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Table of Contents
ORIGINAL ARTICLE
Year : 2019  |  Volume : 2  |  Issue : 1  |  Page : 12-15

Endoluminal negative pressure therapy (Endo-SPONGE) for anastomotic leaks following transanal total mesorectal excision: Our experience


1 Department of Colorectal surgery, University Hospital Coventry and Warwickshire, Coventry, England, United Kingdom
2 Department of Colorectal surgery, Sandwell and West Birmingham NHS Trust, West Bromwich, England, United Kingdom

Date of Submission24-Dec-2019
Date of Decision05-Mar-2020
Date of Acceptance01-May-2020
Date of Web Publication30-May-2020

Correspondence Address:
Dr. Diwakar Ryali Sarma
Rugby, Warwickshire, CV230GN
United Kingdom
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/IJCS.IJCS_6_19

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  Abstract 


Introduction: The management of anastomotic leaks in rectal cancer surgery poses a huge challenge, especially in patients developing a leak post transanal total mesorectal excision (taTME). Endoluminal negative pressure therapy is a minimally invasive method of managing the situation effectively and most times preventing a highly morbid reoperation. Aim: The aim was to study the effectiveness and safety of Endo-SPONGE therapy in the management of anastomotic leaks following taTME. Methods: We looked at our data spanning 4 years of patients developing anastomotic leaks following taTME and their management. The primary outcome measure was complete closure of the anastomotic leak and/or abscess cavity. The secondary outcome measures included the length of stay, stoma closure, and complication rates. Results: Nine patients from our series had anastomotic leak following taTME, four of which had endoluminal negative pressure therapy and were included in the study. These were all male patients and had either T2 or T3 tumor. The median age was 59 years, with a median American Society of Anesthesiologists grade of II and the most common comorbidity being diabetes mellitus (75%). The mean average body mass index of these patients was 25, and the initial (taTME) preoperative P-POSSUM morbidity and mortality median was 49 and 3%, respectively. The median distance of the anastomosis was 4 cm from the external anal sphincter. A median of six Endo-SPONGE was used per patient with a 100% success rate. Low negative pressure was advocated in all cases (80–110 mmHg). The average length of stay was 57 days. The most frequent complication of the Endo-SPONGE was a presacral abscess, followed by stenosis of the anastomosis. There were no mortality in the Endo-SPONGE group and no local recurrence of cancer. Conclusion: Introduced in the early 21st century, endoluminal negative pressure therapy is a viable option to consider for the management of anastomotic leak following low rectal anastomosis in taTME. Our initial experience with Endo-SPONGE is promising and was able to prevent high-risk redo operations or Hartmann's procedures in the select group of patients, thereby not impairing the quality of life significantly.

Keywords: Anastomotic leak, complications of transanal total mesorectal excision, endoluminal negative pressure therapy, Endo-SPONGE, rectal surgery


How to cite this article:
Sarma DR, Bhattacharya P, Joy H. Endoluminal negative pressure therapy (Endo-SPONGE) for anastomotic leaks following transanal total mesorectal excision: Our experience. Indian J Colo-Rectal Surg 2019;2:12-5

How to cite this URL:
Sarma DR, Bhattacharya P, Joy H. Endoluminal negative pressure therapy (Endo-SPONGE) for anastomotic leaks following transanal total mesorectal excision: Our experience. Indian J Colo-Rectal Surg [serial online] 2019 [cited 2020 Sep 29];2:12-5. Available from: http://www.ijcrsonweb.org/text.asp?2019/2/1/12/285426




  Introduction Top


Anastomotic leak remains the most feared complication in colorectal surgery. The literature reports a leak rate as high as 11% with even higher rates seen in very low rectal cancers, especially where the distal resection margin and the anastomosis are <5 cm from the anal verge.[1]

Anastomotic leaks are associated with high morbidity and mortality. Consequently, every effort is made perioperatively to prevent this complication, and when they do occur, early recognition and prompt management is essential to prevent an adverse outcome.

At present, the majority of the patients undergoing a transanal total mesorectal excision (TaTME) procedure will be defunctioned with the creation of an ileostomy to “protect” the anastomosis. Anastomotic breakdown may necessitate an emergency laparotomy and the formation of a permanent stoma.

A retrospective study of the TME trial showed that the incidence of stoma reversal was almost halved in patients undergoing further surgery for an anastomotic leak.[2] This has enormous physical and psychological implications for this cohort of patients.

To prevent this, various conservative techniques have been developed to manage anastomotic leaks, particularly in low rectal cancers, and these include endoluminal glue and endoscopically placed stents.[3] The results with fibrin glue are generally poor, and colonic stents have their own associated complications, including stent migration.

