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S. S. Hill and A. Damle
should weigh “patient factors, intraoperative factors, and surgeon preference.” This chapter explores the most recent literature published over the last 20years regarding operative approach (i.e. Hartmann’s procedure vs. primary anastomo­sis) should be chosen for patient management in the setting of acute complicated diverticulitis.
Search Strategy
A comprehensive search of PubMed and MedLINE databases were performed using the following MeSH terms: “diverticulitis, colonic,” “anastomosis, surgical,” “ileos­tomy,” “colectomy,” and “colostomy.” The search was limited to the last 20 years (January 2002– August 2022) and non-English studies were excluded. Only the most recent study was used if it was a continuation of the same study from the same institution. All article abstracts were reviewed as well as full text when a study potentially satised the inclusion criteria. The reference lists of included studies were manually reviewed to identify additional studies to incorporate as appropriate. Systematic reviews and meta-analyses were reviewed for their references but data were not used primarily. Studies using databases were excluded if they featured data from overlapping years and the studies with the most inclusive dates were chosen. The primary outcome evaluated was mortality (Table36.1). Secondary outcomes included major morbidity, stoma reversal rates, and morbidity associated with reversal. Each study was evaluated for its level of quality of evidence based on the GRADE approach [7].
Table 36.1 PICO Table
P (Patients) Patients with acute
complicated diverticulitis
I (Intervention) C (Comparator)
Hartmann procedure
Primary anastomosis
O (Outcomes) Primary: 30-day mortality
Secondary: 30-day morbidity, stoma reversal rate, reversal morbidity
36 Hartmann Procedure vs Primary Anastomosis forAcute Complicated Diverticulitis
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Results
The initial search revealed 72 hits for “diverticulitis” AND “ileostomy” or “colos­tomy” and 165 hits for “diverticulitis” and “surgical anastomosis.” All abstracts were reviewed for studies that compared Hartmann’s procedure to primary anasto­mosis (with and without diverting ileostomy). Studies were removed according to above exclusion criteria. A total of 21 studies were used in the nal analysis. There were four prospective multi-center randomized control trials, four prospective non­randomized series, nine retrospective series, and four retrospective database studies (Table36.2).
Table 36.2 Outcomes after index procedure of the analyzed studies
Post­operative major morbidity (%) after index procedure p-value
14
14^
44
ϑ
ϑ
0.02* Low
0.20 Very low
0.56 Low
Quality of Evidence
(continued)
Author (Year) Blair NP,
Germann E (2002) [12]
Mäkelä J etal. (2002) [13]
Zorcolo L etal. (2003) [14]
Regenet N etal. (2003) [15]
Constantinides VA etal. (2006) [16]
Richter S etal. (2006) [17]
Breitenstein S etal. (2007) [18]
Stumpf MJ etal. (2007) [19]
Vermeulen J etal. (2007) [20]
Zingg U etal. (2010) [21]
Mortality
Patients (n) Study type
RS 64 vs. 33 20 vs. 9 0.26 NR n/a Very low
RS 75 vs. 45 13 vs. 4 0.12 32 vs. 36 0.69* Low
RS 140 vs.
PS 33 vs. 27 12 vs. 11 NS NR n/a Moderate
PS 167 vs.
PS 36 vs. 5 60 vs. 11 0.007* NR n/a Very low
PS 30 vs. 30 17 vs. 10 0.69 37 vs. 30 0.58* Moderate
RS 30 vs. 36 17 vs. 0 0.03 33 vs.
RS 139 vs. 61 34 vs. 11 <0.01 33 vs. 13 <0.01 Low
RS 64 vs. 46 29 vs. 17 0.18 51 vs.
Hartmann’s
vs PA
176
248
(%) after index procedure p-value
20 vs. 6 <0.001 24 vs.
23 vs. 4 <0.001 22 vs. 19 0.46 Moderate
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Table 36.2
Author (Year) Trenti L etal.
