Colorectal Resections in Patients With Retroperitoneal Sarcoma (COLOSARC-Q)

December 4, 2025 updated by: Jens Jakob, Heidelberg University

Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life

COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of life.

In multivisceral resections involving the colon and rectum, the primary aim is to achieve complete resection and preserve organ function. However, multivisceral resections have a high risk of perioperative morbidity including anastomotic leakage. The proposed project aims to determine the number of primary anastomoses, their insufficiency rates, and the fraction of patients with primary and secondary stomas. In addition, the patients' quality of life after multivisceral sarcoma resection is to be recorded using standardized surveys.

The analysis has the potential to facilitate intraoperative decision-making for colorectal resections in the context of multivisceral resections.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The primary goal of retroperitoneal sarcoma surgery is to achieve complete resection. The resection of retroperitoneal sarcomas (RPS) usually involves the removal of parts of the colon. While there is good data on surgical principles and postoperative complications of multivisceral resections in RPS as a whole (1, 2), there is little evidence on the frequency of temporary or permanent stomas and complications associated with intestinal surgery (e.g., number of anastomotic leackages in relation to the number of intestinal anastomoses performed) and their impact on the quality of life of those affected.

The COLOSARC-Q study is a multicenter, non-interventional study with the aim of documenting

  • colorectal resection and reconstruction techniques in connection with multivisceral resections in retroperitoneal sarcomas (RPS),
  • complications associated with intestinal surgery in multivisceral resections, and
  • the resulting effects on the quality of life of sarcoma patients. The project plans to include 120 patients with retroperitoneal sarcomas who have undergone colon resection as part of a multivisceral resection at a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria. For these patients, patient-, tumor-, and treatment-specific parameters (all patients), standardized questionnaires on health-related quality of life (EORTC QLQ - C30 (version 3.0)) and bowel function (EORTC QLQ - CR29) (expected response rate ≥ 50%) and semi-structured interviews with the aim of recording specific problems that may not be covered in the questionnaires (e.g., regarding stoma placement, nutritional status, treatment sequence, or home care; n = 10-15).

COLOSARC-Q has the potential to improve preoperative participatory decision-making and intraoperative strategy in colorectal resections as part of multivisceral resections in order to reduce complication rates and develop surgical strategies tailored to specific patient needs.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany
      • Dresden, Germany
        • Recruiting
        • University Medical Center Dresden
        • Contact:
          • Johanna Kirchberg
          • Phone Number: 0049(0)351 458-4500
          • Email: sarkome@ukdd.de
      • Erlangen, Germany
      • Halle, Germany
        • Recruiting
        • University Medical Center Halle
        • Contact:
          • Ulrich Ronellenfitsch, Prof.
          • Phone Number: +49 345 557 2143
      • Hamburg, Germany
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
          • Anna Duprée, Dr.
          • Phone Number: +49 (0) 40 - 7410 - 55692
      • Hanover, Germany
        • Recruiting
        • Medical University of Hannover
        • Contact:
          • Ulrich Zwirner, Dr.
          • Phone Number: +49 511532 2032
      • Heidelberg, Germany
        • Recruiting
        • Heidelberg University Hospital
        • Contact:
          • Cosima Engerer, Dr.
          • Phone Number: +49 6221 483713
      • Magdeburg, Germany
        • Recruiting
        • University Hospital Magdeburg
        • Contact:
          • Roland S Croner, Prof.
          • Phone Number: +49 391 67-15500
      • München, Germany
        • Recruiting
        • LMU Hospital
        • Contact:
          • Markus Albertsmeier, Dr.
          • Phone Number: +49 (0)89 4400 74798
      • Tübingen, Germany
        • Recruiting
        • University Medical Center Tübingen
        • Contact:
      • Ulm, Germany
        • Recruiting
        • University Medical Center Ulm
        • Contact:
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Sarcoma Center of University Medical Center Mannheim
        • Contact:
  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • Sarcoma Center University of Basel
        • Contact:
          • Alexander Willhelm, Dr.
          • Phone Number: +41 61 777 73 17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with primary, retroperitoneal sarcomas who underwent surgery with colorectal resection at DKG-certified sarcoma centers or hospitals in Germany and Switzerland that meet certification-equivalent criteria.

Description

Inclusion Criteria:

  • Histological confirmation with evidence of a retroperitoneal sarcoma
  • Tumor resection with colorectal resection
  • Surgery in a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria
  • Age 18 years or older
  • Written consent

Exclusion Criteria:

  • Absence of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with primary, retroperitoneal sarcomas who underwent surgery with colorectal resection
Patients with primary retroperitoneal sarcomas who underwent surgery with colorectal resection at DKG-certified sarcoma centers or hospitals in Germany and Switzerland that meet certification-equivalent criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas
Time Frame: immediately after the surgery
Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis
immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications associated with resections and reconstructions of the bowel
Time Frame: up to 90 days after surgery
Evaluation of postoperative complications associated with resections and reconstructions of the bowel during and after multivisceral resections of retroperitoneal sarcomas (Comprehensive Complication Index (CCI), up to 90 days postoperatively)
up to 90 days after surgery
Assessment of quality of life after colorectal resections in the context of RPS resections
Time Frame: through study completion, an average of 1 year
Assessment of quality of life after using the EORTC QLQ - C30 (Version 3.0) questionnaires)
through study completion, an average of 1 year
Assessment of changes in bowel function after resection of retroperitoneal sarcomas
Time Frame: through study completion, an average of 1 year
Assessment of the bowel function using the EORTC QLQ - CR29 questionnaire
through study completion, an average of 1 year
Identification of problems and needs of RPS patients
Time Frame: through study completion, an average of 1 year
Identification of problems and needs of RPS patients who have undergone resection and reconstruction of the colon, e.g. with regard to education, home care, bowel function, stoma care, rehabilitation measures and therapy intensity and sequence
through study completion, an average of 1 year
Determination of patient-, tumor- and treatment-related factors influencing the above-mentioned primary and secondary study objectives
Time Frame: through study completion, an average of 1 year

Determination of the influence of the following patient-, tumor- and treatment-related factors on the above-mentioned primary and secondary study objectives:

  • Gender
  • age
  • Body mass index (BMI)
  • Malnutrition (serum albumin preoperatively)
  • Concomitant diseases (e.g. diabetes mellitus, coronary heart disease)
  • Previous abdominal surgery
  • Size, localization (left/right), grading and histological subtype of the RPS
  • Neoadjuvant therapies (radiotherapy and/or chemotherapy)
  • Operation time
  • Intraoperative blood loss
  • Extent of the surgical procedure
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Jens Jakob, Prof., Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-562
  • DRKS00034135 (Other Identifier: German Register of Clinical Studies (DRKS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma, Soft Tissue

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe