Colorectal Resections in Patients With Retroperitoneal Sarcoma

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas [Срок оценки: immediately after the surgery]

Вторичные конечные точки (5)

• Postoperative complications associated with resections and reconstructions of the bowel [Срок оценки: up to 90 days after surgery]
• Assessment of quality of life after colorectal resections in the context of RPS resections [Срок оценки: through study completion, an average of 1 year]
• Assessment of changes in bowel function after resection of retroperitoneal sarcomas [Срок оценки: through study completion, an average of 1 year]
• Identification of problems and needs of RPS patients [Срок оценки: 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 [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Absence of consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 15 центров

• Sarcoma Center of University Medical Center Mannheim — Mannheim
• University Medical Center Goettingen — Göttingen
• Helios Hospital Berlin-Buch — Berlin
• University Hospital Koeln — Cologne
• University Medical Center Dresden — Dresden
• University Medical Center Erlangen — Erlangen
• University Medical Center Greifswald — Greifswald
• University Medical Center Halle — Halle
• … и ещё 7 центров

Швейцария · 1 центр

• Sarcoma Center University of Basel — Basel

Публикации

• 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
• 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
• 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
• 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 W PMID 26727100
• 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):e10 PMID 41469069

Идентификаторы

NCT: NCT06943612 · 2024-562 · DRKS00034135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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