Is primary anastomosis a safe procedure? Comparison between primary anastomosis without diverting stoma and Hartmann’s procedure for colorectal perforation: A single- center, retrospective study

doi:10.21203/rs.3.rs-1525320/v1

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Is primary anastomosis a safe procedure? Comparison between primary anastomosis without diverting stoma and Hartmann’s procedure for colorectal perforation: A single- center, retrospective study

https://doi.org/10.21203/rs.3.rs-1525320/v1

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Background

Hartmann’s procedure (HP) has been performed for colorectal perforation to avoid the risk of anastomotic leakage. Few reports have compared the safety between primary anastomosis without diverting stoma (PAWODS) and HP for colorectal perforation, and whether PAWODS or HP should be performed has remained controversial. We aimed to investigate the feasibility and safety of performing PAWODS in comparison to HP for colorectal perforation.

Methods

We retrospectively collected the data of 97 consecutive patients with colorectal perforation who underwent surgery from April 2010 to December 2020. PAWODS and HP were performed in 51 and 46 patients, respectively. Univariate and multivariate analyses were performed to compare the clinical characteristics and postoperative outcomes of patients treated with PAWODS with those treated with HP .

Results

In the multivariate analysis, low serum albumin (hazard ratio [HR]=3.49 [95%CI=1.247-9.757] P=0.017) and left-sided colon and rectum perforation (HR=16.8 [95%CI=1.792-157.599] P=0.014) were significantly associated with the decision to perform HP. There was significant difference in the mortality of the two groups (PAWODS vs. HP: 0% vs. 8.7%; P=0.047). The severe morbidity rate (Clavien-Dindo III-V) was significantly higher in the HP group (PAWODS vs. HP: 10% vs. 30%; P=0.020). In the PAWODS group, anastomotic leakage occurred in 5 of 51 patients (9.8%), 4 (8.7%) of whom required re-operation.

Conclusions

In appropriately selected patients, PAWODS could be safely performed with an acceptable rate of anastomotic leakage. The serum albumin level and site of perforation may be simple and useful factors for guiding decision-making on the surgical procedure.

colorectal perforation

Hartmann’s procedure

primary anastomosis

diverting stoma

Colorectal perforation is a serious disease that requires emergency surgery. Hartmann's procedure (HP) has been considered to be the most common procedure for avoiding the risk of anastomotic leakage (1,2). However, recently, several randomized controlled trials (RCTs) have shown that primary anastomosis was superior to Hartmann’s procedure with regard to the stoma reversal rate and 12-month stoma-free survival with no significant differences in postoperative morbidity or mortality, even in cases involving perforated diverticulitis with purulent or fecal peritonitis classified as Hinchey III-IV (3–6). In these RCTs, however, diverting stoma was constructed in most cases in the primary anastomosis group, and the factors that can be used to identify patients who potentially do not require diverting stoma are not fully understood (3–5). For cases in which a diverting stoma is constructed, the operation time is extended and stoma complications (e.g., stoma stenosis or parastomal hernia) may occur (7). Therefore, primary anastomosis without diverting stoma (PAWODS) is a more favorable surgical procedure if it is safely performed, but there have been no RCTs comparing the safety of PAWODS and HP. There are only three retrospective studies comparing the safety of PAWODS and HP for colorectal perforation (7–9). In clinical settings, the decision as to whether to perform PAWODS or HP is decided during the operation by surgeons; however, the appropriate indications for PAWODS are not fully understood. In this study, to clarify the indications for cases in which PAWODS can be performed safely, we retrospectively investigated factors used to decide surgical procedures, and the short-term outcomes of PAWODS.

Study design and patients

This present single-center, retrospective study included 122 consecutive patients who underwent surgery for colorectal perforation in Toyonaka Municipal Hospital between April 2010 and December 2020. After excluding 25 patients (anastomotic leakage, n = 13; construction of ileostomy or loop colostomy, n = 5; primary anastomosis with diverting stoma, n = 1; and only drainage or primary suture, n = 6), 97 patients who received PAWODS (n = 51) or HP (n = 46) were analyzed (Fig. 1).

In all cases, the preoperative diagnosis of colorectal perforation was based on CT findings. Perforation was definitively diagnosed by pathological findings or by macroscopically apparent perforation in all cases. The surgical procedures were not randomized, but were determined in individual cases by experienced gastroenterological surgeons. In all cases, patients were entered into the intensive care unit (ICU) after surgery, and blood tests were performed before surgery and just after entering the ICU.

Data collection

Medical records were retrospectively reviewed, and patient information, including sex, age, body mass index (BMI), and American Society of Anesthesiologist physical status classification (ASA-PS), was collected. We also recorded perioperative outcomes, including the operation time, site of perforation, cause of perforation, severity of intra-abdominal pathology, and postoperative complications. We defined the cecum to the transverse colon as the right-sided, and the descending colon to the rectum as the left-sided. We calculated acute physiological and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores to evaluate the severity of sepsis (10,11). The APACHE II score was calculated preoperatively, and the SOFA score was calculated intraoperatively with reference to anesthesia records. The severity of intra-abdominal pathology was intraoperatively graded using the Hinchey classification (I, II were localized, III was purulent, and IV was fecal peritonitis) (6). Postoperative complications were graded using the Clavien-Dindo Classification (CDC), with CDC grades of III-V defined as severe (12).

Statistical analysis

All statistical analyses were performed using the JMP Pro 15 software program (SAS Institute, Cary, NC, UAS). In the univariate analysis, categorical variables were compared using Fisher’s exact test. Continuous data are reported as the median and interquartile range. Comparisons of continuous variables were examined using the Wilcoxon rank test. P values of < 0.05 were considered statistically significant, and factors with a P value of < 0.05 in the univariate analysis were entered into the multivariate analysis.

Patient characteristics

Table 1 shows all of the patient characteristics. The median [interquartile range] age was 72 [61–82] years, 32% of patients had an ASA-PS score of III or worse, and the median serum albumin level was 3.1 [2.5–3.7] mg/dL. The median [interquartile range] APACHE II and SOFA scores were 7 [5–11] and 4 [1–5]. There were 17 (18%) patients with right-sided perforation and 80 (82%) with left-sided perforation. Thirty-two (33%) had a Hinchey Classification of III and 26 (27%) had a Hinchey Classification of IV. Laparoscopic surgery was performed in 28 patients (29%).

Predictive factors for primary anastomosis without diverting stoma

The factors associated with the performance of HP in the univariate analysis of the PAWODS and HP groups are shown in Table 2. Age (PAWODS vs. HP: 67 [55–78] years vs. 79 [69–85] ; P < 0.001), APACHE II score (6 [3–8] vs. 9.5 [7–13] ; P < 0.001) and SOFA score (2.5 [1–4] vs. 4 [3–6]; P < 0.001) were significantly higher in the HP group than in the PAWODS group. The percentage of male patients (PAWODS vs. HP: 61% [n = 31] vs. 39% [n = 18]; P = 0.044) and serum albumin level (PAWODS vs. HP: 3.4 [2.8–3.8] mg/dL vs. 2.7 [2.2–3.2] ; P < 0.001) were significantly lower in the HP group than in the PAWODS group. The rate of left-sided perforation (PAWODS vs. HP: 69% [n = 35] vs. 98% [n = 45]; P < 0.001) was significantly higher in the HP group than in the PAWODS group. In the multivariate analysis, a serum albumin level of ≤ 3.1 mg/dL (hazard ratio [HR] = 3.49 [95%CI = 1.247–9.757] P = 0.017) and left-sided perforation (HR = 16.8 [95%CI = 1.792-157.599] P = 0.014) were identified as independent predictive factors for the performance of HP (Table 3).

Morbidity and mortality

The rates of postoperative morbidity and mortality are shown in Table 4. The overall morbidity rate of the PAWODS and HP groups did not differ to a statistically significant extent (PAWODS vs. HP: 53% vs. 54%; P = 1.000); however, the severe morbidity rate was of the PAWODS group was significantly lower than that of the HP group (PAWODS vs. HP: 10% vs. 30%; P = 0.020). The organ space surgical site infection (SSI) rate in the PAWODS group was significantly lower than that in the HP group in overall population (3.9% vs. 22%; P = 0.012) and in the patients with a severe CDC grade (0% vs. 15%; P = 0.004). Five of 51 patients (9.8%) in the PAWODS group developed anastomotic leakage, 4 of whom (8.7%) required re-operation. No death occurred in the PAWODS group, while 4 deaths (8.7%) occurred in the HP group (P = 0.047); the causes of death were sepsis leading to multiple organ failure (n = 3) and venous thromboembolism (n = 1). The median length of the hospital stay was significantly shorter in the PAWODS group in the HP group (PAWODS vs. HP: 13 [10–22] days vs. 23 [17–39]; P = 0.020).

Risk factors for anastomotic leakage

The risk factors for anastomotic leakage in the PAWODS group are shown in Table 5. Anastomotic leakage did not occur in patients with right-sided perforation, but we found no significant differences in the sites of perforation between the PAWODS and HP groups (P = 0.155). The rate of anastomotic leakage in patients treated with the double stapling technique (DST) tended to be higher than that of patients who received functional end-to-end anastomosis (FEEA); however, the difference was not statistically significant (P = 0.354).

In the present study, firstly, we evaluated the factors that impacted on the surgeon’s decision of surgical procedure. In the univariate analysis, age, sex, serum albumin level, APACHE II score, SOFA score, and the site of perforation were identified as predictive factors for deciding surgical procedure. In the multivariate analysis, the serum albumin level and the site of perforation were remained as independent predictive factors for deciding the surgical procedure. The serum albumin level reflects the preoperative nutritional status and general condition (13,14). A low serum albumin level is a risk factor for anastomotic leakage and is a risk factor for mortality during sepsis due to vascular hyperpermeability (15–19). In our study, the serum albumin level of the HP group was significantly lower than that of the PAWODS group, which means that surgeons had appropriately selected HP for patients with poor conditions. This result was similar to previous studies; the HP group was significantly older, more hemodynamically unstable, and more immunosuppressive than the PAWODS group (8,9). Also, APACHE II and SOFA scores are other indicators of the general condition that are useful for predicting the severity and prognosis of sepsis (10,11). Although we speculated that the APACHE II and SOFA scores could be associated with decision-making in relation to the surgical procedures, these factors were not associated with the surgical procedures in the present study. Furthermore, regarding the simplicity of calculation, the serum albumin level is much simpler to determine in comparison to the than APACHE II and SOFA scores, which require complicated calculations. The serum albumin level was a simple predictive factor that was useful for deciding the surgical procedure in the present study cohort.

Considering the postoperative results in the present study, the HP group had significantly higher mortality and morbidity rates than the PAWODS group. Zingg et al. reported that in the HP group, the mortality and morbidity rates were significantly higher and that the baseline characteristics were significantly worse in comparison to the PAWODS group (8). On the other hand, Tsuchiya et al. revealed that the 30-day mortality and re-operation rates were significantly higher in the PAWODS group than in the HP group; however, in that study, the baseline characteristics were adjusted using propensity score matching (7). Thus, although it may be risky to perform PAWODS for all patients with colorectal perforation, it may be safely performed with equivalent mortality and morbidity rates to HP in appropriately selected patients. In the present study, the favorable postoperative outcomes of PAWODS also supported that the intraoperative decision regarding the choice of surgical procedure was appropriate.

