To divert or not to divert
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To divert or not to divert after LAR. John H Marks MD and Rahila Essani MD Chief, Section of Colon and Rectal Surgery Main Line Health System. Introduction. Anastomotic leak is perhaps the most devastating complication after colorectal surgery

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To divert or not to divert after LAR

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To divert or not to divert after lar

To divert or not to divert

after LAR

John H Marks MD and RahilaEssani MD

Chief, Section of Colon and Rectal Surgery

Main Line Health System


Introduction

Introduction

  • Anastomotic leak is perhaps the most devastating complication after colorectal surgery

  • Leads to significant morbidity and mortality

  • Clinical anastomotic leak rate after anterior resection 2.9-19%

Rullier et al Br J Surg 1998


To divert or not to divert after lar

Introduction

  • Reported mortality rate for anastomotic

    leak 10% to 32%

  • associated with increased local recurrence and diminished survival

  • Bokey et al DCR 1995

  • Walker et al Ann Surg 2004

  • McArdle et al Br J Surg 2005

  • Pickleman J et al J Am Coll Surg 1999


Definition of anastomotic leak

Definition of Anastomotic leak

  • No uniformly accepted definition in the literature.

  • In a review of 97 studies from 1993 to 1999, 56 differentdefinitions of what

    constitutes an anastomotic leak were described*

* Bruce J et al Br J Surg 2001


Definition of anastomotic leak1

Definition of Anastomotic leak


Risk factors for anastomotic leak

Risk Factors for Anastomotic leak

Low Anastomosis and Male

* Kingham et al JACS 2008


What about radiation

What about radiation

  • Only retrospective studies looking at relationship between radiation and leak

  • Inconclusive data about whether preoperative irradiation leads to higher leak rates

  • Previous abdominal or pelvic irradiation was a risk for leak on univariate analysis for anastomotic leak, in 707 patients who underwent colorectal resection

Inconclusive “data”:

but come on…definitely a risk

Mortensen et al Best Pract Res Clin Gastroenterol 2004

Alves et al World Journal of Surgery 2002


Defunctioning stoma

Defunctioning stoma

  • Used in up to 73% of rectal cancers

  • Absence of defunctioning stoma is reported as a risk factor in retrospective reviews

  • Lower leakage rates have not been demonstrated with defunctioning stoma

Heald RJ et al World J Surg 1992

Peeters et al Br J Surg 2005

Gastinger et al Br J Surg 2005


Diversion cost to the patient

Diversion: Cost to the patient

  • Routine creation of a stoma will reduce the

    quality of life in the subgroup in whom no

    complications would occur

  • Stoma morbidity is reported to be 30%

  • Stoma closure leads to second hospital stay and additional costs

Gooszen et al Br J Surg 1998

Kooperna et al Arch Surg 2003


Benefit to the patient of diversion

Benefit to the patient of diversion

  • No good long term data on functional results of anastomosis after pelvic sepsis

    • Multiple studies indicate function better without pelvic sepsis

  • Increased risk of local and metastatic recurrence after leak

Laurent et al J Am Coll Surg 2006


Methods

Methods

  • 1/1996 12/1998- 70 patients in Australia

  • 19 defunctioning stoma

  • 51 without stoma

  • Direct patient care costs

    -laboratory resources

    -diagnostic imaging

    -endoscopy

    -supplies

    -drugs

    -operating room costs + devices in OR


Methods1

Methods

  • mean of these costs was calculated per day of hospital and operation time for calculation of cost-effectiveness data

  • Costs instead of charges were used

  • Main outcome measure

    – anastomotic leak rate


Results

Results


Results1

Results

  • Over all major difference in mean costs of treatment between an LAR carried out with or without a defunctioning stoma (€13985 vs €10391; P.001)

  • mean costs of treatment 5-fold higher with anastomotic leak (€42250) as compared to LAR without a stoma and without leak (€8400; P.001)


Cost analysis

Cost Analysis

best-case scenario

Costeffectiveness ratio of €158705/ leak avoided with defunctioning stoma

worst-case scenario

2.5-fold higher overall costs


Methods2

Methods

  • Relevant retrospective studies included in the systematic review

  • RCTs included in meta-analysis reporting

    -# of clinically relevant anastomotic leaks

    -# reoperations due to leaks


Systematic review

Systematic review

  • 1/1966 to 9/ 2007: 70 - 2729 patients

  • 3 categories of studies on use of stoma

    -Selective usage

    -Advocate Routine use

    -Reject use of stoma


Defunctioning stoma1

Defunctioning stoma

  • In non-randomized studies:

    Selection bias

    favors surgery without a stoma

    • Only best patients are not diverted

  • Selective creation of a stoma when complications are anticipated.


