Factors Affecting the Results of Treatment of Patients With Colorectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImmanuel Kant Baltic Federal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Right hemicolectomy

    Procedure/Surgery

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

  • Left hemicolectomy

    Procedure/Surgery

    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/Surgery

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

  • Anterior resection of the rectum

    Procedure/Surgery

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

  • Low anterior resection of the rectum

    Procedure/Surgery

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

  • Abdominoperineal resection

    Procedure/Surgery

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

  • Total Colectomy

    Procedure/Surgery

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

Treatment groups

1,200 Participants
are divided into 4 treatment groups
Group A: Patients with right-sided colon cancer1 intervention
Group B: Patients with left-sided colon cancer2 interventions
Group C: Patients with rectal cancer3 interventions
Group D: Patients with right- and left-sided colon cancer (primary multiple cancer)1 intervention

Trial outcomes

Primary outcomes

1

Anastomotic leakage rate

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

Time frame
3 months after surgery
2

Mortality rate

the overall mortality after colorectal cancer surgery

Time frame
3 years after surgery

Secondary outcomes

1

30-day complication rate

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

Time frame
30 days after surgery
2

Recurrence rate

All cases of colorectal cancer recurrence

Time frame
3 years after surgery
3

Cancer-specific survival

The number of patients survived within 3 years after the diagnosis

Time frame
3 years after surgery
4

Recurrence-free survival

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

Time frame
3 years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immanuel Kant Baltic Federal University

Lead sponsor

Center of Endourology "Endocenter"

Collaborator