SexSeDiGCSNCT07017712
Sex Differences in Gastrointestinal Cancer Surgery
An observational study of Sex and Gastrointestinal Cancers, run by Medizinische Hochschule Brandenburg Theodor Fontane.
Trial summary
This study aims to investigate whether there are differences in surgical outcomes between male and female patients with gastrointestinal cancers (esophagus, colon, rectum, stomach, or pancreas). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sex, Gastrointestinal Cancers, Surgical Resection
- What is being tested?
- Complex esophageal surgery for carcinoma, Rectum resection for carcinoma and Colon resection for carcinoma
- Type of treatment
- Surgery or procedure
- How many people
- 870,754 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population based study. Principally all patients that underwent any of the described procedures in an German hospital are included in the dataset.
Who may be able to join
- at least 18 years old at the time of the operation
- Rectum resection for carcinoma (ICD-10: C19, C20, C218, D01.1, D01.2) and appropriate resection procedure (5-484, 5-485)
- Colon resection for carcinoma (ICD-10: C18, D01.0) and appropriate resection procedure (5-455, 5-456, 5-458)
- Complex esophageal surgery for carcinoma (ICD-10: C15, C16.0) and appropriate resection procedure (5-423, 5-424, 5-425, 5-426, 5-427.0, 5-427.1, 5-438.0, 5-438.1, 5-438.x)
- Pancreatic resection for carcinoma (ICD-10: C25, C24.1) and appropriate resection procedure (5-524, 5-525.0, 5-525.1, 5-525.2, 5-525.x, 5-525.y, 5-528)
- Gastric resection for carcinoma (ICD-10: C16) and appropriate resection procedure (5-436, 5-437, 5-438)
Who cannot join
- missing data for age and/or sex
- implausible combination of diagnosis and resection procedure (eg. a patient with a gastrectomy but without appropriate ICD-10 diagnosis)
About this study
This study aims to investigate whether there are differences in surgical outcomes between male and female patients with gastrointestinal cancers (esophagus, colon, rectum, stomach, or pancreas). Previous research suggests that women may have worse outcomes after high-risk surgeries, such as heart or vascular procedures, but it is unclear if this applies to gastrointestinal cancer surgery. The study will analyze population based data from Germany to compare how often male and female patients died or died after the occurence of a surgical complication (failure to rescue) after surgery. The goal is to determine if biological sex influences surgical risks and recovery, which could help improve personalized care for cancer patients.
Read the detailed description
DATA SOURCE
As database the German diagnosis-related group statistic (DRG statistic) will be queried. The dataset is provided by the German Federal Statistical Office. It includes standardized demographic information (age, sex), diagnostic codes (ICD-10-GM), procedural codes (OPS), and outcomes (mortality, length of stay, complications). Patients will be included if they underwent resection for one of the five specified cancers; exclusions applied for age <18 years, missing sex/age data, or non-matching diagnosis-procedure pairs.
OUTCOMES
Primary Endpoints:
Mortality: Death during the hospital stay. Failure-to-Rescue (FTR): Death among patients who developed postoperative complications (defined via appropriate ICD-10-GM/OPS codes)
Secondary Endpoints: 30-day mortality, complication rates, intensive care unit (ICU) admission, reoperation, and prolonged hospitalization (>75th percentile for procedure-specific stay). Failure to rescue rates of patients with extended medical treatment (eg. after reoperation, ICU admission, possibly in combination with a complication).
Adjustment Variables: Age, Elixhauser comorbidities (categorized using Quan's algorithm), admission type (elective/emergent), annual hospital procedure volume (to account for surgical expertise and routine), and year of surgery (to account for temporal trends).
Descriptive Analysis:
Data Validation: Checks will be performed to identify implausible values (e.g., age >120 years) or inconsistencies (e.g., mortality coded without complication for FTR analysis). Comorbidity Coding: Elixhauser comorbidities will be determined. Hospital Volume Metrics: Annual procedure volumes will be calculated to control for institutional expertise.
Statistical Analysis Plan As primary analysis, multivariable logistic regression models will be calculated that assessed sex differences in mortality/FTR, adjusting for covariates (age, individual Elixhauser comorbidities, hospital volume, and admission type, year of surgery). Adjusted odds ratios (aORs) and adjusted risk differences (aRD) with 95% confidence intervals (CIs) will be reported.
