The Operative Morbidity in Creation and Closure of Loop Ileostomy

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1 J Soc Colon Rectal Surgeon (Taiwan) September 2007 Original Article The Operative Morbidity in Creation and Closure of Loop Ileostomy Chiao-Sen Wu Hwei-Ming Wang Joe-Bin Chen Te-Hsin Chao Hsiu-Feng Ma Chou-Chen Chen Feng-Fan Chiang Division of Colorectal Surgery, Department of Surgery, Veterans General Hospital, Taichung, Taiwan. Key Words Anastomotic leak; Loop ilestomy; Total mesorectal excision; Reoperation Running title: Loop Ileostomy Background. The de-functioning loop ileostomy was introduced as a technique to create a stoma that could divert the fecal stream from a more distal anastomosis in order to reduce the consequences of any anastomotic leakage or decompress a distal malignant tumor obstruction. However, the clinical value of this procedure is still being challenged. This study aimed to review the clinical utility of performing a diverting loop ileostomy in patients undergoing colorectal surgery and associated morbidity and mortality. Methods. A retrospective chart review was undertaken of a colorectal database at Veterans General Hospital, Taichuang. The indications and types of operation performed were reviewed. The main end-points included: (1) the incidence of sotma-related complications between creation and closure of loop ileostomy; (2) the mortality rate, re-operation rate, and morbidity associated with closure of the stoma. This review took data from Jan 01, 2003 to Dec 31, 2005, with a total of 203 patients receiving procedures for diverting loop ileostomy. The majority of patients received operations for colorectal cancer. The procedures included total mesorectal excision with coloanal anastomosis, low anterior resection, emergent decompression and reversal of Hartmann s procedure. Results. 144 patients (70.93%) received closure of loop ileostomy and the other 59 patients (29.07%) did not receive closure of loop ileostomy. After creation of a diverting loop ileostomy, electrolyte imbalance/dehydration was seen in 22 patients (10.83%), severe peristomal dermatitis in 4 patients (1.97%), peristomal bleeding in 1 patient (0.49%) and intestinal obstruction in 1 patient (0.49%). After closure of ileostomy, 3 patients (2.08%) developed anastomotic leakage, 3 patients (2.08%) developed wound infections, 2 patients (1.38%) developed distal obstruction and 1 patient (0.69%) developed a pelvic abscess. Conclusions. Creation and closure of the diverting loop ileostomy is associated with no mortality was seen in patients undergoing colorectal surgery in our study. [J Soc Colon Rectal Surgeon (Taiwan) 2007;18:73-80] The consequences of an anastomotic leakage can be devastating in patients undergoing colorectal surgery, especially in high risk rectal surgery. These consequences can include not only death, but also the requirement for re-operation, multiple organ failure, admission to an intensive care unit, and permanent Received: April 2, Accepted: September 18, Correspondence to: Dr. Chiao-Sen Wu, Division of Colorectal Surgery, Veterans General Hospital, No. 160, Sec. 3, Chung-Kang Road, Taichung, Taiwan. Tel: ; Fax: ; charves.wu@gmail.com 73

2 74 Chiao-Sen Wu, et al. J Soc Colon Rectal Surgeon (Taiwan) September 2007 stoma formation. There are also long-term consequences such as anastomotic strictures, reduced cancer survival, and poor defecation function. The overall negative effect on quality of life and the financial implications are considerable 1-4. The idea of creating a de-functioning stoma was in response to the problems associated with anastomoses with a high risk of a leak. The anastomoses currently thought to be at a high risk of leakage are low anterior resections, total mesorectal excision with coloanal anastomosis and reconstruction ileoanal procedures. The purpose of the stoma was focused on reducing the devastating consequences of an anastomostic leakage rather than just preventing a leakage. Currently, the principal argument is that because anastomotic leakage rate is relatively low, and the stoma is associated with considerable morbidity, the overall benefit to a population of patients is minimal if not harmful. So the routine use of diverting loop ileostomy is still controversial. The aim of the present study was to review the clinical practice of performing a diverting loop ileostomy in patients