(2011) [22] Mueller MH
etal. (2011) [23]
Binda GA etal. (2012) [8]
Gawlick U, Nirula R (2012) [24]
Masoomi H etal. (2012) [25]
Oberkoer CE etal. (2012) [11]
Alizai PH etal. (2013) [26]
Bridoux V etal. (2017) [9]
Cauley CE etal. (2018) [27]
Lambrichts DPV etal. (2019) [10]
Lee JM etal. (2019) [28]
All outcomes are provided as % of patients in the Hartmann’s procedure vs. % of patients in the primary anastomosis (p-value). NR = not reported. NS = non-signicant. Retrospective series (RS), Prospective non-randomized series (PS), Prospective multi-center randomized control trial (PM-RCT), Prospective single-center randomized control trial (PS-RCT). The * symbol denotes instances where p-value for comparisons were not reported; these were calculated using a two­tailed two-population z-test based on reported n in each cohort. When complications were reported by Clavien-Dindo scoring, those that were class IIIb-IV were considered major morbidities. Otherwise, a composite any-morbidity percentage is reported by the ^ symbol and composite sur­gical morbidity percentage is reported by the
(continued)
Post­operative
Mortality
Patients (n) Study type
RS 60 vs. 27 45 vs. 7 0.001 NR n/a Low
RS 26 vs. 47 27 vs. 4 0.008 46 vs. 30 0.16* Low
PM­RCT
RS­NSQIP
RS- NIS
PM­RCT
RS 72 vs. 26 25 vs. 12 0.18 NR n/a Low
PM­RCT
RS- NIS
PM­RCT
RS­NSQIP
Hartmann’s
vs PA
56 vs. 34 11 vs. 3 0.25 46 vs.
1678 vs.
340
56,866 vs.
3361
30 vs. 32 13 vs. 9 0.67 40 vs. 44 0.80 High
52 vs. 50 4 vs. 4 0.97* 14 vs.
65,084 vs.
2637
66 vs. 64 3 vs. 6 0.44 12 vs. 14 0.60 High
2915 vs.
239
(%) after index procedure p-value
6 vs. 8 NS NR n/a Low
5 vs 4 0.03 41 vs.
6 vs. 16 <0.001 23 vs. 32 <0.001 Low
8 vs. 3 0.01 55 vs.
ϑ
symbol.
major morbidity (%) after index procedure p-value
35^
39^
14^
49^
Quality of Evidence
0.38 Moderate
0.04 Low
0.93 High
0.06 Low
36 Hartmann Procedure vs Primary Anastomosis forAcute Complicated Diverticulitis
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It is important to note that quality of evidence for these studies varies from very low to moderate on the GRADE criteria. The randomized control trials [8–11] were all terminated early prior to meeting their a priori sample size calculations, ranging from 30%–56% of recruitment targets. Furthermore, there was wide variation in primary anastomosis technique in the randomized control trials with 66%- 100% of patients receiving diverting loop ileostomies. Then, the rest of the studies are retro­spective studies at institutional, multi-institutional, or large database levels and are subject to the inherent biases related to retrospective studies, especially those of patient selection.
401
Mortality
For the primary outcome of post-operative mortality, none of the randomized con­trolled trials showed a statistical difference. Two of four prospective series [16, 17], ve of nine retrospective series [14, 19, 20, 22, 23], and two retrospective database studies [25, 28] found higher mortality rates in the Hartmann’s group. However, using the National Inpatient Sample, Cauley CE etal. [27] found higher rate of mortality in their primary anastomosis group (16% vs. 6% in the Hartmann’s group, p< 0.001), which could be partially due to the primary anastomosis cohort being older, having higher Charlson Comorbidity Index scores, and have more patients belonging to Medicaid insurance status. The remaining eleven studies found no signicant difference in mortality rates.
Post-operative Morbidity
All four of the multicenter randomized controlled trials reported on the secondary outcomes. There were no signicant differences in post-operative morbidity after index procedure. Two of the four prospective series looked at post-operative mor­bidity and both failed to nd a signicant difference. Six of nine retrospective stud­ies reported data regarding post-operative morbidity and two studies observed less morbidity in the primary anastomosis group (24% in Hartmann’s vs. 14% in pri­mary anastomosis, p=0.02, [14] and 33% in Hartmann’s vs. 13% in primary anas­tomosis, p<0.01 [20]). Two of three retrospective database studies that reported morbidity data found differences in post-operative morbidity but in differing direc­tions; Cauley CE with 23% in the Hartmann’s cohort vs. 32% in the primary anas­tomosis cohort (p<0.001) using the NIS database but from 1998–2011 [27], while Masoomi H etal. observed 41% vs. 39% (p=0.04) also using the NIS database but from 2002–2007 [25].