Subgroup / Sensitivity Analyses:
To ensure robustness of results multiple sensitivity analyses will be performed. These include subgroup analysis where tha analysis will be perfomed by startified groups:
- by admission type (elective vs. emergent),
- by comorbidity burden (≤3 vs. >4 Elixhauser conditions), and
- by hospital volume (above/below median).
REPORTING
Descriptive/Univariable analysis:
This study will report descriptively baseline patient characteristics and compare the charachteristics between male and female patients. Tests will be selected according to variable type (categorical vs. continuous) and type of distribution (normal vs non-normal distributed).
Observed outcome rates will be reported and compared between male and female patients. Observed risk differences and risk ratios will be calculated.
Multivariable analysis:
Results of the multivariable logistic regressions will be reported as adjusted risk differences and/or adjusted risk ratios. Appropriate figures will be produced to communicate the results. Sensitivity analyses stratified by admission type, comorbidity burden, and hospital volume will reinforce the robustness of these results.
- Conditions
- Sex, Gastrointestinal Cancers, Surgical Resection, Sex Differences
- Being tested
- Complex esophageal surgery for carcinoma, Rectum resection for carcinoma, Colon resection for carcinoma, Pancreatic resection for carcinoma, Gastric resection for carcinoma
- Keywords
- Surgical Outcomes, Sex Differences, Surgical Otcomes Research
- Medical subject headings
- Coitus, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex esophageal surgery for carcinomaProcedure or surgery
Appropriate combination of ICD-10 code (C15, C16.0) and medical procedure code (5-423, 5-424, 5-425, 5-426, 5-427.0, 5-427.1, 5-438.0, 5-438.1, 5-438.x)
Rectum resection for carcinomaProcedure or surgery
Appropriate combination of ICD-10 code (C19, C20, C218, D011, D012) and medical procedure code (5-484, 5-485)
Colon resection for carcinomaProcedure or surgery
Appropriate combination of ICD-10 code (C18, D01.0) and medical procedure code (5-455, 5-456, 5-458)
Pancreatic resection for carcinomaProcedure or surgery
Appropriate combination of ICD-10 code (C25, C24.1) and medical procedure code (5-524, 5-525.0, 5-525.1, 5-525.2, 5-525.x, 5-525.y, 5-528)
Gastric resection for carcinomaProcedure or surgery
Appropriate combination of ICD-10 code (C16) and medical procedure code (5-436, 5-437, 5-438)
| Study group | Role | What they receive |
|---|---|---|
| Male patients | Not described Receives: Procedure: Complex esophageal surgery for carcinoma; Procedure: Rectum resection for carcinoma; Procedure: Colon resection for carcinoma; Procedure: Pancreatic resection for carcinoma; Procedure: Gastric resection for carcinoma | |
| Female patients | Not described Receives: Procedure: Complex esophageal surgery for carcinoma; Procedure: Rectum resection for carcinoma; Procedure: Colon resection for carcinoma; Procedure: Pancreatic resection for carcinoma; Procedure: Gastric resection for carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Proportion of patients that died after surgical intervention
Measured: Up to 90 days postoperatively
Failure to rescue
Proportion of patients that died after the occurence of a postoperative complication
Measured: Up to 90 days postoperatively
Secondary outcomes (5)
Complication rate
Folloing individual comorbidities are considered:
Acute myocardial infarction Acute pulmonary embolism Pulmonary insufficiency Sepsis Shock during or resulting from a procedure Shock due to anaesthesia Toxic shock Septic shock Anaphylactic shock Renal failure Haemorrhage Accidental puncture and laceration during a procedure Disruption of operation wound Infection Foreign body accidentally left in body cavity or operation wound following a procedure Acute reaction to foreign substance accidentally left during a procedure Vascular complications following a procedure Other complications of procedures Pancreatoduodenal fistula Peritonitis Anastomotic insufficiency Postoperative bowel occlusion Blood transfusion Other specified complications of surgical and medical care Complication of surgical and medical care, unspecified
Measured: Up to 90 days postoperatively
Reoperation rate
Reoperation during the same hospital stay of the index operation. Identified using the following medical procedure code: 5-983.