undergoing colorectal surgery and the associated morbidity and mortality after closure of the stoma. Methods Taichung Veterans General Hospital is a 1500-bed public teaching hospital that is a tertiary referral center for the local health region. The study used the Taichung Veterans General Hospital (Taichung, Taiwan) administrative database of the colorectal surgery department and we identified all patients who had a surgical procedure that resulted in a stoma of the small intestine or colon. Only the patients admitted during a 3-year period from January 1, 2003 to December 31, 2005 were considered for review. This included 271 patients in total. From the database, we selected all those patients who had undergone a diverting loop ileostomy in order to protect a more distally placed anastomosis, divert the fecal stream for post-operation anastomotic leakage or decompress a distal malignant tumor obstruction. A chart review was undertaken to check for unplanned readmission between the creation and closure of an ileostomy. All procedures were performed by a board-certified surgeon or by a resident directly under his or her supervision. In our department, diverting loop ileostomy were created routinely in patients undergoing (1) total mesorectal excision with coloanal anastmosis for middle and lower rectal cancer in high risk patients; (2) emergent colon operations with primary anastomosis because of tumor obstruction or without adequate colon preparation. (3) the patients receiving pre-operation concomitant chemo-radiotherapy for middle and lower rectal cancer. The location of loop ileostomy was placed right lower quadrant of abdomen and the distance was routinely made at cm from the ileocecal fold. Ileostomies were also created to protect anastomoses that were considered high risk for developing leaks. The decision was based upon a number of factors that included (1)age; (2)underlying disease such as DM, HTN, CAD, Uremia and immunocompromised disease; (3)emergent surgery; (4)the presence of sepsis or abscess formation or gross peritoneal soiling; and (5)anastomosis that was thought to be at high risk of leakage; (6)for decompression of colonic obstruction. All data were collected on a standardized data collection form that included variables for: age, gender, procedure indication, elective/emergent status, closure method, and complication type. The study reviewed the mortality rate and morbidity associated with the creation and closure of the ileostomy. Major morbidity was defined as the presence of an anastomotic leak, or abscess formation within 30 days after closure of a loop ileostomy. The study also reviewed the prevalence and indications for patients not undergoing a reversal procedure. Prior to closure of the ileostomy, the primary anastomosis was examined by digital rectal examination, fiber colonoscopy, or contrast enema study to ensure healing of the anastomosis and no more persistent anastomotic leakage. The closures were either performed by a senior resident or a junior resident directly supervised by a chief resident or an attending staff. The ileostomy closure involved a circular incision around the stoma site and then dissection down into the peritoneal cavity. Upon full mobilization of the loop, either a side-to-side anastomosis using two

3 Vol. 18, No. 3 Loop Ileostomy 75 firings of linear stapler cutter or end-to-end anastomosis using the traditional hand-sewn method was undertaken. After stapling, any bleeding points along the staple line were oversewn to prevent possible post-operative anastomotic hemorrhage. As usual, the anterior and posterior fascial sheaths were was then closed by an interrupted figure-of-eight suture with Vicryl. After adequate irrigation and cauterization, the skin incision was then closed with interrupted mattress suture with Dermalon suture without placement of drainage tube. The mean, standard deviation and range were used as descriptive statistics. Results The general data of the patients that receiving a loop ileostomy was shown in Table 1. As shown in Table 1, the patients were classified as two groups: the first group received closure of loop ileostomy and the second group didn t receive closure of loop ileostomy. There was no difference between the two groups in age, gender or underlying disease. But there were differences in pathological stages and operation types. The stage IV patients in the non-closure