Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Phase 4

Completed

• Conditions: Rectal Cancer; Adenocarcinoma
• Interventions: Procedure: Single Incision Laparoscopic Surgery

• Registration Number: NCT01579721
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-03
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SILS-group	Single Incision Laparoscopic Surgery	20 patients undergoing Single Incision Laparoscopic Surgery

Primary Outcome Measures

Name	Time	Method
morbidity	30 days	The purpose of this study is to compare 30-days postoperative morbidity between the two groups

Secondary Outcome Measures

Name	Time	Method
immunology	72 hours postoperatively	to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups
postoperative outcome	5 days postoperatively	to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups.
oncology	30 days	Comparison of the oncological results (quality of specimen, completeness of mesorectal fascia, circumferential resection margin, number of harvested lymphnodes, TNM-classification) between the two groups.

Trial Locations

Locations (1)

Department of Gastroentestinal Surgery, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark