Abstract
Introduction
Previous literature related to postoperative outcomes after laparoscopic vs. open ileal pouch-anal anastomosis (IPAA) is primarily based on small numbers of patients from single institutions. The aim of this study is to evaluate these outcomes in a large number of patients using propensity score matching (PSM).
Material and Methods
The ACS-NSQIP Program data files (2016-2019) were reviewed to identify patients who underwent an IPAA creation. The impact of surgical approach on operative and postoperative outcomes were evaluated. 1:1 propensity score matching (PSM) on all patient characteristics was used to obtain matched groups. Fisher's Exact/Chi-Squared tests were used to compare outcomes between groups. A Bonferroni correction was applied to the outcomes, with a p-value of 0.0031 representing statistical significance.
Results
1802 patients were identified, with 1001 patients in the laparoscopic group and 801 patients in the open group. PSM yielded 702 patients in each matched group. Median operative time was longer for laparoscopic IPAA (278vs218.5 minutes, p<0.001). Laparoscopic IPAA patients were less likely to develop superficial and deep SSIs (3.0% vs 6.6% p=0.003). There were no differences in in-hospital mortality (0.4% vs 0.0%, p=0.3), anastomotic leak (4.0% vs 3.3%, p=1.0), organ-space SSI (6.7% vs 6.0, p=1.0), or reoperation (5.7% vs 4.0%, p=0.2) between groups. Length of stay was lower after laparoscopic IPAA (5.0 vs 6.0 days, p=0.004). There were no differences between groups in other postoperative complications.
Discussion
These data suggest that when matched for other confounding variables, laparoscopic IPAA is associated with reduced length of stay and superficial/deep SSIs when compared to open IPAA. Other surgical complications, including in-hospital mortality and anastomotic leak, are similar.
Conclusion
Given the recovery benefit of the laparoscopic approach and the reduced SSI, laparoscopy should be the method of choice for the majority of patients undergoing IPAA.
Keywords: Ileal pouch-anal anastomosis, Colorectal, IBD, Laparoscopic surgery
Introduction
Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) has become the gold standard operation performed for patients suffering from chronic/refractory ulcerative colitis and familial adenomatous polyposis (FAP). This operation offers complete resection of the involved colon and rectum with the additional benefit of restoring a continuous GI tract (usually a 2 or 3 stage process when including a de-functioning ileostomy). Great strides have been achieved since this operation was first described in 1978 [1], including the introduction of the laparoscopic approach [2] and other evolving techniques [3]. While IPAA offers excellent functional outcomes it remains a complex procedure with significant risk of morbidity [4]. To this end, determining the safest and most beneficial approach to performing this operation remains important.
Most studies on IPAA outcomes support the notion that the laparoscopic approach is effective and safe, but have yet to demonstrate any significant advantages over the open approach. A review of the results of these prior studies is listed in Table 1. Technical limitations and disappointing results from early studies have prevented the laparoscopic approach from becoming the standard of care [5]. Ongoing studies evaluating the possible benefits of the laparoscopic IPAA are necessary. This study aims to utilize the abundance of data gathered by the ACS-NSQIP proctectomy-specific program to compare surgical outcomes of open and laparoscopic IPAA creations.
Table 1.
Laparoscopic Vs. Open IPAA Review.
