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NCT Number: NCT06050447

Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.

Recruiting

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Key information

Conditions

Colorectal Cancer Anastomotic Leak Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Adenocarcinoma Colorectal Neoplasms Colorectal Neoplasms Malignant Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Adenocarcinoma Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baltic Federal University

Kaliningrad, Kaliningrad Oblast, 236041, Russia

Location status: Recruiting

Location contact

Mikhail A Agapov, PhD/MD

PRINCIPAL_INVESTIGATOR

Tatyana N Garmanova, PhD/MD

SUB_INVESTIGATOR

Viktor V Kakotkin, MD

CONTACT

[email protected]

+74012595071

Viktor V Kakotkin, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven primary adenocarcinoma of bowel;
  • All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
  • Signed informed consent with agreement to attend all study visits;

Exclusion criteria

  • Unresectable tumor or contradictions to surgery;
  • Indications for chemotherapy or radiation therapy prior to surgery;
  • Patient withdrawal from the trial or loss of follow-up;
  • Emergent operation;
  • Pregnancy.

Treatment and study plan

Right Hemicolectomy

Procedure

Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon

Left hemicolectomy

Procedure

Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.

Sigmoid colon resection

Procedure

Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon

Anterior resection of the rectum

Procedure

AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum

Low anterior resection of the rectum

Procedure

LAR is appropriate for tumors located in the middle and low rectum

Abdominoperineal resection

Procedure

APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles

Total Colectomy

Procedure

Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors

Primary outcomes

  1. Anastomotic leakage rate

    Time frame: 3 months after surgery

    Anastomotic leakage rate after colorectal resection.

    AL is confirmed by one or more of the following conditions:

    • fecal discharge from the pelvic drainage at any time after surgery
    • rectovaginal fistula defined as fecal or mucus discharge from the vagina
    • pelvic sepsis as defined by the collection of pus/ fecal material in the pelvis documented by CT scan
    • contrast present outside of the anastomosis as seen by X-Ray contrast enema proctography or CT contrast enema proctography

  2. Mortality rate

    Time frame: 3 years after surgery

    the overall mortality after colorectal cancer surgery

Secondary outcomes

  1. 30-day complication rate

    Time frame: 30 days after surgery

    The number of patients with complications after colorectal resection. All complications will be assessed according to the Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).

    Grade I - Any deviation from the normal postoperative course without the need for treatment.

    Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Grade III - Requiring surgical, endoscopic or radiological intervention

    • IIIa - Intervention not under general anesthesia
    • IIIb - Intervention under general anesthesia Grade IV - Life-threatening complication requiring IC/ICU-management
    • IVa - single organ dysfunction (including dialysis)
    • IVb - multiorgandysfunction Grade V - Death of a patient

  2. Recurrence rate

    Time frame: 3 years after surgery

    All cases of colorectal cancer recurrence

  3. Cancer-specific survival

    Time frame: 3 years after surgery

    The number of patients survived within 3 years after the diagnosis

  4. Recurrence-free survival

    Time frame: 3 years after surgery

    The number of patients without cancer recurrence within 3 years after surgery

Study contacts

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

Tatiana N Garmanova, PhD

CONTACT

[email protected]

+79773429249

Sponsors and collaborators

Lead sponsor

Immanuel Kant Baltic Federal University

Other

Collaborators

  • Center of Endourology "Endocenter"

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

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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