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Stoma Reversal
Stoma reversal rates and post-operative morbidity are summarized in Table 36.3. Two multicenter randomized controlled trials showed higher rates of stoma reversal in the primary anastomosis cohorts (90% for ileostomy reversal vs. 58% for colos­tomy reversal [11] and 96% vs 58% [9]). Only Oberkoer etal. [11] found a signi­cant difference in rates of complications following stoma reversal (20% following colostomy reversal vs. 0% following ileostomy reversal). Of the prospective studies, only Breitenstein S. reported both colostomy and ileostomy reversal rates, nding 60% vs. 96% (p=0.001), respectively, but no signicant difference in post- operative morbidity following reversal. Only two retrospective series reported both reversal rates [22, 26], and the latter showed a signicant difference in rates (58% in Hartmann’s vs. 85% in primary anastomosis, p= 0.046). No retrospective series reported both colostomy and ileostomy reversal post-operative morbidity. Only ve studies reported data on combined morbidity from both procedures (index resection and stoma reversal; Table36.3). All of the studies showed that primary anastomosis had lower overall morbidity rates but all failed to achieve statistical signicance.
In recent years, multiple meta-analyses and systematic reviews on these studies have been published. Cirrochi etal. included three randomized controlled trials and found no statistically signicant permanent stoma rate, anastomotic leaks, but found lower rates of intra-abdominal abscess after primary anastomosis [29]. Gachabayov M etal. combined seventeen studies and found patients with primary anastomosis had lower mortality in patients (OR 0.38, p<0.001), organ/space surgical site infec­tions (OR 0.25, p=0.003), reoperation (OR 0.48, p=0.02), and ostomy non- reversal rates (OR 0.27, p=0.02) [30]. Ryan OK etal. analyzed twelve studies and found patients with primary anastomosis had lower rate of permanent stoma (RR 0.43, p=0.001), but no signicant differences in mortality or morbidity [31]. Lambrichts etal. evaluated eleven studies, including four randomized control trials, of patients with Hinchey III/IV diverticulitis comparing Hartmann procedure vs primary anas­tomosis and found no differences in mortality, morbidity, or re-intervention after index procedure but improved stoma reversal rates with primary anastomosis (OR
2.62, 95% CI 1.29–5.31) [32].
36 Hartmann Procedure vs Primary Anastomosis forAcute Complicated Diverticulitis
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p-value
Combined
major
morbidity
(%) after
both
procedures
30-day
major
morbidity
(%) after
reversal (HP
vs. PA) p-value
403
Stoma
reversal rate
(%) (HP vs.
PA) p-value
Patients (n)
HP vs. PA
Study type
Table 36.3 Stoma reversal rates procedure of the analyzed studies
Author (Year)
Mäkelä J etal. (2002) [13] RS 75 vs. 45 45 vs. NR n/a NR n/a NR n/a
Zorcolo L etal. (2003) [14] RS 140 vs. 176 39 vs. NR n/a 20 vs. NR n/a NR n/a
56 vs. 34 60 vs. 65 0.66 24 vs. 5 0.06 25 vs. 38 0.11*
PS 30 vs. 30 60 vs. 96 0.001 27 vs. 8 0.10 33 vs. 20 0.12*
Regenet N etal. (2003) [15] PS 33 vs. 27 69 vs. NA n/a 24 vs. NR n/a NR n/a
Richter S etal. (2006) [17] PS 36 vs. 5 50 vs. 100 0.17* NR n/a NR n/a
Breitenstein S etal. (2007)
[18]
Trenti L etal. (2011) [22] RS 60 vs. 27 27 vs. 60 0.14* NR n/a NR n/a
Binda GA etal. (2012) [8] PM-
30 vs. 32 58 vs. 90 0.01 20 vs. 0 0.046 50 vs. 44 0.80
RCT
PM-
Oberkoer CE etal. (2012)
RCT
[11]
Alizai PH etal. (2013) [26] RS 72 vs. 26 58 vs. 85 0.046 NR n/a NR n/a
52 vs. 50 65 vs. 96 <0.001* 9 vs. 3 0.32* 17 vs. 16 0.42
RCT
Bridoux V etal. (2017) [9] PM-
66 vs. 64 68 vs. 83 0.09 16 vs 3 0.06 48 vs. 36 0.29
PM-
RCT
Lambrichts DPV etal. (2019)
[10]
All outcomes are provided as % of patients in the Hartmann’s procedure vs. % of patients in the primary anastomosis (p-value). NR=not reported. NS=non-
signicant. Retrospective series (RS), Prospective non-randomized series (PS), Prospective multi-center randomized control trial (PM-RCT), Prospective single-
center randomized control trial (PS-RCT). The * symbol denotes instances where p-value for comparisons were not reported; these were calculated using a
two- tailed two-population z-test based on reported n in each cohort. When complications were reported by Clavien-Dindo scoring, those that were class IIIb-IV
were considered major morbidities.
