Sex Differences in Gastrointestinal Cancer Surgery

NCT07017712 | Completed

• 1 other identifier: SeDiGCS
• Study Type: observational
• Target: 870,754
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Sex; Gastrointestinal Cancers; Surgical Resection; Sex Differences

Keywords

Surgical Outcomes; Sex Differences; Surgical Otcomes Research

Outcome Measures

Primary Outcomes (2)

• Mortality rate

  Proportion of patients that died after surgical intervention

  Up to 90 days postoperatively

• Failure to rescue

  Proportion of patients that died after the occurence of a postoperative complication

  Up to 90 days postoperatively

Secondary Outcomes (5)

• Complication rate

  Up to 90 days postoperatively

• Reoperation rate

  Up to 90 days postoperatively

• Intensive Care Unit admission

  Up to 90 days postoperatively

• Prolonged Lenght of Stay

  Up to 90 days postoperatively

• Failure to rescue

  Up to 90 days postoperatively

Study Arms (2)

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

Interventions

Complex esophageal surgery for carcinoma PROCEDURE

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)

Female patients; Male patients

Rectum resection for carcinoma PROCEDURE

Appropriate combination of ICD-10 code (C19, C20, C218, D011, D012) and medical procedure code (5-484, 5-485)

Female patients; Male patients

Colon resection for carcinoma PROCEDURE

Appropriate combination of ICD-10 code (C18, D01.0) and medical procedure code (5-455, 5-456, 5-458)

Female patients; Male patients

Pancreatic resection for carcinoma PROCEDURE

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)

Female patients; Male patients

Gastric resection for carcinoma PROCEDURE

Appropriate combination of ICD-10 code (C16) and medical procedure code (5-436, 5-437, 5-438)

Female patients; Male patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population based study. Principally all patients that underwent any of the described procedures in an German hospital are included in the dataset.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead

MeSH Terms

Conditions

Coitus; Gastrointestinal Neoplasms

Interventions

Proctectomy; Gastrectomy

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior research assistant

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: January 1, 2010
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share