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Clinical Trials/NCT01579721
NCT01579721
Completed
Phase 4

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

Hvidovre University Hospital1 site in 1 country40 target enrollmentSeptember 2011
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ConditionsRectal CancerAdenocarcinoma

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
Hvidovre University Hospital
Enrollment
40
Locations
1
Primary Endpoint
morbidity
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katrine Kanstrup Aslak

MD

Hvidovre University Hospital

Eligibility Criteria

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).

Outcomes

Primary Outcomes

morbidity

Time Frame: 30 days

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

Secondary Outcomes

  • immunology(72 hours postoperatively)
  • postoperative outcome(5 days postoperatively)
  • oncology(30 days)

Study Sites (1)

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