In the present study, the incidence rate of anastomotic leakage was 9.8% (5/51) and 7.8% (4/51) of patients required re-operation. These rates of anastomotic leakage were similar to the incidence rates of 4–14% that were reported in patients who underwent primary anastomosis with or without diverting stoma for perforated diverticulitis (3,4,20–22). However, in these studies, most patients received primary anastomosis with diverting stoma, a diverting stoma in 50–100% of cases (3,4,21). The rate of anastomotic leakage in patients who received PAWODS for perforated diverticulitis has only been reported in one study and the rate of anastomotic leakage of any grade was 28.3% (8). Therefore, we thought that the anastomotic leakage rate of 9.8% in the present study was acceptable. This acceptable anastomotic leakage rate may also imply that we could appropriately assign patients to PAWODS and HP groups intraoperatively.

We investigated the risk factors for anastomotic leakage in patients treated with PAWODS. In the present study, no anastomotic leakage occurred in patients with right-sided colon perforation and only patient treated with FEEA developed anastomotic leakage. Although the right-side location and FEEA tended to be associated with less anastomotic leakage in comparison to left-side location and DST, we could not find significant differences between these groups. We thought that the location and procedure of anastomosis were strong candidate factors; however, we speculated that significant differences were not found due to the weak statistical power of the present study as a result of its relatively small population. Notably, in this study, 16 patients (94%) with right-sided colon perforation received PAWODS and none of these patients developed anastomotic leakage. A previous study of right-sided colon perforation also reported that none of 34 patients with right hemicolectomy developed anastomotic leakage (23). Although serum albumin level is known to be associated with anastomotic leakage, we found no significant association in our study (15). As described above, the serum albumin levels in HP patients were significantly lower than those in PAWODS patients. Therefore, after the exclusion of HP patients with relatively lower serum albumin levels, the serum albumin level may not have remained as an independent risk factor for anastomotic leakage among patients with serum albumin levels above a certain level. In the appropriately selected patients, PAWODS may be a safe surgical procedure that is associated with an acceptable rate of anastomotic leakage. Especially, we thought that PAWODS could be safely performed for patients with right-sided colon perforation.

The present study was associated with some limitations. First, this was a single-center, retrospective observational study with a relatively small population; thus, selection biases may have existed and the results might have been affected by the retrospective design. Second, we included right-sided colon perforation. There are only two retrospective studies of right-sided colon perforation (23,24). However, the results obtained after the exclusion of right-sided cases did not differ from the results of analyses that included the right-sided cases (data not shown). In our study, the rate of anastomotic leakage in patients with left-sided perforation was 14%, and this may also be acceptable in comparison to previous studies (8). Third, thirty-nine patients (40%) had localized peritonitis classified as Hinchey I-II, and this rate was relatively high in comparison to previous studies (3–5,25).

Our study indicated that in the appropriately selected patients, we could safely perform PAWODS for colorectal perforation. The preoperative serum albumin level and location of perforation is a simple and useful factor for guiding decision-making on the surgical procedure.

HP, Hartmann’s procedure; PAWODS, primary anastomosis without diverting stoma; HR, hazard ratio; RCT, randomized controlled trials; ICU, intensive care unit; BMI, body mass index; ASA-PS, American Society of Anesthesiologist physical status classification; APACHE, acute physiological and chronic health evaluation; SOFA, sequential organ failure assessment; CDC, Clavien-Dindo Classification; SSI, surgical site infection; DST, double stapling technique; FEEA, functional end-to-end anastomosis

Ethics approval and consent to participate

This study was approved by the Institutional Review Board of Toyonaka Municipal Hospital (Approval number: 2021-07-02), which waived the need for informed consent. This study was performed in accordance with the Declaration of Helsinki.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

No funding was received for this study.

Author’s contributions

RO and HT contributed to the conception, the design, the acquisition, analysis interpretation of date, drafting and revising of the work. SN, YS, KO, YY, MY, JS, HI, TI, NT, and KD contributed to the acquisition, analysis of data, and drafting or revising the work. All authors approved the final manuscript.

Acknowledgements

Not applicable

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Tables 1 to 5 are available in the Supplementary Files section

No competing interests reported.

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Is primary anastomosis a safe procedure? Comparison between primary anastomosis without diverting stoma and Hartmann’s procedure for colorectal perforation: A single- center, retrospective study

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