Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Adenocarcinoma; Rectal Cancer

Treatments: Procedure: Single Incision Laparoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01579721

SILS rectal cancer

Details and patient eligibility

About

Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.

Design: randomized, prospective clinical study Patients: 40 patients

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years of age.
• ASA I-III.
• Tumor-location: maximum 15 cm from the anal verge.
• No involvement of neighbouring organs.
• No distant metastasis.

Exclusion criteria

• Linguistic, physical or psychological barriers precluding oral and written consent.
• History of intestinal surgery (excl. appendectomy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

SILS-group

Experimental group

Description:

20 patients undergoing Single Incision Laparoscopic Surgery

Treatment:

Procedure: Single Incision Laparoscopic Surgery

CLS-group

No Intervention group

Description:

20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer