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Laparoscopic Versus Open Right Colectomy for Right Colon Cancer

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorLarissa University Hospital

About this trial

The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. The comparison of the two techniques will include endpoints regarding the quality characteristics of the specimens and the oncological results. In addition, the effectiveness of the two methods will be evaluated in terms of the early and late postoperative period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed right colon cancer (cecum, ascending colon, hepatic flexure)

Surgical resection based on the CME principles

Patient 18 to 90 years old

American Society of Anesthesiologists score ≤III

Disqualifiers

Non elective operation (hemorrhage, perforation, obstruction)

Locally advanced disease (T4)

Distant metastases (Stage IV)

American Society of Anesthesiologists ≥IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic right colectomy

    Procedure/Surgery

    Resection of the ascending colon via a laparoscopic approach, adhering to the CME principles

  • Open right colectomy

    Procedure/Surgery

    Resection of the ascending colon via an open approach, adhering to the CME principles

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Laparoscopic right colectomyExperimental treatment 1 intervention
Group B: Open right colectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mesocolic Resection Plane

Occurrence of Mesocolic Resection Plane. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
1 month postoperatively

Secondary outcomes

1

Open Conversion

Occurrence of Open Conversion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
Intraoperative period
2

Operative Time

The total operative time will be recorded. Measurement unit: minutes

Time frame
Intraoperative period
3

Type of Anastomosis

Occurrence of Stapled or Handsewn Anastomosis. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
Intraoperative period
4

Intraoperative Transfusion

Occurrence of Intraoperative Transfusion. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

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

Larissa University Hospital

Lead sponsor

Source ClinicalTrials.gov
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