Measured: Up to 90 days postoperatively
Intensive Care Unit admission
Postoperative admission to the Intensive Care Unit
Measured: Up to 90 days postoperatively
Prolonged Lenght of Stay
Length of stay above the 75. percentile of all patients with the same diagnosis / procedure combination
Measured: Up to 90 days postoperatively
Failure to rescue
Proportion of patients that died after the occurence of any of the other secondary outcome measures
Measured: Up to 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 870,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Hunger, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017712
- Sponsor's protocol ID
- SeDiGCS
- Acronym
- SeDiGCS
- Status last verified
- May 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dissemination of Diagnosis-Related Group (DRG) statistics is not a viable option due to the centralised management of such data by the Federal Statistical Office of Germany, which restricts accessibility and analysis to remote mechanisms.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Gastrointestinal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07017712
- Acronym / sponsor ID
- SeDiGCS / SeDiGCS
- Conditions
- Sex, Gastrointestinal Cancers, Surgical Resection, Sex Differences
- Keywords
- Surgical Outcomes, Sex Differences, Surgical Otcomes Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 870,754 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether there are differences in surgical outcomes between male and female patients with gastrointestinal cancers (esophagus, colon, rectum, stomach, or pancreas). Previous research suggests that women may have worse outcomes after high-risk surgeries, such as heart or vascular procedures, but it is unclear if this applies to gastrointestinal cancer surgery. The study will analyze population based data from Germany to compare how often male and female patients died or died after the occurence of a surgical complication (failure to rescue) after surgery. The goal is to determine if biological sex influences surgical risks and recovery, which could help improve personalized care for cancer patients.
Detailed description
DATA SOURCE
As database the German diagnosis-related group statistic (DRG statistic) will be queried. The dataset is provided by the German Federal Statistical Office. It includes standardized demographic information (age, sex), diagnostic codes (ICD-10-GM), procedural codes (OPS), and outcomes (mortality, length of stay, complications). Patients will be included if they underwent resection for one of the five specified cancers; exclusions applied for age <18 years, missing sex/age data, or non-matching diagnosis-procedure pairs.
OUTCOMES
Primary Endpoints:
Mortality: Death during the hospital stay. Failure-to-Rescue (FTR): Death among patients who developed postoperative complications (defined via appropriate ICD-10-GM/OPS codes)
Secondary Endpoints: 30-day mortality, complication rates, intensive care unit (ICU) admission, reoperation, and prolonged hospitalization (>75th percentile for procedure-specific stay). Failure to rescue rates of patients with extended medical treatment (eg. after reoperation, ICU admission, possibly in combination with a complication).
Adjustment Variables: Age, Elixhauser comorbidities (categorized using Quan's algorithm), admission type (elective/emergent), annual hospital procedure volume (to account for surgical expertise and routine), and year of surgery (to account for temporal trends).
Descriptive Analysis:
Data Validation: Checks will be performed to identify implausible values (e.g., age >120 years) or inconsistencies (e.g., mortality coded without complication for FTR analysis). Comorbidity Coding: Elixhauser comorbidities will be determined. Hospital Volume Metrics: Annual procedure volumes will be calculated to control for institutional expertise.
Statistical Analysis Plan As primary analysis, multivariable logistic regression models will be calculated that assessed sex differences in mortality/FTR, adjusting for covariates (age, individual Elixhauser comorbidities, hospital volume, and admission type, year of surgery). Adjusted odds ratios (aORs) and adjusted risk differences (aRD) with 95% confidence intervals (CIs) will be reported.
Subgroup / Sensitivity Analyses:
To ensure robustness of results multiple sensitivity analyses will be performed. These include subgroup analysis where tha analysis will be perfomed by startified groups:
- by admission type (elective vs. emergent),
- by comorbidity burden (≤3 vs. >4 Elixhauser conditions), and
- by hospital volume (above/below median).
REPORTING
Descriptive/Univariable analysis:
This study will report descriptively baseline patient characteristics and compare the charachteristics between male and female patients. Tests will be selected according to variable type (categorical vs. continuous) and type of distribution (normal vs non-normal distributed).