| Year | Author | Lap (n) | Open (n) | Single vs Multi Institution | NSQIP | Result |
|---|---|---|---|---|---|---|
| 1994 | Schmitt [6] | 22 | 20 | Single | NO | No difference in duration of ileus or length of hospitalization |
| 2000 | Marcello [7] | 20 | 20 | Single | NO | Lap group: Longer operative time (330 vs 230 min, p=<0.001), quicker ROBF (2 vs 4 d, p=0.030), shorter length of hospitalization (7 vs 8, p=0.02) |
| 2001 | Otani [8] | 10 | 18 | Single | NO | Lap group: Decreased length of hospitalization after start of eating (14.9 vs 23.8 d, p=<0.01) No data on post-op complications. |
| 2001 | Araki [9] | 21 | 11 | Single | NO | Lap group: Quicker ROBF (1.7 vs 5.4 d, p=<0.05). No difference in morbidity. |
| 2001 | Brown [10] | 12 | 13 | Single | NO | Lap group: Longer operative time (150 vs 120 min, p=<0.01). No other differences. |
| 2001 | Dunker [11] | 15 | 17 | Single | NO | No differences in functional outcomes or QOL indices. |
| 2001 | Hashimoto [12] | 11 | 13 | Single | NO | Lap group: Longer operative time (483 vs 402 min., p=<0.05), shorter length of hospitalization (24.1 vs 31.3 d, p=<0.05) |
| 2004 | Berdah [13] | 12 | 12 | Single | NO | Lap group: Longer operative time (400 vs 300 min, p=0.003), quicker ROBF (1 vs 3 d, p=0.009) |
| 2004 | Maartense [14] | 30 | 30 | Multi (2) | NO |
RCT Lap group: Longer operative time (210 vs 133 min, p=<0.001) No difference in QOL, morbidity of length of stay |
| 2005 | Larson [15] | 33 | 33 | Single | NO | No significant differences in morbidity, functional outcomes or QOL. |
| 2006 | Larson [16] | 100 | 200 | Single | NO | Lap group (including hand-assisted): Longer operative time (333 vs 230 min, p=<0.0001), quicker ROBF (through ileostomy) (2 v s 3 d, p=0.016), shorter length of stay (4 vs 4 d, <0.0001) No difference in morbidity, readmission, reoperation. |
| 2008 | Ouaïssi [17] | 23 | 22 | Single | NO | 3-stage IPAA. Lap group: Reduced cumulative length of stay (27 vs 39 d, p=<0.05). No significant difference in major complication rate (21.7 vs 40.9%, p=NS) |
| 2009 | El-Gazzaz [18] | 119 | 238 | Single | NO | Lap group: quicker ROBF (through stoma) (2d vs 3d, p=0.001), and shorter hospital stay (5 vs 6 d, p=0.001). Longer operative time (272 vs 163 min., p=0.04) |
| 2010 | Fajardo [19] | 55 | 69 | Single | NO | 2-stage IPAA. Lap group: Faster time to ileostomy closure. No differences in outcomes |
| 2011 | Fleming [20] | 339 | 337 | Multi | YES (2005-2008) |
Lap group: Reduction in major (OR = 0.67, 95% CI: 0.45-0.99, P = .04) and minor complications (OR = 0.44, 95% CI: 0.27-0.70, P = .01) **,Longer operative time (170 vs 124 min, p=≤0.0001) |
| 2013 | Schiessling [21] | 21 | 21 | Single | NO |
RCT No significant difference between groups *** |
| 2014 | Kjaer [22] | 38 | 34 | Single | NO | No significant difference in post-operative sexual function and body image |
| 2015 | Benlice [23] | 119 | 238 | Single | NO | No difference in incidence of incisional hernia and SBO (requiring hospitalization or surgery) between groups |
| 2018 | Campos [24] | 38 | 25 | Single | NO | Lap group: Longer operative time (374 vs 281 min, P=0.003), decrease in major late morbidity (2.6 vs 16%, p= <0.001) and Late Reoperation (5.2 vs 16%, p= <0.05) |
| 2018 | Mineccia [25] | 30 | 48 | Single * | NO | 3-stage IPAA. Lap group: Longer operative time (472 vs 403min, p=0.004) No differences in rate of complications |
| 2019 | McKenna [26] | 132 | 63 | Multi | YES (2012-2015) |
Pediatric Lap group: Decreased length of hospitalization (6 vs 8 d, p=<0.01), reduced odds of minor complications |
| 2019 | Colombo [27] | 100 | 150 | Multi (2) | NO | 2/3-stage IPAA. No difference in stoma complications. |
*Database from Unit of General and Oncologic Surgery, Torino, Italy. 3 surgeons.
