Colorectal Resections in Patients With Retroperitoneal Sarcoma

NCT06943612 | Recruiting

• 2 other identifiers: 2024-562DRKS00034135
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 13

Brief Summary

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.

Conditions

Sarcoma, Soft Tissue; Retroperitoneal Sarcoma

Keywords

Soft tissue sarcoma; Retroperitoneal Sarcoma; Sarcoma Surgery; Stoma; Colorectal resection

Outcome Measures

Primary Outcomes (1)

• Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas

  Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis

  immediately after the surgery

Secondary Outcomes (5)

• Postoperative complications associated with resections and reconstructions of the bowel

  up to 90 days after surgery

• Assessment of quality of life after colorectal resections in the context of RPS resections

  through study completion, an average of 1 year

• Assessment of changes in bowel function after resection of retroperitoneal sarcomas

  through study completion, an average of 1 year

• Identification of problems and needs of RPS patients

  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

  through study completion, an average of 1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Absence of consent

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (13)

Sarcoma Center of University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Helios Hospital Berlin-Buch

Berlin, Germany

RECRUITING

University Medical Center Dresden

Dresden, Germany

RECRUITING

University Medical Center Erlangen

Erlangen, Germany

RECRUITING

University Medical Center Halle

Halle, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Medical University of Hannover

Hanover, Germany

RECRUITING

Heidelberg University Hospital

Heidelberg, Germany

RECRUITING

University Hospital Magdeburg

Magdeburg, Germany

RECRUITING

LMU Hospital

München, Germany

RECRUITING

University Medical Center Tübingen

Tübingen, Germany

RECRUITING

University Medical Center Ulm

Ulm, Germany

RECRUITING

Sarcoma Center University of Basel

Basel, Switzerland

RECRUITING

Related Publications (5)

• Jakob J, Hentschel L, Richter S, Kreisel I, Hohenberger P, Kasper B, Andreou D, Pink D, Schmitt J, Schuler MK, Eichler M. Transferability of Health-Related Quality of Life Data of Large Observational Studies to Clinical Practice: Comparing Retroperitoneal Sarcoma Patients from the PROSa Study to a TARPS-WG Cohort. Oncol Res Treat. 2022;45(11):660-669. doi: 10.1159/000525288. Epub 2022 Jun 14.

  PMID: 35700716 BACKGROUND

• MacNeill AJ, Fiore M. Surgical morbidity in retroperitoneal sarcoma resection. J Surg Oncol. 2018 Jan;117(1):56-61. doi: 10.1002/jso.24902. Epub 2018 Jan 3.

  PMID: 29314041 BACKGROUND

• Bonvalot S, Raut CP, Pollock RE, Rutkowski P, Strauss DC, Hayes AJ, Van Coevorden F, Fiore M, Stoeckle E, Hohenberger P, Gronchi A. Technical considerations in surgery for retroperitoneal sarcomas: position paper from E-Surge, a master class in sarcoma surgery, and EORTC-STBSG. Ann Surg Oncol. 2012 Sep;19(9):2981-91. doi: 10.1245/s10434-012-2342-2. Epub 2012 Apr 3.

  PMID: 22476756 BACKGROUND

• Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.

  PMID: 26727100 BACKGROUND

• Hettler M, Scharpf KR, Eich A, Albertsmeier M, Dupree A, Hetjens S, Harbrucker M, Menge F, Betzler A, Hohenberger P, Jakob J. Multicentre prospective non-interventional study protocol for evaluating surgical strategies for Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q). BMJ Open. 2025 Dec 30;15(12):e102015. doi: 10.1136/bmjopen-2025-102015.

  PMID: 41469069 DERIVED

Related Links

• The study is supported by the Association of Surgical Oncology of the German Surgical Society that provides some information on the study on their website

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jens Jakob, Prof.

  Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Jakob, Prof.

CONTACT

+49 621 383 2447; Jens.Jakob@umm.de

Madelaine Hettler, Dr.

CONTACT

madelainehenny.hettler@umm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Sarcoma Surgery and Sarcoma Center Mannheim, Heidelberg University

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 24, 2025
• Study Start: January 27, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12); CH (1)