Retroperitoneal Sarcoma, Sarcoma, Soft Tissue
Conditions
Keywords
Soft tissue sarcoma, Retroperitoneal Sarcoma, Sarcoma Surgery, Stoma, Colorectal resection
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.
Interventions
None listed
Sponsors
Heidelberg University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas | immediately after the surgery | Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications associated with resections and reconstructions of the bowel | 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) |
| Assessment of quality of life after colorectal resections in the context of RPS resections | through study completion, an average of 1 year | Assessment of quality of life after using the EORTC QLQ - C30 (Version 3.0) questionnaires) |
| Assessment of changes in bowel function after resection of retroperitoneal sarcomas | through study completion, an average of 1 year | Assessment of the bowel function using the EORTC QLQ - CR29 questionnaire |
| Identification of problems and needs of RPS patients | 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 |
| 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 | 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 |
Countries
Germany, Switzerland
Contacts
CONTACTJens Jakob, Prof.
CONTACTMadelaine Hettler, Dr.
PRINCIPAL_INVESTIGATORJens Jakob, Prof.
Sarcoma Unit, Department of Surgery, University Medical Center Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
Outcome results
None listed