Objective: To compare patient outcome following standard of care (laparoscopic right hemicolectomy) and an alternative, established, recognized therapy (SILS right hemicolectomy) for the treatment of right colonic tumors.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
5 year cancer free survival
Secondary outcome
* Lymph node yield
* Histopathological grade of specimen
* Conversion rate
* 30 day mortality
* operative time
* pain scores (visual analog scale)
* cosmesis satisfaction
* early morbidity- wound/respiratory / urinary sepsis, thromboembolic,
cardiorespiratory, anastomotic leak, intra-abdominal abscess
* Intravenous narcotic/ oral analgesic requirements
* Resumption of intestinal function/ diet
* Duration to discharge home
* Return to normal activity
Background summary
Rationale: Current evidence regarding the optimal surgical approach to
potentially curable right colonic cancer is based on numerous, well designed
randomised controlled clinical trials. Currently, eminence based opinion
suggests that an alternative surgical technique, single incision laparoscopic
surgery (SILS), may improve short and long term outcomes after minimally
invasive right colonic resection. A true, prospective analysis comparing
standard of care (laparoscopic right hemicolectomy) and this "new"
therapy(SILS) has yet to be published.
Study objective
Objective: To compare patient outcome following standard of care (laparoscopic
right hemicolectomy) and an alternative, established, recognized therapy (SILS
right hemicolectomy) for the treatment of right colonic tumors.
Study design
The study will be an international multi-centred, randomized controlled trial.
Intervention
Group A will undergo a single incision laparoscopy right hemicolectomy and
group B will undergo a standard of care aparoscopic right hemicolectomy
Study burden and risks
Patients* post-operative course will be carefully recorded and they will be
asked some questions on a daily base at the time of the hospital stay,
including a visual analogue scale (VAS) for pain.
Outpatient follow up will be similar to regular patients; at 3 and 12 months.
There they will be asked to fill out the Short Form 36 (SF-36) Quality of Life
survey. At 2 and 5 years postoperatively patients will be contacted by
telephone in order to assess long-term follow-up, and to fill out a SF-36.
Meibergdreef 9
1105 AZ Amsterdam Zuidoost
NL
Meibergdreef 9
1105 AZ Amsterdam Zuidoost
NL
Listed location countries
Age
Inclusion criteria
1. Age 18-85 years
2. Histologic confirmation of right colonic cancer
3. Informed consent
Exclusion criteria
1. Inability to give informed consent (e.g. dementia)
2. Previous midline laparotomy incision
3. T4 tumour diagnosed on pre-operative imaging or intra-operatively
4. Previous pelvic irradiation
5. FAP/ HNPCC
6. Colonic carcinoma against a background of ulcerative colitis.
7. Emergent surgery for perforated/obstructing right colonic cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01319890 |
| CCMO | NL37218.018.11 |