group of patients (61.1%) were much higher compared to the closure group (10.2%). The study enrolled 12 patients that suffered from malignant intestinal obstruction because of local recurrence or peritoneal carcinomatosis who received loop ileostomy only for decompression and without closure. Sixteen patients received emergency tumor resection and diverting loop ileostomy, while 12 of them did not receive closure procedure due to post-operative morbidity/mortality or disease progression. Table 1. The General Data of the Patients Receiving Loop Ileostomy Closure gourp Non-closure group Number Age ± (33~88) a ± (26~86) a Gender Male to Female 90:54 37:22 Position of lesion Upper rectum Middle rectum Lower rectum 14 (10.4%) 62 (46.3%) 41 (30.6%) 3 (7.9%) 9(23.7%) 5(13.2%) Sigmoid colon 12 (9.0%) 4 (10.5%) Transverse colon 1 (0.7%) 5 (13.2%) Ascending colon 4 (3.0%) 12 (31.6%) Pathology Stage I II III IV 27 (21.3%) 41 (32.3%) 46 (36.2%) 13 (10.2%) Operation Type CAA d 100 (69.4%) Non-CAA d 2 (5.6%) 4(11.1%) 8(22.2%) 22 (61.1%) 13 (22.0%) 46 (78.0%) 44 (30.6%) Total ostomy days (17~651) a N/A b In-hospital stay (days) c (3~50) a N/A b Underlying disease DM CAD HTN Uremia a Mean SD (Range), b not available, 23 (16.0%) 11 (7.6%) 40 (27.8%) 4 (2.8%) c after closure of loop ileostomy, d coloanal anastomosis. 13 (22.0%) 6(10.2%) 16 (27.1%) 2 (3.4%)

4 76 Chiao-Sen Wu, et al. J Soc Colon Rectal Surgeon (Taiwan) September 2007 Indications for operation The indications and patient numbers for surgery were shown in Table 2. The group that receiving reversal of Hartmann s procedure all received diverting loop ileostomy because of low-lying anastomoses due to previous operation for middle rectal cancer and the anastomoses were thought to be at high risk of leakage. And within the 113 patients that received total mesorectal excision with coloanal anastomosis and loop ileostomy, the leakage rate of the distal anastomosis is 15.04% (17 in 103 patients). Table 2. The indications for the patients that received loop ileostomy Indication Creation Closure(%) Colorectal cancer (79.33%) Closure of end colostomy 5 5 (100%) Malignant intestinal obstruction a 28 4 (10.43%) Anastomotic leakage (62.5%) Other b 14 6 (42.86%) Total (70.94%) a including either primary tumor obstruction or tumor recurrence-induced obstruction. b including diverticulitis with perforation, colon adenoma, other malignancy with colorectal invasion, gastrointestinal bleeding and rectovaginal fistula. The prevalence and management of anastomotic leakage As the data shows in Table 3, 16 patients developed post-opeartive anastomotic leakage and received loop ileostomy for diversion of fecal stream to avoid further sepsis. Three patients were referred from other hospitals, only one of them received closure of ileostomy and two patients lost follow-up. Nine patients developed anastomotic leakage after laparosopic surgery. Ten of them received closure of loop ileostomy. The stoma-related complications prior to stoma closure The types of complications prior to stoma closure were shown in Table 4. However, the study was unable to determine if any patients in the study group were admitted to other regional hospitals with stoma-related complications during the study period. This is a major limitation of a retrospective chart review study, so the actual incidences of stoma-related complications may have been under-estimated 5. Table 3. The data of patients that developed anastomotic leakage after operation Patient No. Age Gender Lesion site Operation Pathology Stage Underlying disease Leakage time b Closure 1 56 F T-colon RH I CRI, HTN 8 th day Y 2 40 M Upper rectum LAR II No 3 rd day Y 3 54 M Rectum LAR a IIIB No N/A c Y 4 42 M D-colon LH II No 7 th day Y 5 45 F Upper rectum LAR II No 1 st day N 6 77 M T-colon T colectomy a N/A c No N/A c N 7 73 M D-colon LH 0(Tis) No 21 st day Y 8 64 M S-colon LAR II HTN 8 th day Y 9 39 M Lower rectum Closure of ileostomy I No 77 th day Y M A-colon RH IV No 4 th day N M A-colon RH III DM, CAD, HTN 13 th day Y M T-colon Colectomy with IRA IV CAD 19 th day N M S-colon AR III HTN 5 th day Y F A-colon, lower rectum APR+RH III DM 28 th day N M A-colon RH a N/A c No N/A c N M A-colon Closure of end colostomy Strangulated inguinal hernia No 3 rd day Y a Initially receiving operation at other hospital then transferred to our department after complication. b Time after operation, c Not available.