Observed outcome rates will be reported and compared between male and female patients. Observed risk differences and risk ratios will be calculated.
Multivariable analysis:
Results of the multivariable logistic regressions will be reported as adjusted risk differences and/or adjusted risk ratios. Appropriate figures will be produced to communicate the results. Sensitivity analyses stratified by admission type, comorbidity burden, and hospital volume will reinforce the robustness of these results.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male patients | – | Procedure: Complex esophageal surgery for carcinoma, Procedure: Rectum resection for carcinoma, Procedure: Colon resection for carcinoma, Procedure: Pancreatic resection for carcinoma, Procedure: Gastric resection for carcinoma |
| Female patients | – | Procedure: Complex esophageal surgery for carcinoma, Procedure: Rectum resection for carcinoma, Procedure: Colon resection for carcinoma, Procedure: Pancreatic resection for carcinoma, Procedure: Gastric resection for carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population based study. Principally all patients that underwent any of the described procedures in an German hospital are included in the dataset.
Key inclusion criteria (6 listed)
- at least 18 years old at the time of the operation
- Rectum resection for carcinoma (ICD-10: C19, C20, C218, D01.1, D01.2) and appropriate resection procedure (5-484, 5-485)
- Colon resection for carcinoma (ICD-10: C18, D01.0) and appropriate resection procedure (5-455, 5-456, 5-458)
- Complex esophageal surgery for carcinoma (ICD-10: C15, C16.0) and appropriate resection procedure (5-423, 5-424, 5-425, 5-426, 5-427.0, 5-427.1, 5-438.0, 5-438.1, 5-438.x)
- Pancreatic resection for carcinoma (ICD-10: C25, C24.1) and appropriate resection procedure (5-524, 5-525.0, 5-525.1, 5-525.2, 5-525.x, 5-525.y, 5-528)
Key exclusion criteria (2 listed)
- missing data for age and/or sex
- implausible combination of diagnosis and resection procedure (eg. a patient with a gastrectomy but without appropriate ICD-10 diagnosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex esophageal surgery for carcinomaAppropriate combination of ICD-10 code (C15, C16.0) and medical procedure code (5-423, 5-424, 5-425, 5-426, 5-427.0, 5-427.1, 5-438.0, 5-438.1, 5-438.x) | Procedure or surgery | Female patients, Male patients |
| Rectum resection for carcinomaAppropriate combination of ICD-10 code (C19, C20, C218, D011, D012) and medical procedure code (5-484, 5-485) | Procedure or surgery | Female patients, Male patients |
| Colon resection for carcinomaAppropriate combination of ICD-10 code (C18, D01.0) and medical procedure code (5-455, 5-456, 5-458) | Procedure or surgery | Female patients, Male patients |
| Pancreatic resection for carcinomaAppropriate combination of ICD-10 code (C25, C24.1) and medical procedure code (5-524, 5-525.0, 5-525.1, 5-525.2, 5-525.x, 5-525.y, 5-528) | Procedure or surgery | Female patients, Male patients |
| Gastric resection for carcinomaAppropriate combination of ICD-10 code (C16) and medical procedure code (5-436, 5-437, 5-438) | Procedure or surgery | Female patients, Male patients |
Primary outcome
Mortality rate
Time frame: Up to 90 days postoperatively
Proportion of patients that died after surgical intervention
Failure to rescue
Time frame: Up to 90 days postoperatively
Proportion of patients that died after the occurence of a postoperative complication
5 secondary outcomes
Complication rate
Time frame: Up to 90 days postoperatively
Reoperation rate
Time frame: Up to 90 days postoperatively
Intensive Care Unit admission
Time frame: Up to 90 days postoperatively
Prolonged Lenght of Stay
Time frame: Up to 90 days postoperatively
Failure to rescue
Time frame: Up to 90 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. The dissemination of Diagnosis-Related Group (DRG) statistics is not a viable option due to the centralised management of such data by the Federal Statistical Office of Germany, which restricts accessibility and analysis to remote mechanisms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sex and Gastrointestinal Cancers, run by Medizinische Hochschule Brandenburg Theodor Fontane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: Up to 90 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.