Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer

NCT04324567 | Completed

• 1 other identifier: 2019/810
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.

Conditions

Locally Advanced Rectal Cancer; Abdominoperineal Resection

Keywords

Microdialysis; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery

  CRP will be measured prior to surgery as well as on a daily basis the first 4 postoperative days. Peak values of CRP will be compared between patients undergoing open versus robot-assisted surgery.

  December 2022

Secondary Outcomes (7)

• Overall survival at 1 year follow up after surgery

  December 2024

• Progression-free survival at 1 year follow up after surgery

  December 2024

• Operating time in minutes

  December 2023

• Hospital length of stay in days after primary surgery

  December 2023

• Postoperative deep pelvic surgical site infection within 30 days after primary surgery

  December 2023

Other Outcomes (3)

• Monitoring inflammatory mediators in blood after neoadjuvant CRT and subsequent APR for LARC.

  December 2023

• Monitoring inflammatory mediators in pelvic drain fluid after neoadjuvant CRT and subsequent APR for LARC.

  December 2023

• Monitoring intermediate metabolites in the remnant muscular tissue of the pelvis floor in up to 10 patients with microdialysis catheters after neoadjuvant CRT and subsequent APR for LARC.

  December 2023

Study Arms (2)

APR-open

Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparotomy.

APR-robot

Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparoscopic robot assisted technique.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer who receive radiotherapy \>25 Gy prior to surgery.

You may qualify if:

• Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
• operation with APR with laparoscopic robot assisted technique.
• have accepted and signed the consent form.

You may not qualify if:

• APR for other reasons

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

The Norwegian Radium Hospital Oslo University Hospital

Oslo, 0379, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peritoneal fluid - daily samples as long as a pelvic drain is indicated. Regularly standard blood samples. Daily EDTA-plasma until post operative day 4, or longer if clinically indicated.

Study Officials

• Ebbe B Thorgersen, MD PhD

  Surgeon, The Department of Gastroenterological Surgery, The Norwegian Radium Hospital, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 27, 2020
• Study Start: October 9, 2019
• Primary Completion: March 5, 2022
• Study Completion: March 5, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

NO (1)