Colorectal Resections in Patients With Retroperitoneal Sarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeidelberg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Absence of consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Patients with primary, retroperitoneal sarcomas who underwent surgery with colorectal resection
Trial outcomes
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
Time frame
immediately after the surgerySecondary outcomes
1
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)
Time frame
up to 90 days after surgery2
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)
Time frame
through study completion, an average of 1 year3
Assessment of changes in bowel function after resection of retroperitoneal sarcomas
Assessment of the bowel function using the EORTC QLQ - CR29 questionnaire
Time frame
through study completion, an average of 1 year4
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
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov