The same rate of parastomal hernia reparations in the different approaches to colostomy

doi:10.21203/rs.3.rs-2440186/v1

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The same rate of parastomal hernia reparations in the different approaches to colostomy

https://doi.org/10.21203/rs.3.rs-2440186/v1

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Backgrounds

Parastomal hernias are common with permanent colostomies and result in complications. This study aimed to compare the rate of parastomal hernia reparations in the different approaches to colostomy after abdominoperineal resection for rectal cancer and to further investigate the risk factors for parastomal hernia formation in patients with permanent colostomies.

Methods

Consecutive rectal cancer patients who underwent abdominoperineal resection from June 2014 to July 2020 in West China Hospital were divided into the extraperitoneal group and transperitoneal group according to their surgical approach for permanent colostomies. The impact of different approaches to colostomy on parastomal hernia reparations was determined by comparing a group of patients receiving an extraperitoneal route to colostomy with a group receiving transperitoneal. Potential variables were evaluated first with univariate and then multivariate analyses to identify the risk factors for the formation of parastomal hernia.

Results

In total, 202 subjects in the transperitoneal group and 103 in the extraperitoneal group attended the follow-up visit with a median follow-up period of 33 (25th–75th percentiles, 17–46) months. Clinically and radiologically detectable parastomal hernias were present in 76 of 202 (37.6%) and 14 of 103 (13.6%) subjects in the transperitoneal and extraperitoneal groups during the follow-up period (p<0.01). Besides, 10 of 76 (13.1%) subjects in the transperitoneal group and 2 of 14 (14.3%) subjects in the extraperitoneal group underwent a parastomal hernia operation during the follow-up (p = 0.82). In addition, the transperitoneal approach of colostomy (p = 0.002), older age (p<0.001), and higher BMI (p = 0.013) were identified as independent risk factors for the occurrence of parastomal hernia.

Conclusions

Extraperitoneal colostomy decreased the rate of detectable parastomal hernias but didn’t reduce the rate of surgical reparation of parastomal hernias.

Parastomal hernia

Extraperitoneal colostomy

Transperitoneal colostomy

Abdominoperineal resection

Abdominoperineal resection (APR) has been introduced as a standard radical surgical approach for patients with ultralow rectal cancers not indicated for anal sphincter preservation.^[1] However, the favorable oncological outcomes of APR are at the cost of permanent sigmoidostomy, which may bring serval dilemmas and reduce the quality of life (QOL) for patients who undergo APR. Parastomal hernia (PSH) is one of the common complications after permanent sigmoidostomy, with a reported incidence ranging from 4–48%.^[2] The occurrence of PSH may bring some intolerable symptoms, such as anastomotic stenosis and anastomotic prolapse, and even lead to large bowel obstruction, which may require surgical treatment.^{[3, 4]}

Attempting to prevent PSH has long been made. Satisfactory results for PSH prevention using meshes have been reported since the 1990s.^[5–9] However, concerns that meshes may bring additional costs^[10] without desired results have been raised. According to Cross et al.,^{[8, 11, 12]} inappropriate use of meshes may increase the risk of infection and fistula. Christoffer et al. ^{[13, 14]} conducted a randomized controlled trial and found that prophylactic mesh repair could not reduce the incidence of parastomal hernia. Serra-Aracil et al. ^[12] reported after a mean follow-up of 29 months, 6 of 27 patients who underwent permanent sigmoidostomy and received a lightweight mesh prevention approach developed PSH.

The extraperitoneal route to colostomy, introduced by Goligher in 1958, is one of the classical methods of colostomy. To date, there is still no consensus on the utility of permanent sigmoidostomy in the prevention of PSH. The European Hernia Association argues that there is insufficient evidence supporting that extraperitoneal colostomy has an advantage in reducing the incidence of PSH compared with the transperitoneal colostomy.^[15] However, some meta-analyses have indicated that the technique of extraperitoneal colostomy significantly lowers the incidence of PSH.^{[16, 17]}

In our center, both extraperitoneal and transperitoneal approaches in colostomy are used. The current study aimed to evaluate the efficiency of both colostomy approaches, compare the rate of parastomal hernia reparations in the different approaches to colostomy after abdominoperineal resection for rectal cancer, and to further investigate the risk factors for parastomal hernia formation in patients with permanent colostomies.

Patients and study design:

From June 2014 to July 2020, consecutive rectal cancer patients who underwent APR in the Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, were divided into the extraperitoneal group and a transperitoneal group. All patients are operated by six experienced surgeons in the department, and the method of colostomy is determined according to the treatment experience of each doctor.

