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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00034135 | Other Identifier | German Register of Clinical Studies (DRKS) |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications associated with resections and reconstructions of the bowel | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Jakob, Prof. | Contact | +49 621 383 2447 | Jens.Jakob@umm.de | |
| Madelaine Hettler, Dr. | Contact | madelainehenny.hettler@umm.de |
| Name | Affiliation | Role |
|---|---|---|
| Jens Jakob, Prof. | Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Center of University Medical Center Mannheim | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35700716 | Background | 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. | |
| 29314041 |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Assessment of quality of life after colorectal resections in the context of RPS resections | 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 | 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 | 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 | Determination of the influence of the following patient-, tumor- and treatment-related factors on the above-mentioned primary and secondary study objectives:
| through study completion, an average of 1 year |
| Helios Hospital Berlin-Buch | Recruiting | Berlin | Germany |
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| University Medical Center Dresden | Recruiting | Dresden | Germany |
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| University Medical Center Erlangen | Recruiting | Erlangen | Germany |
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| University Medical Center Halle | Recruiting | Halle | Germany |
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| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
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| Medical University of Hannover | Recruiting | Hanover | Germany |
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| Heidelberg University Hospital | Recruiting | Heidelberg | Germany |
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| University Hospital Magdeburg | Recruiting | Magdeburg | Germany |
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| LMU Hospital | Recruiting | München | Germany |
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| University Medical Center Tübingen | Recruiting | Tübingen | Germany |
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| University Medical Center Ulm | Recruiting | Ulm | Germany |
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| Sarcoma Center University of Basel | Recruiting | Basel | Switzerland |
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| 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. |
| 22476756 | 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. |
| 26727100 | 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. |
| 41469069 | Derived | 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. |