To overcome these problems, a novel technique was introduced in 2002 using endoluminal negative pressure to manage low anastomotic leaks. The procedure involves examination of the anastomosis under anesthesia, assessing for dehiscence, and drainage of any perianastomotic collections/abscesses. The defect in the bowel anastomosis is accurately defined and recorded. The Endo-SPONGE (foam – open-pored polyurethane sponge) is then inserted into the defect under direct vision and connected to a negative low-pressure system. This then acts as a suction device to promote healing and prevents more invasive procedures. The device is managed on the surgical ward and changed in theater under anesthetic every 3–4 days for a few weeks until the cavity successfully seals, or the size of the defect is negligible or becomes amenable to suture closure.

The Endo-SPONGE device works through facilitating continuous drainage of any collection or abscess and encourages granulation at the site of an anastomotic leak by promoting neovascularization.

We looked at the effectiveness of this device (Endo-SPONGE) on the management of our patients developing an anastomotic leak following a TaTME procedure for low rectal cancer.


  Methods Top


Patient characteristics

All patients with anastomotic leak following a TaTME for low rectal cancer were included in the study. Patients managed with the negative pressure device were further analyzed retrospectively. The diagnosis of the anastomotic leak was made by axial imaging in the form of a computed tomography (CT) scan of the pelvis. Imaging demonstrating partial anastomotic breakdown was further assessed with evaluation and direct visualization under anesthesia, and if appropriate, the Endo-SPONGE device was inserted at this time.

All patients had a defunctioning ileostomy created at the time of their initial surgery (TaTME). The median age of these patients was 59 years, with a median body mass index (BMI) of 25, a median American Society of Anesthesiologists (ASA) grade of II, and a median distance of the anastomosis from the anal verge of 4 cm [Table 1]b.
Table 1:

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The device

The Endo-SPONGE device used in our institution was the standard issue manufactured by B. Braun Medical, Melsungen, Germany, and given approval for use by the trust's ethics committee.

The Endo-SPONGE is connected to a suction bottle and is maintained on a low negative pressure setting. The introduction of the sponge is through a prepackaged lubricated tube using a pushing device, while simultaneously retracting the outer plastic tubing. The final position is then checked under direct vision. The Endo-SPONGE is changed every 3–4 days to prevent the tissue from growing into the sponge making it difficult to retract and remove it. Further, Endo-SPONGE changes take place until the cavity seals.

Data collection

Retrospective data collection and analysis was done. Case notes of the patients were extracted from the medical records department. The data input included patient demographics, preoperative quality of life, performance score, site and distance of tumor and anastomosis from the anal verge, type of stapler device used, any intraoperative complications, preoperative chemotherapy or radiotherapy, preoperative P-POSSUM scoring, timing of the first Endo-SPONGE device insertion from the time of leak diagnosis, total number of Endo-SPONGE changes, duration of treatment, length of stay in hospital, short-term outcomes, reversal of ileostomy, and postoperative quality of life .

Statistical analysis

Categorical data are presented as frequencies or percentages. Continuous data are presented as a range (median values) unless otherwise specified. For the comparison of categorical variables, Fisher's exact or Chi-square test was used. A P value of 5% or lower was considered as being statistically significant. Statistical analysis was performed using SPSS software version 14.0.2 (IBM limited, UK).


  Results Top


In our cohort, a total of nine patients had an anastomotic leak following TaTME (1.6% of all taTME). All patients had standard resection with complete splenic flexure mobilization, flush ligation of the inferior mesenteric artery and stapled anastomosis with circular stapler size 29, and had a leak test performed at the end of the stapled devise being fired to check for any leak, and no drains were left in situ. None of the patients demonstrated any intraoperative anastomotic leak on leak testing. Anastomotic leak was diagnosed by axial imaging in the form of a CT scan of the pelvis. Imaging demonstrating partial anastomotic breakdown was further assessed with evaluation and direct visualization under anesthesia, and if appropriate, the Endo-SPONGE device was inserted at this time. Endoluminal negative pressure therapy was used to manage four of these patients. Five patients were not suitable for consideration of endoluminal therapy, either because there was a complete blow out of the anastomosis requiring redo operation or minimal leak without collection, managed with intravenous antibiotics and conservative approach.

All four were male patients and had T2 (3) or T3 (1) tumor, with a median distance of 4 cm from the anal verge. One patient had an open TaTME operation, and the remainder was done laparoscopically. One of the four patients received neoadjuvant chemoradiotherapy. Defunctioning ileostomy was created at the time of the primary operation (TaTME) in all cases [Table 1]a.

The median age was 59 years, with a median ASA grade of II and the most common comorbidity being diabetes mellitus (3 of 4). The mean average BMI of these patients was 25, and the initial (TaTME) preoperative P-POSSUM morbidity and mortality median was 49 and 3%, respectively.

