Laparoscopic Versus Open Left Colonic Resection

Università Vita-Salute San Raffaele

Status and phase: Completed; Phase 3

Conditions: Benign Disease; Colon Cancer

Treatments: Procedure: open left colonic resection; Procedure: laparoscopic left colonic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT00894725

hmsxLPS09

Details and patient eligibility

About

The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

Full description

The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• suitability to elective surgery

Exclusion criteria

• cancer infiltrating adjacent organs assessed by computed tomography
• cardiovascular dysfunction (New York Heart Association class > 3)
• respiratory dysfunction (arterial pO2 < 70 mmHg)
• hepatic dysfunction (Child-Pugh class C)
• ongoing infection
• plasma neutrophil level < 2.0x109/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

268 participants in 2 patient groups

LPS

Experimental group

Description:

laparoscopic left colonic resection

Treatment:

Procedure: laparoscopic left colonic resection

Open

Active Comparator group

Description:

open left colonic resection

Treatment:

Procedure: open left colonic resection