** Reported as No. of patients with 1 or >1 major complication (Death, respiratory, cardiac, VTE, renal failure, organ space infection, sepsis, Return to OR) or minor complication (UTI or incisional infection). No significant difference for individual variables except sepsis (19 vs 37, p=0.01) and incisional infection (19 vs 4, p=.01).
*** No statistical analysis of significance was performed on the data as the trial did not reach their intended number of patients and stopped early (they no longer could recruit patients, as they all preferred the laparoscopic approach).
Material and methods
This study was approved by the Columbia University Medical Center Institutional Review Board (IRB). The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) is a database comprised of clinical data collected nationally from approximately 700 participating hospitals. Designed as an expansion of the original NSQIP program, ACS-NSQIP is an outcomes-based program that aggregates surgical information on patient demographics, medical comorbidities, laboratory values, operative details, and post-operative complications [28]. ACS-NSQIP began collecting information on colorectal specific variables in 2011-2012, with proctectomy-specific files released starting in 2016. A review of the ACS-NSQIP participant user file (PUF) merged with the proctectomy targeted PUFs was performed. Ileal Pouch Anal Anastomosis operations were identified using primary Current Procedural Terminology (CPT) codes 44157, 44158, 44211, or 45113.
Data definitions were compliant with the ACS_NSQIP Data Dictionary (available online). Variables with missing data include: height, weight, age, ASA class, total hospital length of stay (LOS), creatinine, HCT, WBC, BUN, platelets, and sodium (Appendix A). Aside from two missing ASA Class (imputed to mode), two missing total hospital LOS (imputed to median), and two ages marked 90+ that were turned to 90, all other missing data were imputed via random forest multiple imputation based on other patient characteristic (height, weight, creatinine, BUN, platelets, WBC, HCT, and sodium). Only elective cases were included in the final cohort. Surgical approach groupings were based on intent to treat (Appendix B). Complications that were present at time of operation (PATOS) were not included in the final analysis. Categories that featured some PATOS complications included superficial SSI, deep incisional SSI, organ space SSI, pneumonia, ventilation, sepsis, and septic shock (Appendix C). Additional exclusion criteria included patients who were still in-hospital, patients with an operative time less than 10 minutes (assumed data entry error), MAC/IV anesthesia, surgical specialty marked anything other than general, and patients with no wound closure. Lastly, some fields were collated due to small numbers (Appendix D).
Statistical analysis
Data were expressed as frequencies and percentages for categorical variables and compared using either the Chi-Squared test or the Fisher's Exact test depending on size (>5). Continuous variables are expressed as either mean (SD) or median (IQR) depending on normality which was tested via the Shapiro-Wilk test. They were compared with either the t-test or Wilcoxon Rank Sum, respectively.
A logistic regression with surgical approach as the dependent variable and all possible preoperative patient characteristics as the independent variables were run. These independent variables were checked for collinearity using the Variance Inflation Factor (VIF>5). No variables were deemed collinear. Next, Propensity score matching (PSM) using all variables in Table 2 was conducted using 1:1 nearest neighbor matching. A 0.2 caliper was used and a standardized mean difference of 0.1 was used to determine matching success. In order to not inflate type I error, Bonferroni correction was applied to outcomes and therefore a p-value of <0.002 is deemed significant. R statistical software (version 4.0.2, R Foundation) was used for statistical analyses.
Table 2.
Preoperative Patient Characteristics Pre- and Post-Propensity Score Match.