5 Vol. 18, No. 3 Loop Ileostomy 77 Table 4. The Type of Complications Between Creation and Closure of Loop Ileostomy Complication Numbers (%) Dehydration/electrolyte imbalance 22 (10.83%) Severe peristomal dermatitis 4 (1.97%) Peristomal bleeding Intestinal obstruction 1 (0.49%) 1 (0.49%) Total 28 (13.8%) The period between creation and closure of stoma and in-hospital stay after stoma closure As shown in Table 1, 144 patients received the procedure for closure of the loop ileostomy. At closure of the loop ileostomy, side-to-side anastmosis with GIA was performed in 113 patients an end-to-end anastomosis by the traditional hand-sewn method were performed in 30 patients. The average period between creation and closure of a loop ileostomy is days (17 to 651 days) and the average in-hospital stay for closure of an ileostomy is days. (3 to 50 days) After analyzing patient data, the shortest period of ileostomy was 17 days because the patient received emergent diverting loop ileostomy for decompression first then received right hemicolectomy and closure of loop ileostomy 17 days later. After operation, the patient recovered well and no complication occurred. The longest time for ileostomy was 651 days. The patient received pre-operation concomitant chemo-radiotherapy then received total mesorectal excision with coloanal anastomosis and diverting loop ileostomy for lower rectal cancer. However, post-operation leakage of the coloanal anastomosis occurred, so she refused to receive closure of loop ileostomy even after healing of the anastomosis. After almost two years later, because of poor life quality associated with a loop ileostomy, she received closure of the ileostomy and discharged eight days later without any complications. The longest hospitalization after closure was 50 days. The patient developed an anastomotic leakage on the eighth post-operation day and received another operation for diverting loop ileostomy and was discharged 37 days later. Table 5. The Types of Complications after Closure of Loop Ileostomy Complication Numbers(%) Leakage 3 (2.08%) Wound infection 3 (2.08%) Prolonged ileus 1 (0.69%) Intestinal obstruction 2 (1.38%) Pelvic abscess 1 (0.69%) Para-anastomotic abscess 1 (0.69%) Total 11 (7.59%) Complications after closure of loop ileostomy The complications after closure of loop ileostomy were shown in Table 5. The most severe complication was anastomotic leakage in three patients. (2.08% in the closure group) They all received side-to-side anastomosis with stapler cutter. (2.65% in the stapler cutter group) Four patients received reoperation after closure of loop ileostomy and the reoperation rate was 2.77%. Three of them suffered from anastomotic leakage and one patient suffered from parastomal abscess formation with peritonitis 77 days after operation. The Non-Closure Group The number of patients who did not receive closure of loop ileostomy was of them (20.33%) received loop ileostomy for decompression due to tumor recurrence with intestinal obstruction. Two of them (3.38%) received the procedure due to post-operation rectovaginal fistula for stool diversion. The majority of patients didn t receive closure of loop ilestomy due to disease progression, poor general condition or loss of follow-up. Discussion To prevent the consequences of anastomotic leakage, temporary diversion is relatively effective. However, the routine use of temporary diversion for middle and lower rectal cancer surgery is still controver-