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S. S. Hill and A. Damle
Recommendations Based ontheData
Primary anastomosis and diverting loop ileostomy in the setting of acute compli­cated diverticulitis is a safe procedure. There is no high-level evidence that there are differences in mortality or immediate post-operative morbidity between patients undergoing Hartmann’s procedure vs. primary anastomosis with diversion. Outcomes of meta-analyses have inconsistently demonstrated ndings of decreased mortality, intra-abdominal abscess, surgical site infection, and re-operation– all in favor of primary anastomosis. However, the key difference between the two cohorts lies in stoma reversal rates. Half of the randomized controlled trials showed a differ­ence with 90–96% of ileostomies being reversed vs. 58–65% of colostomies. Only one study showed a statistically signicant difference in major morbidity following reversal. Ultimately, decision making regarding Hartmann’s vs. primary anastomo­sis should be inuenced by patient comorbidities such as poorly controlled diabetes, immunosuppression, their ability to tolerate a potential leak, and overall patient presentation (e.g. septic shock, hemodynamic instability, vasopressor require­ment, etc.).
• Acute complicated diverticulitis patients with appropriate operative risk should
be considered for a primary anastomosis. (Grade of recommendation: moder-
ate; Quality of evidence: moderate).
The benet of diverting loop ileostomy in the setting of primary anastomosis has been more difcult to quantify. There are no randomized control trials comparing primary anastomosis with or without ileostomy in the setting of complicated diver­ticulitis. This stems from a fundamental lack of equipoise between the interventions given the published data regarding the consequences of anastomotic leak with and without the presence of a diverting stoma. For instance, a patient in septic shock with multiple severe medical co-morbidities would not be appropriate to randomize to a primary and unprotected anastomosis. Likely for these reasons, diverting loop ileostomy rates in the evaluated randomized control trials ranged from 66–100%. Ultimately, surgeons must balance the risk of anastomotic leak and its consequences with the morbidity of an ileostomy and second procedure for takedown on an indi­vidualized patient level.
• When performing a primary anastomosis for complicated diverticulitis, consid-
eration should be given to a diverting loop ileostomy. (Grade of recommenda-
tion: moderate; Quality of evidence: low).
Personal View
The decision to perform a Hartmann procedure vs primary anastomosis is does not neatly t into a “one size ts all” strategy. My primary considerations to operative approach include:
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How long can the patient tolerate being in the operating room?
Severe hemodynamic instability, escalating vasopressor requirement, hypothermia, acidosis, and coagulopathy are indications for damage control surgery. In these patients, the primary goal is source control and subsequent resuscitation in the intensive care unit without consideration of anastomosis. However, in patients that respond to resuscitation and require minimal use of vasopressors, anastomosis should be considered.
What is the extent of contamination?
The level of contamination within Hinchey III and IV diverticulitis can vary widely. Often, in the setting of an acute perforation, a thorough washout is adequate to pro­vide an appropriate environment from anastomosis. This can be more difcult when the perforation presents in a delayed fashion which may be associated with an abscess/phlegmon and less pliability of the otherwise healthy rectum to accept an anastomosis.
Will the patient be able to tolerate a leak? Will they tolerate an undiverted leak? Will
they be able to tolerate an ileostomy? Will medical optimization make them a
better candidate for an anastomosis in the future? Is a stoma technically
possible?