| Variable | Unadj. Laparoscopic(N=1001) | Unadj. Open(N=801) | SMD | Adj. Laparoscopic(N=702) | Adj. Open(N=702) | SMD |
|---|---|---|---|---|---|---|
| Age, median [IQR] | 41.0 [30.0-55.0] |
43.0 [31.0-56.0] |
0.058 | 42.0 [29.0-55.0] |
42.0 [30.0-55.0] |
0.003 |
| Male Gender, n (%) | 568 (56.7) | 461 (57.6) | 0.016 | 403 (57.4) | 402 (57.3) | 0.003 |
| Race, n (%) | 0.143 | 0.076 | ||||
| Asian | 37 (3.7) | 27 (3.4) | 25 (3.6) | 22 (3.1) | ||
| Black | 31 (3.1) | 38 (4.7) | 28 (4.0) | 27 (3.8) | ||
| Other | 125 (12.5) | 130 (16.2) | 109 (15.5) | 92 (13.1) | ||
| White | 808 (80.7) | 606 (75.7) | 540 (76.9) | 561 (79.9) | ||
| Ethnicity, n (%) | 0.134 | 0.092 | ||||
| No | 862 (86.1) | 665 (83.0) | 586 (83.5) | 608 (86.6) | ||
| Unknown | 73 (7.3) | 89 (11.1) | 67 (9.5) | 51 (7.3) | ||
| Yes | 66 (6.6) | 47 (5.9) | 49 (7.0) | 43 (6.1) | ||
| Operative Year, n (%) | 0.099 | 0.076 | ||||
| 2016 | 324 (32.4) | 265 (33.1) | 219 (31.2) | 234 (33.3) | ||
| 2017 | 355 (35.5) | 249 (31.1) | 247 (35.2) | 222 (31.6) | ||
| 2018 | 322 (32.2) | 287 (35.8) | 236 (33.6) | 246 (35.0) | ||
| BMI, median [IQR] | 25.9 [22.8-29.9] |
25.7 [22.5-29.3] |
0.062 | 25.7 [22.7-29.7] |
25.8 [22.7-29.4] |
0.011 |
| Elective, n (%) | 968 (96.7) | 761 (95.0) | 0.085 | 674 (96.0) | 680 (96.9) | 0.046 |
| Diabetes, n (%) | 54 (5.4) | 50 (6.2) | 0.036 | 41 (5.8) | 37 (5.3) | 0.025 |
| Smoking, n (%) | 101 (10.1) | 71 (8.9) | 0.042 | 73 (10.4) | 64 (9.1) | 0.043 |
| Dyspnea, n (%) | 22 (2.2) | 17 (2.1) | 0.005 | 15 (2.1) | 15 (2.1) | <0.001 |
| Functional Status, n (%) | 2 (0.2) | 5 (0.6) | 0.066 | 2 (0.3) | 0 (0.0) | 0.076 |
| COPD, n (%) | 8 (0.8) | 6 (0.7) | 0.006 | 4 (0.6) | 5 (0.7) | 0.018 |
| Ascites, n (%) | 0 (0.0) | 3 (0.4) | 0.087 | 0 (0.0) | 0 (0.0) | <0.001 |
| CHF, n (%) | 1 (0.1) | 2 (0.2) | 0.036 | 1 (0.1) | 1 (0.1) | <0.001 |
| HTN, n (%) | 160 (16.0) | 127 (15.9) | 0.004 | 111 (15.8) | 110 (15.7) | 0.004 |
| Dialysis, n (%) | 1 (0.1) | 1 (0.1) | 0.007 | 1 (0.1) | 1 (0.1) | <0.001 |
| Disseminated Cancer, n (%) | 16 (1.6) | 22 (2.7) | 0.079 | 15 (2.1) | 14 (2.0) | 0.010 |
| Wound Infection, n (%) | 5 (0.5) | 10 (1.2) | 0.081 | 5 (0.7) | 5 (0.7) | <0.001 |
| Steroid Use, n (%) | 289 (28.9) | 124 (15.5) | 0.327 | 116 (16.5) | 115 (16.4) | 0.004 |
| Weight Loss, n (%) | 42 (4.2) | 31 (3.9) | 0.017 | 24 (3.4) | 27 (3.8) | 0.023 |
| Bleeding Disorder, n (%) | 13 (1.3) | 19 (2.4) | 0.080 | 13 (1.9) | 12 (1.7) | 0.011 |
| Transfusion, n (%) | 4 (0.4) | 6 (0.7) | 0.046 | 4 (0.6) | 2 (0.3) | 0.044 |
| Sepsis, n (%) | 15 (1.5) | 13 (1.6) | 0.010 | 13 (1.9) | 8 (1.1) | 0.059 |
| Emergency, n (%) | 6 (0.6) | 13 (1.6) | 0.098 | 6 (0.9) | 1 (0.1) | 0.101 |
| Wound Class, n (%) | 0.133 | 0.064 | ||||
| 1 | 4 (0.4) | 7 (0.9) | 4 (0.6) | 2 (0.3) | ||
| 2 | 742 (74.1) | 572 (71.4) | 511 (72.8) | 514 (73.2) | ||
