The "SPARCOL" Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Combined Endoscopic Laparoscopic Surgery (CELS): The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis. Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress response.

Standard resection: In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Study summary

Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.

Eligibility

Primary outcome measure(s)

• Change in patient-reported postoperative recovery - Quality of Recovery 15 — Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30
  Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.

Trial sites (3)

More Zealand University Hospital trials in Denmark

Other trials for the same condition