a Is Mechanical Bowel Preparation Mandatory for Elective Colon Surgery? A Prospective Randomized Study Edward Ram, MD; Yevgeni Sherman, MD: Ruben Weil, MD; Tali Vishne, MD; Dragan Kravarusic, MD; Zeev Dreznik, MD Background: Bowel preparation prior to colonic sur- gery usually includes anubiotic therapy together with me- chanical bowel preparation (MBP). Mechanical bowel preparation may cause discomfort to the patient, pro- longed hospitalization, and water and electrolyte imbal- ance. IL was assumed that with the improvere gical technique together with the use of more effective prophylactic antibiotics, it was possible that MBP would no longer be necessary Hypothesis: There isno statistical difference inthe post- operative results of patients who undergo elective colon resection with MBP as compared with those who have sno MBP. Design and Patients: The study includes all patients who had elective large bowel resection at Campus Golda between April 1, 1999, and March 31, 2002. Emergency operations were not included. The patients were ran- domly assigned to the 2 study groups (with or without MBP) according to identification numbers. All patients were treated with intravenous and oral antibiotics prior to surgery. The patients in the MBP group received Sol- fodex for bowel preparation, Results: A total of 329 patients participated in the study, 165 without MBP and Lo4 with MBP. The 2 groups were similar in age, sex, and type of surgical procedure. Two hundred sixty-cight patients (81.5%) underwent surgery owing to colorectal cancer and 61 patients (18.5%) owing to benign disease. The hospital- {zation period was longer in the bowel-prepared group (mean4SD, 8245.1 days) as compared with the non- prepared group (mean4SD, 8.0427 days). However, this difference was not statistically significant. The time un- Ul the first bowel movement was similar between the 2 groups: a mean SD of 4.21.3 days in the nonprepared group as compared with a meanaSD of 4341.1 days in the prepared group (P=Ns). Four patients (1.2%) died in the postoperative course owing to acute myocardial infarction and pulmonary embolism. Sixty-two patients (37.686) of the non-MBP group sulfered from postopera- tive complications as compared with 77 patients (46.9%) of the MBP group. Conclusion: Ourresultssuggest that noadvantage's gained by preoperative MBP in elective colorectal surgery Arch Surg. 2005;140:285-288 HE VALUE OF MECHANICAL bowel preparation (MBP) for elective colorectal sur- gery isdebatable, Mechani- ss The study population comprised adult pa tients admitted for elective colorectal surgery Author Affiliations: Division of General Surgery. Rabin Medhicl Center, Campus Golda, Petach Tikva Sacklet Medical School, Tel Aviv University, Tel Avis Isr cel bowel preparation aims to rid the colon and rectum of solid stool and fecal contents, o lower bacterial load, and to reduce the incidence of postopera live anastomotic and infectious compl cations, The majority of colorectal sur- .geons consider MBP a prerequisite for the prevention of complications of colorectal surgery. Despite tecent studies that con- tradict this view" the majority of eo- lorectal surgeons still continue to empha- size the importance of MBP. This article describes the results ofa pro- spective randomized clinieal trial designed to compare MBP and non-MBP in patients undergoing elective colorectal surgery fn the Division of General Surgery atthe Rabin Medical Center, Tel Aviv, Israel, between April 1, 1999, and March 31, 2002. ail patients gave their informed consent, and the study was ap proved by the hospital ethics committe. Pa tients were allocated to the 2 study groupe ac cording other identification numbers. Patients with even numbers received MBP (group 1), and patients with odd numbers did not re ceive MBP (group 2) STUDY PROTOCOL, Patients in both groups were excluded if they had taken antibiotics for the last 10 day’ be fore surgery or if there was evidence of infec tion. Patients undergoing emergency opers (©2003 American Medical Association. AI rights reserved, Downloaded From: http:/jamanetwork.com/ on 09/25/2017Table 1. Surpeal Procedurs Hemizaetomy, ight 8 mara) Hemiccactomy ek Fy 3% 7428) Sigmoiectory 0 4% 86261) Subtotal eoletomy 7 4 113) Abiominopaiel resection 18 16 34(103) Transverse cletomy 1 2 100) Potion estan a 2 50(t53) Low anterior rsecton 2 ‘7 0188) Table 2. Summary of General Parameters Preparation (= 109) Somer oes (10088 ge. ruan «$0 cares eaiteds Proopratve led wastuson 7 10 Postoperative