Example problem eea misfire

Example Problem: EEA Misfire


To divert or not to divert after lar

Selective stoma Studies

Stoma is not recommended

use for high risk patients


Studies rejecting use of defunctioning stoma

Studies Rejecting use of Defunctioning stoma

higher leak rates in stoma groups

routine use of a diverting stoma in LAR is not

advisable


Studies advocating diversion

Studies Advocating Diversion

Stoma prevents clinical leak

Stoma protects but doesn’t prevent leak


Conclusion

Conclusion

  • Included all anterior resections

  • No clear consensus from non-randomized studies

    - Due to selection bias


Methods3

Methods

  • Only included low anastomoses

  • Total 26 studies 1983-2008

    -22 non-randomized

    -4 RCTs

    -1 excluded

  • Meta-analysis included total 11429 patients


Methods4

Methods

  • 4 RCTs

    -358 patients

    -178 stoma group

    -180 non-stoma group

  • Non-randomized studies

    -11071 patients

    -4452 stoma group

    -6619 non-stoma group


Clinical leak rates in non randomized studies

Clinical leak rates in non-randomized studies

Significantly lower leak rates in stoma group

Meta-analysis of clinical leak rate in stoma versus non-stoma groups in non-randomized studies


Reoperation rates in non randomized studies

Reoperation rates in non-randomized studies

Significantly lower in stoma group

Meta-analysis of clinical leak rate in stoma versus non-stoma groups in non-randomized studies


Mortality rates in non randomized studies

Mortality rates in non-randomized studies

Significantly higher mortality in non-diverted group

Meta-analysis of mortality rate related to leakage in stoma versus non-stoma groups in non-randomized studies


Clinical leak rate in rct studies

Clinical leak rate in RCT studies

Over all higher leak rates in non diverted group

All had higher leak rates in non-stoma group but only one statistically significant

Meta-analysis of clinical leak rate in stoma versus non-stoma groups in randomized controlled trials


Reoperation rate in rct studies

Reoperation rate in RCT studies

Over all reoperation rates in non stoma group

All had higher reop rates in non-stoma group but only one statistically significant

Meta-analysis of reoperation rate in stoma versus non-stoma groups in randomized controlled trials


Mortality rates in rct studies

Mortality rates in RCT studies

No significant difference

Meta-analysis of mortality rate in stoma versus non-stoma groups in randomized controlled trials


To divert or not to divert after lar

Annals of Surgery Vol 246 August 2007


Methods5

Methods

  • 21 hospitals in Sweden participated in the REctal Cancer Trial On DEfunctioning Stoma (RECTODES)

Annals of Surgery Vol 246 August 2007


Inclusion criteria

Inclusion criteria

  • biopsy proven rectal cancer at 15 cm

  • estimated survival of 6 months

  • Intraoperative inclusion criteria

    -anastomosis at 7cm

    -negative air leak test

    -intact anastomotic stapler rings

    -absence of major intraoperative event

Randomization intraop

Annals of Surgery Vol 246 August 2007


Anastomotic leak

Anastomotic leak

  • Clinical:

    -Peritonitis

    -Rectovaginal fistula

    -Pelvic abscess without radiologic evidence

  • Leakage was verified by:

    -Clinical (digital palpation, inspection of drain contents)

    -Endoscopic (rigid rectoscopy, flexible sigmoidoscopy)

    -Radiologicinvestigations (rectal contrast study, CT)

  • Excluded:

    -Radiologically proven leak without clinical symptoms

Annals of Surgery Vol 246 August 2007


Results2

Results

  • From1999- 2005, 821 Anterior resections performed by 21 hospitals

  • 234(28.5%) patients randomized

    -116 defunctiong stoma

    -118 no stoma

    Preoperative radiation

    -79% of 234

  • The total rate of symptomatic anastomotic leak was 19.2% (45 of 234 patients)


Results3

Results

No difference

ASA

Gender

BMI

XRT

Level


Results4

Results

Defunctioning stoma 3.4X less likely to have a leak

  • Leak rate :

    -10.3% (12/116) defunctioning stoma

    -28.0% (33/118) no stoma


Results5

Results

  • 40% of the leaks identified after discharge on median POD# 24 (range13-72)

  • Urgent Reoperation

    6% of defunctioning stoma group

    23.4% of no stoma group


Results6

Results


Conclusions

Conclusions

  • Presence of defunctioning stoma signficantly decreases anastomotic leak rate

  • Need for urgent reoperation is increased in non-diverted group

Higher leak rate without stoma


Conclusion1

Conclusion

  • Significantly decreased leak and reoperation rates in non-stoma group in both randomized and non-randomized studies

  • Mortality rates lower in non-stoma group in non-randomized studies only


To divert or not to divert after lar

  • Two most common risk factors identified

    - Level of anastomosis

    - Male sex


Conclusion2

Conclusion

  • The benefits of stoma in decreasing the rate of anastomotic leak and its consequences, should be balanced against the morbidity of the stoma itself


Who should be diverted

Who should be diverted

  • Obese

  • Low anastomsis

  • Males

  • Irradiated pelvis


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