| 3 | 233 (23.3) | 188 (23.5) | 167 (23.8) | 171 (24.4) | ||
| 4 | 22 (2.2) | 34 (4.2) | 20 (2.8) | 15 (2.1) | ||
| ASA Class, n (%) | 0.161 | 0.048 | ||||
| 1 | 23 (2.3) | 18 (2.2) | 15 (2.1) | 17 (2.4) | ||
| 2 | 615 (61.4) | 476 (59.4) | 421 (60.0) | 433 (61.7) | ||
| 3 | 360 (36.0) | 291 (36.3) | 263 (37.5) | 250 (35.6) | ||
| 4 | 3 (0.3) | 16 (2.0) | 3 (0.4) | 2 (0.3) | ||
| Sodium, median [IQR] | 139.0 [138.0-141.0] |
139.0 [138.0-141.0] |
0.025 | 139.0 [138.0-141.0] |
139.0 [138.0-141.0] |
0.025 |
| BUN, median [IQR] | 12.0 [9.0-15.0] |
12.6 [10.0-16.0] |
0.085 | 13.0 [10.0-16.0] |
12.0 [10.0-16.0] |
0.032 |
| Creatinine, median [IQR] | 0.8 [0.7-1.0] | 0.8 [0.7-1.0] | 0.003 | 0.8 [0.7-1.0] | 0.8 [0.7-1.0] | 0.019 |
| WBC, median [IQR] | 7.3 [5.8-9.1] | 6.9 [5.6-8.6] | 0.134 | 7.0 [5.7-8.7] | 6.9 [5.7-8.7] |
0.021 |
| HCT, median [IQR] | 40.0 [36.1-43.0] |
40.0 [37.0-43.1] |
0.057 | 40.2 [36.7-43.3] |
40.0 [37.0-43.1] |
0.010 |
| Platelets, median [IQR] | 288.0 [233.0-365.0] |
271.0 [220.0-330.0] |
0.211 | 275.0 [224.0-336.5] |
274.5 [226.0-333.0] |
0.024 |
Unadj=unadjusted; Adj=adjusted; SMD=standardized mean difference; BUN= Blood Urea Nitrogen; WBC=white blood count; HCT=hematocrit
Theory
An analysis of ACS-NSQIP data collected during 2005-2008, comparing open and laparoscopic IPAA with a diverting ileostomy, reported a reduced rate of both major and minor complications during the 30-day post-operative period with the laparoscopic approach [20]. The ACS-NSQIP began to collect information regarding colorectal-specific variables in 2012. There has been only one study that we identified, and in the pediatric population, utilizing these data to study the impact of surgical approach on IPAA outcomes. When comparing laparoscopic vs. open TPC-IPAA in the pediatric population, the laparoscopic approach was associated with a decrease in minor complications such as superficial surgical site infection and urinary tract infection and length of stay [26].
A meta-analysis of 11 studies comparing open and laparoscopic proctocolectomy with IPAA revealed no significant difference in clinical outcomes between the two groups [29]. That meta-analysis included the only complete randomized control trial ever performed, comparing laparoscopic hand-assisted and open proctocolectomy with IPAA. That study also reported similar recovery patterns between the two approaches using verified quality of life indices [30]. As most patients prefer laparoscopic surgery when given a choice, prospective studies comparing the open and laparoscopic approaches may be challenging to perform. Utilizing the available retrospective data is therefore essential in further delineating whether there are distinct clinical benefits of the laparoscopic approach for this complex operation.