lod transfusion 4 21 Nalgnarto benign sas rato rzeat 1520 Sugior-aiondagtoresident rato e104 8112 Arastomoss hand sent salar rao 10154 ‘6 Fistdlcton d, mean «$0 Agett 42413 ospal stay. mean «SD 82251 80427 Table 3. Mortality and Morbidity ional 212) 2 ound deiccnce 318) 2114 ‘Wound inaction 16(03) 10161) nate breakdown (08) 2112) Prattomot lesding Na 211) Abdominaipalieolacton 1 (0.6) 1108) snr ation 7143) 530 Pulmonary camplcstons 16 (08) 9655) Thrmbophlbis 15(01) 1607) aus 14185) 167 eagarotomy 2(12) 2112) ‘ibrvition: NR otal *Dataare presen as urbe (pt signa. tage). Plus were not tions were not included, Patients randomized to group 2 were excluded if they had bowel preparation for colonoscopy within bday prior to surgery. Patients undergoing proctectomy with low rectal anastomosts or surgery for polypoid lesion were also excluded, All patients were admitted 1 day before surgery and re ceived & low-residue dit. Parenteral hydration was given on the morning of surgery. For prophylaxis inall patients, 1 hour before induction we sed 500 mg of metronidazole intrave nowsly and | gof ceftriaxone. The same antibiotic prophylaxis was continued for 48 hours following the operation. One day before surgery all patients in group I received Soffodex (24g fof monobasic sodium phosphate and 0.9 g of dibasic sodium phosphate) or MBP. Possile complications were egistered daly After strgery, and patients were re-examined atthe outpatient clinic 1, 3, and 6 weeks following surgery. ‘Wound infection was indicated by the presence of pus or discharge resulting ina culture positive for bacteria. Abdomi- nal or pelvic infection comprised discharge or abscess, which was defined as a typical finding in ultrasonography oF com: pated tomography, and a culture positive for bacteria from the pancture or drain, Wound rupture was defined as clinical evi ‘eration. Anastomotic dehiscence was detected by radiologic {maging using water-soluble contrast. Investigation was un dertaken inthe presence of fever, tenesmus, abdominal pain, fF clinical signs of peritonitis. The operations were performed by a colorectal surgeon oF by a resident surgeon assisted by a consultant A midline inc son was ised i all patients STATISTICAL ANALYSIS Unpaired t test was used to compare various parameters between the 2 groups, such as mean age, hospital stay, and time to first defecation, and x test or Fisher exact test was used to calculate the differences in various complications between the 2 groups. Significance tests were 2-tailed with 95% confidence intervals, and a P value =.05 was consid cred significant, ass Between April 1, 1999, and March 31, 2002, 329 con- secuive patients underwent elective colorectal proce- dures for nonobstructive large bowel pathologic fea- tures (Fable 1). One hundred sixty-four patients (09 ‘men, 65 women) underwent surgery with MBI 165 (102 men, 63 women) did not have MBP. summarizes general parameters. There were more men than women in both groups (no statistical difference between the 2 groups, P=.79). The patients in each group were similar in age. Preoperatively (MBP, 17; non-MBP, 10) who had hemoglobin level lower than 9.5 g/dL received preoperative blood trans- fusion (P=.15). Sixty-two patients (MBP, 41; non-MBP, 21) received blood transfusion in the postoperative pe- riod (P<,005). The average hospital stay for patients in both groups was similar. Pathological examination of the resected specimens revealed that 268 patients (81.5%) had malignant disease, whereas 61 patients (18.5%) had benign disease such as irritable bowel dis- ease or diverticulosis (no statistical differences between the 2 groups). The majority of operations were per- formed by residents. The majority of anastomoses were colocolonic, colorectal, or coloanal; in only 42 patients (212.8%) was the anastomosis ileocolic. No statistical difference was found between the 2 groups. In most ceases, the anastomosis was performed by stapler tech- nique. Time to first defecation was similar in both groups. Postoperative complications are given in Table 3. The incidence of wound infection was higher in patients with, MBP: 16 (9.8%) as compared with 10 (6.1%) in the non- (©2003 American Medical Association. AI rights reserved, Downloaded From: http:/jamanetwork.com/ on 09/25/2017MBP group. The incidence of wound dehiscence, ab- dominal/pelvie collection, urinary tract infection, throm- bophlebitis, ileus, and anastomotic breakdown was not significantly different between the 2 groups. ‘Anastomotic bleeding