1. Intra-operative complications of laparoscopic colonic surgery
Tarik Sammour Arman Kahokehr Sanket Srinivasa Ian P Bissett Andrew G Hill

2. 40% of all colonic resections in the US between 2005 and 2006.
600,000 colectomies per year performed in the US => 0.25 million colectomies laparoscopic

3. Lap Colectomy: The evidence
Level 1 supporting evidence is available
4 Cochrane reviews
30+ published RCTs vs open surgery
Modest but measurable benefit
Reduced day stay (1 day)
Earlier GI function (1 day)
Cosmesis
Intra-operative Complications?
Despite all this evidence, the intra-operative complication rate has never been formally assessed in systematic reviews, and all the published RCTs are underpowered to detect rare events.

4. ALCCaS: Australasian RCT
601 patients randomised to lap vs open colectomy
Recovery
Flatus 0.3 days earlier (p 0.027)
Discharge 7 vs 8 days (p )
Complications
Intra-op vs 3.7% (p 0.001)
In 2008 the ALCCaS trial was published in Annals of Surg.

5. The importance of these results were further magnified by an important publication that followed shortly after. This report by the Dutch Health Inspectorate entitled “Risks of minimally invasive surgery underestimated” found a surprisingly high rate of reported intra-operative adverse events on a national scale. All three authors are colorectal surgeons.

6. than open colorectal resection?
Study Question
Does laparoscopic colorectal resection have a higher intra-operative complication rate
than open colorectal resection?

7. Methods: Search Cochrane Highly Sensitive Search Strategy
No language restriction
Two independent researchers
Consensus with senior author
Exclusion criteria
Non-randomised trials
Hand-assisted laparoscopic resection
Trials that excluded conversions

8. Methods: Data Validity assessment Data extraction
Bias assessed using Cochrane Collaboration tool
Two independent researchers
Masked to the journal / article title
Data extraction
Corresponding authors contacted for raw data
Complications counted per-event
Complications categorised
Bowel injury serosal / full thickness
Haemorrhage requiring transfusion/conversion
Solid organ injury requiring intervention
Total
Masked to the journal title, article title and authors of the publications using unformatted versions of the manuscripts that had any identifying information deleted.

9. Methods: Statistical Analysis
Review Manager Version 5.0
PETO odds ratio
95% confidence intervals
Fixed effects model
This model chosen because:
Best assessment of infrequent events
Standard Mantel-Hanzel odds ratio analysis also performed to test robustness of any findings

11. Results: Publication bias

12. Results: Study Characteristics
Ten RCTS (all 4 major multi-centre trials included)
4,055 patients in total
2,159 Laparoscopic
1,896 Open
Surgical indication
Colorectal cancer 8 studies
Sigmoid diverticulitis 1 study
Ileocaecal Crohns 1 study
Credentialing
Required prior to enrolment in 7 out of 10 studies
Credentialing => accounting for 91% of the included patients
Overall studies were of moderate quality with minimal apparent publication bias.

13. Results: Total complications
7.92% 5.43%
NNH = 40
NNH = 40

14. Results: Bowel injury

15. Results: Haemorrhage

16. Results: Solid organ injury

17. Results: Subset analyses
Colon / Rectal cancer resections (8 studies)
Total complications OR 1.42, P = 0.009
Bowel injury OR 1.93, P = 0.020
Colon cancer resections (4.5 studies)
Total complications OR 1.55, P = 0.009
Bowel injury OR 2.28, P = 0.006
Per-patient (rather than per-event, 7 studies)
Total complications OR 1.54, P = 0.010

18. Conclusion
Laparoscopic colorectal surgery has a significantly higher intra-operative complication rate than equivalent open surgery (NNH = 40).
This new information needs to be incorporated into the informed consent process, and any benefits gained need to be balanced against these potential risks, bearing in mind that this data is mainly from tertiary specialised units performing procedures on highly selected patients, and that in different settings or in unselected patients the real complication rate may actually be higher.
Operations in all the RCTs included were performed by established laparoscopic surgeons in accredited colorectal centers. In fact, in 7 out of the 10 RCTs (accounting for 91% of included patients) the operating surgeons underwent some form of credentialing which attempted to control for the learning curve effect.
The operations were performed on highly selected patients with those presenting acutely, with a transverse colon, synchronous, or invading neoplastic lesion being excluded from most studies.This raises a significant concern that less experienced surgeons operating on a broader range of patients may experience an even greater intra-operative complication rate than presently reported.
Since the absolute numbers of intra-operative complications are relatively low, it is highly likely that any sequelae would be masked by the much higher rate of minor and major post-operative complications after colorectal surgery, which is of the order of 20 – 40% in the included RCTs. Also, there is evidence that the rate of post-operative complications is highly influenced by peri-operative care practices which do not necessarily relate to intra-operative technique or course.

20. Results: Risk of Bias