Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01579721

Enrollment

Registered

2012-04-18

Start date

2011-09-30

Completion date

2012-10-31

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Adenocarcinoma

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

Interventions

PROCEDURESingle Incision Laparoscopic Surgery

Single incision laparoscopic surgery for rectal cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
morbidity	30 days	The purpose of this study is to compare 30-days postoperative morbidity between the two groups

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026