6 78 Chiao-Sen Wu, et al. J Soc Colon Rectal Surgeon (Taiwan) September 2007 sial, so we reviewed the results of our department to evaluate the benefits and deficiency of creation a loop ileostomy, since the diversion itself is associated with some morbidity and ileostomy closure necessitates an additional surgical procedure. In our study, we adopted temporary diversion for patients considered at high-risk of an anastomotic breakdown after total mesorecctal excision with coloanal anastomosis, pre-operation concomitant chemoradiation, immunocompromised patients or emergent operations. Loop ileostomies are typically more difficult to manage than end ileostomies because the stoma frequently empties close to the skin surface. Some peristomal dermatitis, stomal leakage and peristomal bleeding have been reported. In our study, we frequently encountered complications prior to closure of a loop ileostomy such as dehydration/electrolyte imbalance (22 patients, 10.83%) and severe peristomal dermatitis (4 patients, 1.97%). Rare complications included peristomal bleeding (1 patient, 0.49%) and intestinal obstruction (1 patient, 0.49%). The majority of patients suffering from dehydration/electrolyte imbalance were treated at our emergency department with fluid and electrolyte supplement then discharged. However, the high incidence of dehydration/electrolyte imbalance may be due to the following reasons: (1) lack of enough education of stomal care to the patients and their families, (2) some patients not receiving regular follow-up at out patient department before closure of loop ileostomy and presented at emergent department with the symptoms of dehydration and electrolyte imbalance. Post-operative short bowel syndrome is not taken into consideration because the loop ileostomy was located at cm proximal to the ileocecal fold. Our incidence of peristomal dermatitis (1.97%) was less than has been reported by others. (13-15%) 6-7 The lower incidence of peristomal dermatitis maybe due to the following reasons, (1) the relatively more slender body of eastern patients than the western patients, so stomal creation and stomal care is much easier in eastern patients; and (2) the professionalism of our stomal care team and team members. However, the actual incidence of the peristomal dermatitis may be underestimated because of the limitations of this retrospective study. When a loop ileostomy is performed, it is usually closed once the anastomosis is well healed, e.g. six weeks to three months following the initial procedure. In our study, the morbidity of loop ileostomy between creation and closure was relatively low and the mean time for an ileostomy was ± days, and obviously was longer than six weeks to three months. The major causes were because (1) we included all patients that received closure procedure after initial operation and other studies included patients over a relatively short 12-month period; (2) our department was assigned with only thirty-one beds and one operation theater and the patients for closure of ileostomy were admitted only when bed and operation theater was available. So this could be a major cause of delay in closure of loop ileostomy. Compared with a prospective study by L. Balfour et al, that had a mean time of 28 weeks (18-48) after formation, our study was relatively short for mean time of ileostomy.(121 to 196 days) 8. The post-operative in-hospital stay in our study was 9.12±5.69 days and 8 days in the L. Balfour study 8. The leakages after closure of loop ileostomy all happened at the stapler cutter group. Past history was reviewed and no any significant risk factor such as DM, CAD, uremia or immunocompromised disease was identified. After review, the probable cause may be inappropriate appliance of the stapler cutter. However, further evaluation showed be done to identify the actual reason of leakage. As mentioned in the study of T. Cowan and A. G. Hill, that ileostomy closure without contrast study is safe in selected patients. 