Clinical trial NCT06943612: Colorectal Resections in Patients With Retroperitoneal Sarcoma
Official title: Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma, Soft Tissue
Retroperitoneal Sarcoma
Keywords: Soft tissue sarcoma
Retroperitoneal Sarcoma
Sarcoma Surgery
Stoma
Colorectal resection
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Postoperative complications associated with resections and reconstructions of the bowel
timeFrame: up to 90 days after surgery
measure: Assessment of quality of life after colorectal resections in the context of RPS resections
timeFrame: through study completion, an average of 1 year
measure: Assessment of changes in bowel function after resection of retroperitoneal sarcomas
timeFrame: through study completion, an average of 1 year
measure: Identification of problems and needs of RPS patients
timeFrame: through study completion, an average of 1 year
measure: Determination of patient-, tumor- and treatment-related factors influencing the above-mentioned primary and secondary study objectives
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Sarcoma Center of University Medical Center Mannheim
state: BW
city: Halle
country: Germany
facility: University Medical Center Halle
city: Hannover
country: Germany
facility: Medical University of Hannover
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Basel
country: Switzerland
facility: Sarcoma Center University of Basel
Study officials:
affiliation: Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
name: Jens Jakob, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.