Results
Demographic and clinical data
A total of 1802 patients who underwent proctocolectomy with IPAA were identified and included in the analysis. In the unadjusted cohort, there were 1001 patients in the laparoscopic group (55.5%) and 801 (44.5%) in the open group. In the unadjusted cohort, the median age was 41 years for the laparoscopic group and 43 years for the open group. The majority of patients in both the laparoscopic and open groups were male (56.7% and 57.6%, respectively) and white (80.7% and 75.7%). Median BMI among both groups were at the upper limit of normal. The preoperative medical history and laboratory work of patients in both groups were generally equivalent. More patients in the laparoscopic groups were listed as using steroids chronically (28.9% vs 15.5%). Using 32 variables, PSM matching was successful (all SMD <0.1) with 702 patients in each matched group. All demographic information and clinical characteristics of the patient groups are listed in Table 2, both pre and post-PSM.
Adjusted surgical outcomes
Thirty-day post-operative complications, with pre and post- PSM adjustment values, are listed in Table 3. Following PSM and using Bonferroni Correction, there was a decrease in the incidence of superficial and deep surgical site infections between the laparoscopic and open groups (3.0% vs 6.6%, p=0.003). Laparoscopic cases were longer than open cases (278 min. IQR [217.0-359.8] vs. 218.5 min. IQR [165.0-296.0], p<0.001). Length of stay was shorter in the laparoscopic group (5 d. vs 6 d, p=0.004), although it did not reach statistical significance by Bonferonni correction. Similarly, with the Bonferroni correction there was no difference in the incidence of reintubation or prolonged ventilation between laparoscopy and open groups but it is worth noting (1% vs 0%, p=0.02).
Table 3.
Outcomes Pre- and Post-Propensity Score Match.
| Variable | Unadj. Laparoscopic(N=1001) | Unadj. Open(N=801) | p-value | Adj. Laparoscopic(N=702) | Adj. Open(N=702) | p-value |
|---|---|---|---|---|---|---|
| Operative Time, median [IQR] | 285.0 [222.0-369.0] |
220.0 [165.0-296.0] |
<0.001 | 278.0 [217.0-359.8] |
218.5 [165.0-296.0] |
<0.001* |
| Total Hospital LOS, median [IQR] | 5.0 [4.0-8.0] | 6.0 [4.0-8.0] | <0.001 | 5.0 [4.0-8.0] | 6.0 [4.0-8.0] | 0.004 |
| Anastomotic Leak, n (%) | 40 (4.0) | 32 (4.0) | 1.0 | 28 (4.0) | 23 (3.3) | 0.6 |
| In-hospital Mortality, n (%) | 3 (0.3) | 2 (0.2) | 1.0 | 3 (0.4) | 0 (0.0) | 0.3 |
| Superficial/Deep Infection, n (%) | 29 (2.9) | 60 (7.5) | <0.001 | 21 (3.0) | 46 (6.6) | 0.003* |
| Organ Space SSI, n (%) | 76 (7.6) | 57 (7.1) | 1.0 | 47 (6.7) | 46 (6.6) | 1.0 |
| Dehiscence, n (%) | 2 (0.2) | 3 (0.4) | 1.0 | 1 (0.1) | 2 (0.3) | 1.0 |
| Pneumonia, n (%) | 14 (1.4) | 7 (0.9) | 0.4 | 8 (1.1) | 2 (0.3) | 0.1 |
| Reintubation/Prolonged Ventilation, n (%) | 8 (0.8) | 1 (0.1) | 0.5 | 7 (1.0) | 0 (0.0) | 0.02 |
| Pulmonary Embolism/DVT, n (%) | 25 (2.5) | 15 (1.9) | 0.5 | 14 (2.0) | 12 (1.7) | 0.8 |
| Renal Insufficiency/Failure, n (%) | 18 (1.8) | 14 (1.7) | 1 | 15 (2.1) | 11 (1.6) | 0.6 |
| Stroke/CVA, n (%) | 1 (0.1) | 0 (0.0) | 1 | 1 (0.1) | 0 (0.0) | 1 |
| Cardiac Arrest/MI, n (%) | 3 (0.3) | 2 (0.2) | 1 | 3 (0.4) | 1 (0.1) | 0.6 |
| Bleed Requiring Transfusion, n (%) | 56 (5.6) | 58 (7.2) | 0.2 | 40 (5.7) | 44 (6.3) | 0.7 |
| Sepsis/Septic Shock, n (%) | 36 (3.6) | 32 (4.0) | 1.0 | 27 (3.8) | 24 (3.4) | 0.8 |
| Reoperation, n (%) | 58 (5.8) | 36 (4.5) | 0.3 | 40 (5.7) | 28 (4.0) | 0.2 |