59 patients were enrolled and 35 patients had a contrast study. Two leaks and five strictures were found; however, no patient had pelvic sepsis after ileostomy closure. So they concluded that in patients with an ileostomy following anterior resection, with a clinically examinable anastomosis and a smooth post-operative course, a radiological examination of the anastomosis prior to ileostomy closure appears unnecessary. Some other studies have also shown that either digital or sigmoidscope examination of the anastomosis can rule out stricture, and that ileostomy reversal in healthy patients without prior radiological examination is not associated with increased complications. In our department, digital rectal examination or fiber colonoscopy was used to sur-

7 Vol. 18, No. 3 Loop Ileostomy 79 vey the healing of the anastomosis. Only one pelvic abscess (0.69%) was noted after closure of ileostomy and was resolved after antibiotic treatment. Compared with the aforementioned studies, pre-closure digital rectal examination and sigmoidoscope are quite reliable compared to contrast enema studies. In conclusion, construction of a loop ileostomy is associated with a moderate rate of complications approximately 14 percent in our study and as high as 70 percent in other series. Furthermore, closure of a loop ileostomy is associated with zero mortality rate. So diverting loop ileostomy is a feasible option in high risk patients to avoid the devastating consequences of anastomotic leakages. References 1. Poon RT, Chu KW, Ho JW, Chan CW, Law WL, Wong J. Prospective evaluation of selective defunctioning stoma for low anterior resection with total mesorectal excision. World J. Surg.1999;23: Dehni N, Schlegel RD, Cunningham C, Guiguet M, Tiret E, Parc R. Influence of a defunctioning stoma on leakage rates after low colorectal anastomosis and colonic J pouch anal anastomosis. Br. J. Surg. 2001;88: Leester B, Asztalos I, Polnyib C. Septic complications after low anterior rectal resection:is diverting stoma still justified? Acta Chir. Iugosl. 2002;49 : Machado M, Hallbook O, Goldman S, Nystrom PO, Jarhult J, Sjodahl R. Defunctioning stoma in low anterior resection with colonic pouch for rectal cancer:a comparison between two hospitals with a different policy. Dis. Colon Rectum 2002;45: Cameron P, Nigel B, Gregory M. Clinical utility of a de-functioning loop ileostomy. Aust N Z. J Surg. 2005;75: Chen F, Stuart M. The morbidity of defunctioning stomata. AustNZJSurg1996;66: Fasth S, Hulte n L. Loop Ileostomy:a superior diverting stoma in colorectal surgery. World J Surg 1984;8: Balfour L, Stojkovic S, Boyle K, Finan P, Burke D, Sagar P. The outcome of loop ileostomy closure: a prospective study. Br. J. Surg. 2002;89, Supplement 1, p June 2002.

8 80 吳喬森等 J Soc Colon Rectal Surgeon (Taiwan) 2007;18:73-80 原 著 環狀迴腸造口相關的手術併發症 吳喬森王輝明陳周斌趙德馨馬秀峰陳周誠蔣鋒帆 台中榮民總醫院 大腸直腸外科 目的環狀迴腸造口術是一種利用腸道造口來分流經過遠端腸道吻合的糞便以減低吻合洩漏併發症的技術 這手術的臨床使用仍然遭到質疑 本文主要在探討病人接受大腸直腸手術合併迴腸造口的臨床運用以及相關的併發症和死亡 方法本文是台中榮民總醫院大腸直腸外科的一篇回溯性探討 手術的適應症以及手術類型都有回顧 主要的重點包括 (1) 在造口關閉之前跟造口相關的併發症 ;(2) 跟造口關閉相關的死亡率, 再手術率以及併發症 從 2003 年初到 2005 年底, 總共有 203 位病人接受環狀迴腸造口手術 大部分的病人都是大腸直腸癌症 手術的類型包括直腸全切除合併大腸肛門吻合手術, 直腸低前位切除手術, 減壓手術以及終端大腸造口關閉手術 結果 144 位病人 (70.93%) 接受造口關閉手術,59 位病人 (29.07%) 沒有接受造口關閉手術 發生電解質不平衡以及脫水的有 22 位病人 (10.83%), 嚴重造口周圍皮膚炎有 4 位 (1.97%), 造口周圍流血有 1 位 (0.49%), 腸阻塞有 1 位 (0.49%) 關閉造口以後,3 位 (2.08%) 發生吻合洩漏,3 位 (2.08%) 發生傷口感染,2 位 (1.38%) 發生遠端阻塞,1 位發生骨盆腔膿瘍 結論在接受大腸直腸手術的病人施行迴腸造口關閉手術有零死亡率 關鍵詞 吻合洩漏 環狀迴腸造口 直腸繫膜全切除 再次手術