The inclusion criteria were as follows: histologically-proven rectal cancer; curative resection; abdominoperineal resection with permanent colostomy; Patients with non-curative resection or temporary colostomy or previous abdomen operation history or emergency operation were excluded.

This study was approved by the institutional review board of West China Hospital, Sichuan University. The study was registered at the Chinese Clinical Trial Registry (Identifier: ChiCTR2200056134).

Surgical Technique

All eligible patients underwent APR performed by six experienced surgical teams focused on colorectal cancers in West China Hospital. After taking out the specimen of rectal cancer, colostomies were performed.

For the extraperitoneal route, the peritoneum along the left paracolic gutter was separated from the abdominal wall to make an internal opening for the extraperitoneal tunnel before the skin incision. Then, a circular incision of approximately 25 mm in diameter was made at the marked site. The skin was removed, and subcutaneous tissues were incised. Next, the anterior rectus sheath was opened with a cross incision, and the rectus abdominis was gently split to expose the posterior rectus sheath. Then, the posterior rectus sheath was dissected with care to not open the peritoneum. The peritoneum was gently separated from the abdominal wall, and this space was then connected to the previously dissected space along the left paracolic gutter to create an extraperitoneal tunnel. The stump of the colon was exteriorized through this tunnel. After exteriorization, the bowel wall was fixed to the anterior rectus sheath at four points using absorbable monofilament sutures. Finally, the stump of the colon was opened and sutured to the skin before the end of the operation.

For the transperitoneal route, both the posterior rectal sheath and the peritoneum were cut longitudinally, and the diameter of the tunnel was dilated to two finger widths. The stump of the colon was exteriorized through the tunnel.

Data Collection

Demographic and perioperative data including age, sex, body mass index (BMI), ASA classification of anesthesia, neoadjuvant therapies, surgical approaches, and comorbidities were retrospectively collected from the electronic clinical records.

In our center, postoperative follow-ups (including CT reviews) were settled at 1 month and 3 months after APR, every 6 months in the first 5 years and every year after 5 years according to routine follow-up protocol for rectal cancer.^[18]

Follow-up information was obtained from medical records, outpatient clinic visits and phone calls.

The endpoint included the occurrence of PSH, but mainly the repair rate of parastomal hernia with different approaches. In our study, The definition of parastomal hernia adopts European Hernia Society(ESH) standard (PSH is an abnormal protrusion of the contents of the abdominal cavity through the abdominal wall defect created during placement of a colostomy), and the classification method of parastomal hernia through CT scan proposed by ESH.^[19] Postoperative surveillance CT scans were separately reviewed by two radiologist (Lu Zhang and Yan Yu). When a discrepancy arose, the CT scans were reviewed by an experienced radiologist (Hanjiang. Zeng) to reach a consensus (Fig. 2). In addition, when the CT scan is negative but the clinical symptoms are positive, it is also determined to be a PSH.

The secondary endpoints were the occurrence of intra- and post-operative complications including peristomal infection, stoma bleeding, mucocutaneous separation, anastomotic stenosis, anastomotic prolapse, adhesive intestinal obstruction, and incision or pelvic infection.

Statistical analysis:

SPSS for Windows, version 22.0 (IBM Corp, Armonk, NY) and GraphPad Prism for Windows, version 8.0.0 (GraphPad Software, San Diego, California) were used for data analysis. Continuous data are shown as the mean and standard deviation. Categorical variables are represented as percentages. Continuous variables were compared by using parametric or non-parametric. Categorical variables were compared between groups using Fisher’s exact test or the chi-square test. Kaplan–Meier curves of the likelihoods of the occurrence of PSH were analyzed using the log-rank test. Variables related to the occurrence of PSH were first analyzed with univariate analysis. Potential risk factors (p < 0.05) were then entered into a multivariable model using stepwise logistic regression to identify the independent predictors of the occurrence of PSH. Statistical significance was defined as a p value less than 0.05.

Patient characteristics

From June 2014 to July 2020, a total number of 369 rectal cancer patients underwent APRs in West China Hospital, Sichuan University. 64 patients were excluded because of incomplete or lost personal information. Eventually, 305 rectal cancer patients were included in the current study, including 103 in the extraperitoneal group and 202 in the transperitoneal group (Fig. 1). The median follow-up time was 33 (interquartile range, 17–46) months, with no significant differences in the follow-up intervals or patient characteristics between the groups (Table 1).

