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NCT Number: NCT06943612

Colorectal Resections in Patients With Retroperitoneal Sarcoma

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.

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Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Retroperitoneal Sarcoma Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sarcoma Center of University Medical Center Mannheim, Mannheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas

    Time frame: immediately after the surgery

    Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis

Secondary outcomes

  1. Postoperative complications associated with resections and reconstructions of the bowel

    Time frame: 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)

  2. Assessment of quality of life after colorectal resections in the context of RPS resections

    Time frame: through study completion, an average of 1 year

    Assessment of quality of life after using the EORTC QLQ - C30 (Version 3.0) questionnaires)

  3. Assessment of changes in bowel function after resection of retroperitoneal sarcomas

    Time frame: through study completion, an average of 1 year

    Assessment of the bowel function using the EORTC QLQ - CR29 questionnaire

  4. Identification of problems and needs of RPS patients

    Time frame: 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

  5. Determination of patient-, tumor- and treatment-related factors influencing the above-mentioned primary and secondary study objectives

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jens Jakob, Prof.

CONTACT

[email protected]

+49 621 383 2447

Madelaine Hettler, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: COLOSARC-Q

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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