In the situation of a stable patient with a reasonably clean operative eld, the single most important question I ask myself is whether the patient can tolerate an anasto­motic leak. Several scoring systems including the sequential organ failure assess­ment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) can be utilized to estimate the risk of morbidity and mortality in the setting of sep­sis. In a patient where a leak and subsequent sepsis would be associated with very high rates of serious morbidity and mortality, I am more likely to perform a Hartmann’s procedure. This is particularly true if the patient has modiable risk factors that would signicantly lower their risk of complications if optimized. Conversely, consideration also has to be given to whether the patient will tolerate a stoma or if it is technically feasible. Patients with signicant prior small bowel resections or chronic kidney disease may suffer serious consequences from an ileos­tomy including dehydration, readmission, and worsening of their kidney disease. In these patients, consideration can be given to a diverting colostomy or a primary unprotected anastomosis. Finally, consideration has to be given as to whether a stoma can be performed at all. It is not infrequent to operate on patients with BMIs in the 50s, 60s, and 70s. In the severely obese patient, it may not be possible for an ostomy to reach the skin surface. In these patients, I am more likely to attempt a primary anastomosis, even if unprotected.
Overall, my goal is to perform a primary anastomosis whenever possible as long as the above-mentioned criteria are met. I often create a diverting loop ileostomy to mitigate the effects of a possible leak. I rarely, if ever, use a diverting colostomy due
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S. S. Hill and A. Damle
to the increased complexity of reversal as well associated reach issues with the con­duit. Typically, I will perform an on-table antegrade colonic irrigation though the enterotomy that I will subsequently use for the ileostomy. However, it is important not to get trapped into a pre-operative plan to perform a primary anastomosis if the situation is not appropriate. As in every other operation, there is no substitute for sound surgical judgement.
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36 Hartmann Procedure vs Primary Anastomosis forAcute Complicated Diverticulitis
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18. Breitenstein S, Kraus A, Hahnloser D, Decurtins M, Clavien PA, Demartines N.Emergency left colon resection for acute perforation: primary anastomosis or Hartmann's procedure? A case-matched control study. World J Surg. 2007 Nov;31(11):2117–24.
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25. Masoomi H, Stamos MJ, Carmichael JC, Nguyen B, Buchberg B, Mills S.Does primary anas­tomosis with diversion have any advantages over Hartmann's procedure in acute diverticulitis? Dig Surg. 2012;29(4):315–20.
26. Alizai PH, Schulze-Hagen M, Klink CD, et al. Primary anastomosis with a defunctioning stoma versus Hartmann's procedure for perforated diverticulitis--a comparison of stoma rever­sal rates. Int J Color Dis 2013 Dec 28(12):1681–1688.
27. Cauley CE, Patel R, Bordeianou L.Use of primary anastomosis with diverting ileostomy in patients with acute diverticulitis requiring urgent operative intervention. Dis Colon Rectum. 2018 May;61(5):586–92.
28. Lee JM, Bai PCJ, El Hechi M, etal. Hartmann's procedure vs primary anastomosis with divert­ing loop ileostomy for acute diverticulitis: Nationwide analysis of 2,729 emergency surgery patients. J Am Coll Surg. 2019 Jul;229(1):48–55.
29. Cirocchi R, Afshar S, Shaban F, etal. Perforated sigmoid diverticulitis: Hartmann's procedure or resection with primary anastomosis-a systematic review and meta-analysis of randomised control trials. Tech Coloproctol. 2018 Oct;22(10):743–53.
30. Gachabayov M, Oberkoer CE, Tuech JJ, Hahnloser D, Bergamaschi R.Resection with pri­mary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a systematic review and meta-analysis. Color Dis. 2018 Sep;20(9):753–70.
31. Ryan OK, Ryan EJ, Creavin B, Boland MR, Kelly ME, Winter DC. Systematic review and meta-analysis comparing primary resection and anastomosis versus Hartmann's procedure for the management of acute perforated diverticulitis with generalised peritonitis. Tech Coloproctol. 2020 Jun;24(6):527–43.
32. Lambrichts DP, Edomskis PP, van der Bogt RD, Kleinrensink GJ, Bemelman WA, Lange JF.Sigmoid resection with primary anastomosis versus the Hartmann's procedure for perfo­rated diverticulitis with purulent or fecal peritonitis: a systematic review and meta-analysis. Int J Color Dis. 2020 Aug;35(8):1371–86.
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