Table 1

Patient characteristics
	Extraperitoneal group (n = 103)	Transperitoneal Group (n = 202)	p value
Sex, n (%)			0.586
Male	63 (61.1)	117 (57.9)
Female	40 (38.9)	85 (42.1)
Age (years)*	59.62 ± 13.50	57.04 ± 13.61	0.158
BMI (kg/m²)*	22.30 ± 2.99	23.71 ± 2.87	0.106
Comorbidity, n (%)
DM	7 (6.8)	18 (8.9)	0.364
COPD	8 (7.8)	13 (6.4)	0.530
Benign prostatic hypertrophy	7 (6.8)	11 (5.4)	0.584
ASA score, n (%)
I/II/III	0/81/22 (0/78.6/21.4)	0/158/44 (0/78.2/21.8)	0.932
Tumor Stage, n (%)
I/II/III/IV	4/30/55/14 (3.9/29.1/53.4/13.6)	11/66/100/25 (5.4/32.6/49.5/12.5)	0.827
Surgical approach, n (%)
Laparoscopic	67 (65.0)	117 (57.9)	0.229
Open	36 (35.0)	85 (42.1)
Neoadjuvant therapy, n (%)
No	41 (39.8)	58 (28.7)	0.051
Yes	62 (60.2)	144 (71.3)
Duration of operation (min)*	209.47 ± 24.23	210.00 ± 24.42	0.913
Blood loss, (mL)*	90.67 ± 116.42	84.43 ± 41.92	0.054
Follow-up duration (months)*	33.58 ± 6.73	34.60 ± 7.57	0.102
BMI body mass index; DM diabetes; COPD chronic obstructive pulmonary disease
*Data was shown as mean (SD).

Follow-up Outcomes

Clinically and radiologically detectable parastomal hernias were present in 76 of 202 (37.6%) and 14 of 103 (13.6%) subjects in the transperitoneal and extraperitoneal groups during the follow-up period. 10 of 76 (13.1%) subjects in the transperitoneal group and 2 of 14 (14.3%) subjects in the extraperitoneal group underwent a parastomal hernia operation during the follow-up. Indications for parastomal hernia repair are detailed in Table 4. Kaplan–Meier curves of the occurrence of PSH have been illustrated (Fig. 3). Some type of stoma-related complication (Table 2) was reported in the transperitoneal group and extraperitoneal group. Except for parastomal hernias, 3 patients were readmitted, including 2 for adhesive bowel obstruction and 1 for pelvic infection in the extraperitoneal group; 7 patients were readmitted, including 4 for adhesive bowel obstruction, 2 for anastomotic prolapse and 1 for anastomotic stenosis in the transperitoneal group.

Table 2

Follow-up outcomes.
	Extraperitoneal group (n = 103)	Transperitoneal group (n = 202)	p value
Postoperative mortality, n (%)	0	0	N
Peristomal morbidity, n (%)
Peristomal infection	3 (3.0)	7 (3.4)	0.896
Stoma bleeding	2 (2.0)	5 (2.5)	0.810
Mucocutaneous separation	0 (0)	2 (1.0)	0.163
Anastomotic stenosis	3 (3.0)	8 (4.1)	0.653
Anastomotic prolapse	6 (6.0)	10 (5.0)	0.737
Parastomal hernia	14 (13.6)	76 (37.6)	<0.01
Type I (≤ 5 cm, no cIH)	7 (6.8)	31 (15.3)
Type II (≤ 5 cm, with cIH)	4 (3.9)	22 (10.9)
Type III (> 5 cm, no cIH)	0 (0)	6 (3.0)
Type IV (> 5 cm, with cIH)	3 (3.0)	17 (8.4)
Adhesive bowel obstruction, n (%)	2 (2.0)	12 (5.9)	0.157
Incision or pelvic infection, n (%)	11 (10.7)	10 (5.0)	0.390
cIH = concomitant incisional hernia.

The Univariate And Multivariate Analyses For The Occurrence Of Parastomal Hernia

Potential variables (p < 0.05 in the univariate analysis) were selected for further multivariable analysis, including older age (p<0.001), blood loss (p = 0.016), higher BMI (p = 0.018), and the transperitoneal route of stoma creation (p<0.001). In the multivariable logistic regression analysis, the transperitoneal approach of colostomy (p = 0.002), older age (p<0.001), and higher BMI (p = 0.013) were identified as independent risk factors for the occurrence of PSH (Table 3)

