulated by controlling for baseline confounders using inverse-probability weighting and cloning.
Group 2: Open colectomy within 90 days of diagnosis.
See also Arm 1 above.
Sponsors
Abt. Versorgungsepidemiologie und Community Health, Institut für Community Medicine, Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Target trial: Patients with solitary, primary stages I – III colon cancer aged = 18 years at diagnosis, with performance score (Eastern Cooperative Oncology Group, ECOG = 2 or Karnofsky score= 50%), and Charlson comorbidity index (CCI = 2). Emulated trial: Patients with solitary, primary stages I – III colon cancer aged = 18 years at diagnosis, with performance score ECOG = 2 or Karnofsky score = 50%, and laparoscopic or open colectomy within 3 months (90 days) after diagnosis. CCI was not documented by Mecklenburg-Western Pomerania Cancer (MV) Registry center.
Exclusion criteria
Exclusion criteria: Target trial: Body mass index (BMI) > 35 Kg/m², advanced local disease (T4), adenocarcinomas of the transverse colon and rectum (including that of appendix, hepatic flexure, splenic flexure, overlapping sites and unspecified cancer of the colon), multiple primary colon tumors, prior history of cancer in the past 5 years. However, patients with non-melanoma skin cancer (NMSC) as well as in situ tumors (ICD-10 codes D00-D09) and benign tumors (ICD-10 codes D10-D36) were not excluded. The following patients were also excluded: patients who underwent emergency colectomy, patients with gastrointestinal stromal tumor (GIST), neuroendocrine cancers, sarcoma cases, or patients with previous abdominal surgery. Additional excluded cases include robotic colectomies (OPS=5-987). Emulated trial: Advanced local disease (T4), patients diagnosed with subtypes of colon cancer located on the appendix (C18.1), hepatic flexure (C18.3), transverse colon (C18.4), splenic flexure (C18.5), or overlapping sites of the colon (C18.8), and all unspecified sites (C18.9) – as well as cancer of the rectosigmoid junction (C19) were excluded. Patients with prior history of cancer in the past 5 years (except NMSC, in situ tumors (ICD-10 codes D00-D09) and benign tumors (ICD-10 codes D10-D36)) were excluded. In addition, patients with an additional GIST diagnosis, neuroendocrine cancers, sarcoma cases, patients with previous abdominal surgery for malignant indications as well as patients treated with emergency or robotic colectomy (OPS=5-987) were also excluded. Since data on BMI, previous surgery for non-malignant indications and CCI were not available in in the Cancer Registry Center, we did not use these covariates as exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint WHAT: 5-year overall survival (OS), defined as time in months from study entry (time zero = fulfillment of eligibility criteria) until death from any cause. WHEN: 5 years after study entry Follow-up period: From diagnosis until death, last follow-up date, or administrative censoring date (31 December 2023), whichever occurred first. HOW: Vital status was ascertained and documented by the Clinical Cancer Registry of Mecklenburg-Western Pomerania Survival times of patients without a date of death or with date of death after 31 December 2023 (end of follow-up) were treated as right-censored. Patients for whom no information of death has been received are assumed to be "alive" until that point of time, which is a common practice in researches using data from the German cancer registry. This is a retrospective cohort study based on anonymized registry data (2008–2018); there was no direct patient contact, no questionnaires, and no additional clinical measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study also reports 1-year and 3-year overall survival estimates. | — |
Countries
Germany
Contacts
Public ContactSemaw Abera
Abt. Versorgungsepidemiologie und Community Health, Institut für Community Medicine, Universitätsmedizin Greifswald
Outcome results
None listed