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


Phase 4
18 Years
N/A
Not Enrolling
Both
Rectal Cancer, Adenocarcinoma

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

morbidity

Outcome Description:

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

Outcome Time Frame:

30 days

Safety Issue:

No

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

SILS rectal cancer

NCT ID:

NCT01579721

Start Date:

September 2011

Completion Date:

October 2012

Related Keywords:

  • Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

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