Unadj=unadjusted; Adj=adjusted; SMD=standardized mean difference; LOS=length of stay; SSI=surgical site infection; DVT=deep vein thrombosis; CVA=cerebrovascular accident; MI=myocardial infarction
*Bonferroni Correction Deems Significant
There was no difference in anastomotic leak, organ space surgical site infection, or septic complications between the two surgical approaches. Laparoscopic IPAA was not associated with an increase in thirty-day reoperation or mortality as compared to open.
Discussion
Ileal Pouch-Anal Anastomosis remains the gold standard for patients undergoing proctocolectomy for ulcerative colitis and FAP. However, there still lacks any significant evidence of the benefits of laparoscopy for IPAA. While even the earliest studies demonstrated the safety and feasibility of the laparoscopic approach [[6], [31], [32]], few studies since have demonstrated significant benefits over the open approach. In addition, most studies comparing the two surgical approaches are single-institution with small patient sample sizes (Table 1). The largest study to date, from the Cleveland Clinic, reported no difference in thirty-day or long-term outcomes between groups, aside from shorter hospital stay. There also was no significant difference in reported quality of life or functional outcomes between groups at 1 and 5 year follow-ups [18].
There have only been two randomized controlled trials performed comparing laparoscopic and open IPAA. The first compared 30 patients in each group (hand-assisted laparoscopic vs open), with no difference in morbidity or mortality between groups demonstrated [28]. The second trial of its kind, the LapConpouch Trial, was prematurely stopped due to problems with patient recruitment. Interestingly, overwhelming patient preference for the laparoscopic approach was the cause of recruitment failure [21].
Our study utilizes the large ACS-NSQIP database and proctectomy-specific outcomes data to compare the laparoscopic and open IPAA. This represents the largest of its kind, with a total of 702 PSM-matched pairs. There was no difference in thirty-day post-operative morbidity or mortality when compared to the open approach, again reaffirming its safety. The laparoscopic approach had the advantage of being associated with a reduced incidence of superficial and deep surgical site infections. Operative time was significantly longer in the laparoscopic group, as is expected and consistent with previous studies. Similar to previous studies, there was a shorter LOS for patients undergoing laparoscopic IPAA.
The validated data from ACS-NSQIP allows for study of a large sample size, and is somewhat representative of multiple institutions across the country. The proctectomy-specific data, first collected starting in 2016, allows for inclusion of some important colorectal-specific post-operative complications, such as anastomotic leak. It should be noted that information on the presence or absence of ileus for our subset of patients was not available. In addition, this study does not include other IPAA cases in the ACS-NSQIP database from prior to the year 2016, as it could not be merged with the proctectomy-specific ACS-NSQIP files. Limitations of the ACS-NSQIP database include the absence of data regarding surgeon-experience and institution-specific factors that may impact results. This dataset also does not distinguish between 2 vs. 3 stage IPAA procedures and does not report on use of mechanical bowel prep, preoperative antibiotics, and skin preparation protocols. Additional studies focusing on the long-term results of laparoscopic IPAA remain necessary, as well as true randomized-controlled trials.