Endo-SPONGE treatment was advocated within the same week of diagnosis of the anastomotic leak. A median of six Endo-SPONGE was used per patient with a 100% success rate. Low negative pressure was advocated in all cases (80–110 mmHg). The average length of stay in hospital was 57 days. Closure of the anastomotic leak was achieved in all cases, with a median duration of treatment of 48 days. The most frequent complication of the Endo-SPONGE was a presacral abscess formation, followed by anastomotic stenosis. There were no mortality recorded in the Endo-SPONGE group and no local recurrence of cancer. Two of the four patients had their ileostomy reversed as planned, one patient from this group declined further surgery (ileostomy reversal), and the fourth is currently awaiting surgery. The median follow-up of the patients post Endo-SPONGE treatment is 87 days.


  Discussion Top


Anastomotic leaks, especially in low rectal cancers, are associated with significant morbidity and mortality and remain a challenge to diagnose and treat.[4] Negative pressure endoluminal therapy has been developed as a novel method of conservatively managing leaks. Several studies on Endo-SPONGE use have shown promising results, and this has also been replicated in our cohort of patients.

Chronic pelvic sepsis associated with low anastomotic leaks impairs tissue healing and neorectal function following the reversal of ileostomy.[5],[6] Endo-SPONGE treatment offers tissue healing and better long-term outcome for these patients.

There are still no validation on the duration of Endo-SPONGE treatment and frequency of change of the device. In the CLEAN study, Borstlap et al. reported a 70% success rate after 14 months in their case series when suturing was done 13 days (mean) after the initiation of Endo-SPONGE therapy.[7] There is a wide variation in practice in this regard. In our series, 75% of the cases were left for spontaneous resolution and healing of the abscess cavity.

The literature supports the results of our study. Nagell and Holte report of the first four patients demonstrated a median healing time of 51 days.[8] Later studies by Weidenhagen reported 97% definitive closure rates,[9] and Mees et al.[10] cases with presacral abscess had a median closure time of 45 days. There is paucity in the literature on effective mode of treatment of low rectal anastomotic leaks and insufficient evidence to suggest that Endo-SPONGE therapy is superior to other conservative measures. Our study does highlight the improved efficacy and safety of this treatment modality.


  Conclusion Top


Our early experience with endoluminal negative pressure therapy is promising. This modality of treatment is well tolerated and avoids a redo laparotomy or a redo anastomosis, both of which inherently carry a high complication rate. The timing of initiation of Endo-SPONGE treatment appears to be the single most important factor in improved outcome. Further studies with a larger cohort of patients would benefit future strategies on the management of rectal anastomotic leaks using these suction devices.

Acknowledgment

We would like to acknowledge Mr. H. Joy, colorectal surgeon, Sandwell and West Birmingham, NHS Trust.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Shogan B, Carliste E, Alverdy J, Umanskiy K. Do we know why colorectal anastomoses leak? J Gastrointest Surg 2013;17:1698-707.  Back to cited text no. 1
    
2.
den Dulk M, Smit M, Peeters CM, Kranenbarg EM, Rutten HJ, Wiggers T, et al. A multivariate analysis of limiting factors for stoma reversal in patients it rectal cancer entered into the total mesorectal excision (TME) trial: A retrospective study. Lancet Oncol 2007;8:297-303.  Back to cited text no. 2
    
3.
Chopra S, Mrak K, Heunerbein M. The effect of endoscopic treatment on healing of anastomotic leaks after anterior resection of rectal cancer. Surgery 2009;145:182-8.  Back to cited text no. 3
    
4.
Ptok H, Marusch F, Meyer F, Schubert D, Gastinger I, Lippert H. Impact of anastomotic leakage on oncological outcome after rectal cancer resection. Br JSurg 2007;94:1548-54.  Back to cited text no. 4
    
5.
Hallbook O, Sjodahl R. Anastomotic leakage and functional outcome after anterior resection of the rectum. Br J Surg 1996;83:60-2.  Back to cited text no. 5
    
6.
Nesbakken A, Nygaard K, Lunde OC. Outcome and late functional results after anastomotic leakage following mesorectalexcision for rectal cancer. Br J Surg 2001;88:400-4.  Back to cited text no. 6
    
7.
Borstlap W, Musters G, Stassen L. Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: The clean study. Surg Endosc 2018;32:315-27.  Back to cited text no. 7
    
8.
Nagell CF, Holte K. Treatment of anastomotic leakage after rectal resection with transrectal vacuum-assisted drainage (VAC). A method for rapid control of pelvic sepsis and healing. Int J Colorectal Dis 2006;1:657-60.  Back to cited text no. 8
    
9.
Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surg Endosc 2007;2:1818-25.  Back to cited text no. 9
    
10.
Mees ST, Palmes D, Menninger R, Senninger N, Haier J, Bruewer M. Endo-vacuum assisted closure treatment for rectal nastomotic insufficiency. Dis Colon Rectum 2008;51:404-10.  Back to cited text no. 10
    



 
 
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