Table 3

Univariate and multivariate analysis for parastomal hernia formation after permanent colostomy.
	PSH (n = 90)	No-PSH (n = 215)	Univariate p value	Multivariate p value	OR (95%CI)
Sex, n (%)			0.054
Male	41 (45.5)	84 (39.07)
Female	49 (54.5)	131 (60.93)
Age (years)	62.11 ± 11.58	56.11 ± 13.54	<0.001	<0.001	1.070 (1.043–1.090)
BMI (kg/m²)	22.36 ± 3.16	23.56 ± 2.56	0.018	0.013	1.523 (1.188–2.197)
Comorbidity
DM	9 (10.0)	16 (7.4)	0.425
COPD	4 (4.4)	17 (7.9)	0.276
Benign prostatic hypertrophy	5 (5.5)	13 (6.0)	0.724
ASA score
I/II/III	0/70/20 (0/77.8/22.2)	0/169/46 (0/78.6/21.4)	0.226
Tumor stage
I/II/III/IV	7/30/41/12 (7.8/33.3/45.5/13.4)	8/66/114/27 (3.7/30.7/53.0/12.6)	0.206
Stoma creation approach, n (%)			< 0.001	0.002	5.946 (2.834–12.47)
Extraperitoneal	14 (15.6)	89 (41.3)
Transperitoneal	76 (84.4)	126 (58.7)
Surgical approach, n (%)			0.760
Laparoscopic	49 (54.5)	135 (62.8)
Open	41 (45.5)	80 (37.2)
Neoadjuvant chemoradiotherapy, n (%)	63 (70.0)	143 (66.5)	0.584
Operation time, (min) *	210 ± 35.95	209.69 ± 33.68	0.507
Blood loss, (mL) *	85.33 ± 136.50	79.48 ± 50.16	0.016	0.062	1.005(0.988–1.910)
PSH parastomal hernia; BMI body mass index; DM diabetes; COPD chronic obstructive pulmonary disease
*Data was shown as mean (SD).

Table 4

Patients with parastomal hernia repair.
Group	Patient, age(years) at repair	Time of repair (months from APR)	Indications of surgery	Technique of repair
Trans-	Female, 76	32	Severe protrusion of contents of the abdominal cavity	Keyhole
Trans-	Female, 86	11	Severe protrusion of contents of the abdominal cavity; pain	Keyhole
Trans-	Male, 65	9	Large prolapse with parastomal hernia; pain	Sugarbaker
Trans-	Female, 56	25	Stoma appliance leakage; Problems with skin	Keyhole
Trans-	Female, 74	21	Severe protrusion of contents of the abdominal cavity; pain	Keyhole
Trans-	Female, 67	19	Severe protrusion of contents of the abdominal cavity; Problems with skin	Keyhole
Trans-	Female, 78	26	Pain, episodes of small-bowel obstruction	Keyhole
Trans-	Male, 80	39	Severe protrusion of contents of the abdominal cavity	Sugarbaker
Trans-	Female, 78	13	Severe protrusion of contents of the abdominal cavity	Keyhole
Trans-	Female, 62	24	Problems with stoma dressing	Keyhole
Extra-	Male, 60	29	Severe protrusion of contents of the abdominal cavity	Keyhole
Extra-	Male, 81	16	Emergency operation for small-bowel obstruction	suture repair

In this study, we compared the short-term rate of parastomal hernia reparations between patients with the extraperitoneal and transperitoneal groups for permanent colostomies. Meanwhile, it highlights the rate of parastomal hernias, the incidence of complications, and the risk factors of parastomal hernias. The most important findings of our study are that, although the incidence of parastomal hernias was significantly lower in the extraperitoneal, the short-term rate of parastomal hernia reparations was nearly the same between the groups, and the incidence of complications was nearly the same too. In addition, older age, higher BMI, and transperitoneal colostomies were identified as independent risk factors for the formation of PSH.

Several meta-analyses and reviews^[20–23] advocated that the mesh reinforcement of the permanent colostomy site is both safe and effective in preventing parastomal hernias compared with conventional stoma formation without mesh. However, several stuies have been published in recent years argued that prophylactic mesh did not decrease the rate of detectable parastomal hernias,^{[14, 24–26]} and the cost of mesh is expensive. Conventional end colostomies are still widely used worldwide, especially in developing countries. We advocated that there is no significant difference in the probability of parastomal hernia reparations for patients who have developed parastomal hernia, although permanent colostomy via an extraperitoneal route had more advantages than transperitoneal colostomy.^[27–29] Therefore, for patients who have developed a parastomal hernias, attention and follow-up should not be reduced just because they have adopted a better approach to colostomy.