Conclusions
In conclusion, laparoscopic IPAA creation is shown to be safe without additional risk of morbidity/mortality as compared to the open approach with the retrospective review of the NSQIP database. It is also associated with decreased risk of superficial and deep surgical site infections. Laparoscopy should be a preferentially considered surgical approach for patients undergoing IPAA creation.
Author contributions
All authors made substantial contributions to this manuscript, including the study conception, data collection, analysis of results, and manuscript preparation. All authors reviewed the results and approved the final version of the manuscript.
Funding/financial support statement
There are no financial conflicts of interest to disclose. There are no further sources of financial support to acknowledge.
Ethics approval
This work has been approved by the appropriate ethical committee at our institution.
Conflict of Interest Statement
The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Footnotes
Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.sipas.2022.100114.
Contributor Information
Koby Herman, Email: kah2260@cumc.columbia.edu.
Ravi P. Kiran, Email: rpk2118@cumc.columbia.edu.
Appendices
Appendix A.
Missing Data of the final N=1802 cohort.
| Variable | N(%) | How dealt with |
|---|---|---|
| Height | 12 (0.67%) | Random Forest Multiple Imputation |
| Weight | 10 (0.55%) | Random Forest Multiple Imputation |
| Age 90+ | 2 (0.11%) | Turned to 90 |
| ASA Class | 3 (0.17%) | Imputed to the mode |
| Total Hospital LOS | 2 (0.11%) | Imputed to the median |
| Creatinine | 231 (12.82%) | Random Forest Multiple Imputation |
| WBC | 177 (9.82%) | Random Forest Multiple Imputation |
| HCT | 162 (8.99%) | Random Forest Multiple Imputation |
| BUN | 310 (17.20%) | Random Forest Multiple Imputation |
| Platelets | 176 (9.77%) | Random Forest Multiple Imputation |
| Sodium | 243 (13.49%) | Random Forest Multiple Imputation |
Appendix B.
Surgical Approaches Included.
| Laparoscopic | Laparoscopic with open assist, Laparoscopic with unplanned conversion to open, Robotic, Robotic with open assist, SILS, SILS with open assist, SILS with unplanned conversion to open, Robotic with unplanned conversion to open |
| Open | Open (planned) |
Appendix C.
Exclusions.
| Variable | N | How dealt with |
|---|---|---|
| Superficial SSI PATOS | 3 | Excluded from Analysis |
| Deep Incisional SSI PATOS | 1 | Excluded from Analysis |
| Organ Space SSI PATOS | 13 | Excluded from Analysis |
| Pneumonia PATOS | 0 | Excluded from Analysis |
| Ventilation PATOS | 0 | Excluded from Analysis |
| Sepsis PATOS | 6 | Excluded from Analysis |
| Septic Shock PATOS | 0 | Excluded from Analysis |
| Wound Closure (Not closed) | 1 | Excluded from Analysis |
| Still In-hospital | 19 | Excluded from Analysis |
| Operative Time < 10 min | 2 | Excluded from Analysis |
| MAC/IV Anesthesia | 1 | Excluded from Analysis |
| Non-general surgery specialty | 3 | Excluded from Analysis |
*a patient may have more than one exclusion so counts do not add up to the total number of patients excluded
Appendix D.
Data Collation of the final N=1802 cohort.
| Variable | N | How Collated |
|---|---|---|
| American Indian | 7 | Collated with Race Other |
| Pacific Islander | 3 | |
| Insulin Diabetes | 43 | Collated to be Diabetes Yes |
| Non-insulin Diabetes | 61 | |
| Dyspnea At Rest | 2 | Collated to be Dyspnea Yes |
| Dyspnea On Moderate Exertion | 37 | |
| Partial Dependent Functional Status | 6 | Collated to be Functional Status Dependent |
| Totally Dependent Functional Status | 1 | |
| Sepsis | 3 | Collated to be Yes in Preop Sepsis field |
| Septic Shock | 0 | |
| SIRS | 25 |
Appendix B. Supplementary materials
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