To our knowledge, higher BMI, older age, female sex, larger aperture size, transperitoneal stoma creation, and larger waist circumference have been confirmed to be independent risk factors for parastomal hernia in Europe.^{[8, 30, 31]} This is following the conclusion of the current study that identified older age and higher BMI as independent risk factors for the formation of PSH. Old and overweight patients tend to have increased intra-abdominal pressure and weakened abdominal wall tension, which means that the terminal colon easily protrudes out of the abdominal wall along the ostomy path.^{[17, 32, 33]} This point is following a previous study that recorded worse muscular atrophy on the medial side of the stoma among elderly and obese patients and confirmed that weakened abdominal muscle may lead to PSH formation.^[7] Therefore, elder and obese patients should be informed of the risks of PSH as soon as possible, and they should be advised to undergo muscle exercises and to wear support products to reduce the occurrence of PSH.^[34]

To reinforce the abdominal wall, Goligher et al. introduced extraperitoneal colostomy. By forming a tunnel outside the peritoneum, the extraperitoneal approach eliminates the lateral space with its potential for obstruction.^[5] The extraperitoneal route also provides additional coverage of the lateral peritoneal flap, which strengthens the abdominal wall to some extent and leads to a more evenly distributed pressure with the lateral peritoneal flap.^{[11–13, 16, 17]} According to previous studies, the extraperitoneal approach has been reported to have a significantly lower risk of herniation than the transperitoneal route among patients with permanent stomas.^[14] A meta-analysis including five randomized controlled trials^[10] also reported a lower incidence of parastomal hernia in the extraperitoneal route than in the transperitoneal route.

Although extraperitoneal colostomy requires longer operation time and more complex surgical procedures.^[35] the follow-up results do not show more related complications. Therefore, we believe that extraperitoneal colostomy is worth recommending for experienced surgeons, and to avoid multiple risk factors at the same time, we strongly recommend extraperitoneal colostomy for elderly or obese patients to prevent the occurrence of parastomal hernia. Some asymptomatic parastomal hernias have been seen in the CT scan, but not on clinical examination. Meanwhile, the correlation between hernia rates diagnosed via clinical examination and by CT scan is poor. We thought those herniations through the hole of the stretched aperture in the abdominal wall resulted in a high rate of subclinical parastomal hernias detected on the CT scan images.

There are some limitations in our study. First, due to the retrospective study design, selection bias and recall bias may have been introduced. Whether to use an extra- or transperitoneal approach was largely determined by the intraoperative judgment of different surgeons. Second, considering this is a retrospective study, we lack a survey on the postoperative quality of life of patients with different colostomy methods. Third, since all PSHs were diagnosed through surveillance CT, the initial diagnosis time depended on the interval of CT imaging. Finally, there are fewer comorbidities including DM, COPD, etc. while these do not appear to reach significance, maybe the numbers of patients are too small to detect a significant difference. Therefore, it remains unknown whether there are other risk factors.

In this study, although the incidence of parastomal hernias was significantly lower in the extraperitoneal, the short-term rate of parastomal hernia reparations was nearly the same between the groups, and furthermore, the incidence of complications was nearly same too. In addition, older age, higher BMI, and transperitoneal colostomies were identified as independent risk factors for the formation of parastomal hernia.

Funding:

1. This study was supported by the Department of Science and Technology of Sichuan Province (Award Number 2021YFS0025); 1·3·5 project for disciplines of excellence, West China Hospital, Sichuan University (No. 2019HXFH031; 20HXJS003)

Author contributions:

Jianlin Xiao: Resources; writing-original draft; writing-review and editing.

Yu Shen: Writing-review and editing.

Mingtian Wei & Xuyang Yang: Writing-review and editing.

Hanjiang Zeng: Conceptualization; resources.

Wenjian Meng: Conceptualization; resources; supervision.

Ziqiang Wang: Conceptualization; methodology; writing-review and editing.

Conflict of interest:

The authors declare no conflict of interest.

Ethics approval:

The Institutional Review Committee of West China Hospital of Sichuan University approved this study. The study was registered at Chinese Clinical Trial Registry (Identifier: ChiCTR2200056134). The requirement for informed consent was waived due to the retrospective nature of the study.

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The same rate of parastomal hernia reparations in the different approaches to colostomy

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Abstract

Backgrounds

Methods

Results

Conclusions

Figures

Introduction

Materials And Methods

Patients and study design:

Surgical Technique

Data Collection

Statistical analysis:

Results

Patient characteristics

Follow-up Outcomes

The Univariate And Multivariate Analyses For The Occurrence Of Parastomal Hernia

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1