occurred in 2 patients (1.2%) both in the non-MBP group. In one the bleeding stopped spontaneously, while the second required re- laparotomy and suturing of the stapler line. Anasto- motic breakdown occurred in 3 patients (1 with MPB and 2 without MBP) following anterior resection and was diagnosed on the basts of clinical findings that in- cluded signs of peritonitis or septicemia, fecal discharge from the surgical wound, worsening abdominal pain, fever, and diarrhea. Computed tomography and ultra. sonography were used to confirm the anastomotic leak mall 3 patients Pulmonary complications occurred more frequently in the MBP group: 16 patients (0.8%) vs 9 patients (5.5%) in the non-MBP group. This difference was not statisti- cally significant. Mortality occurred in 2 patients (1.2%) from each group. One patient died of massive pulmonary embo- lism on the eighth postoperative day, 2 patients died of cardiorespiratory failure, and the fourth patient died of respiratory failure on the fourth day following relapa- rolomy owing to anastomotic failure. Various secondary surgical procedures were carried out in 4 patients for anastomotic leak and bleeding in both groups. These included peritoneal lavage, abdominal drain- age, defunctioning colostomy in 3 patients, and suturing, of the stapler line in 1 patient with anastomotic bleeding. All together, no statistical difference in the frequency of complications was abserved between the 2 groups (P=.64). However, when the complications were catego- rized into a binary variable (yes/no complication), there was a tendency for fewer complications in the non-MBP group (36.4%) as compared with the MBP group (45.7%) (P=.08). Eee} Most surgeons use MBP for elective colorectal surgery However, the use of MBP in eleeuve colorectal surgery fs. controversial sue, The aim of MBP isto rid the co- Jon of solid stool, thus reducing the bacterial load and ‘minimizing the risk of infection and anastomotic com- plications It also enables the surgeon to perform intra operative colonoscopy and facilitates palpation of the entire colon during surgery. The disadvantages of MBP areclectolyte imbalance, dehydration, abdominal pain, bloating, fatigue, and the risk of perforation with en: mas, especially in the elderly population." Mechanical bowel preparation has been justified by Smith etal! in their experimental model suggesting that the passage ofa large fecal load can disrupt the healing anastomosisas compared with those individuals with an cmpty colon. On the other hand, Schein etal failed to find a difference in anastomotic healing between groups of animals with or without bowel preparation. Various prospective randomized studies,"”""° comparing pa- Uicnts with and without MBP, failed to show the benetit of MBP in reducing the rate of complications, There is no doubt that prophylactic antibiotic therapy playsa very important role in colorectal surgery. Keigh- ley et al” found that the combination of MBP and s)s- temic antibiotics provided the mos effective protection against wound infection. The role of MBP and prophy- lactic antibiotic therapy in preventing anastomotic de- Jhscence is unclear, despite some studies that describe a low incidence of anastomotic dehiscence.” LeVeen et al and Cohen etal have also shown the advantage of prophylactic antibiotis for colorectal anastomotic heal- {ng in the presence of fecal loading. Some studies" show thatanastomotic dehiscence ocetrs mainly alter low an- terior eseetion: in our study aso, the 3 cases of anasto- roti leak occurred after this procedure ‘Our study failed to show any increase in the rate of anastomotic breakdown in patients without MBP: only 2 patients (12%) from this group had anastomotic break down, However, the rate of wound infection was higher fn the group that received MBP, but this was not statis- tically significant when compared with those who did not receive i. Despite these results, we strongly emphasize the need for MBP in 2 instances: patients Who nged low ‘oF very low anterior resection and when surgery is per formed for polypoid lesion where palpatory and some- limes intraoperative colonoscopy is necessary. On the other hand, we recommend extreme cation Fegarding the use of MBP in patients with a tumor almost acchid- ing the lumen. Mechanical bowel preparation in these palicnts may cause large bowel obstruction necessital- fngemergeney operation that requny requis stoma To our knowledge, this isthe second prospective ran- dlomized study of its type that eludes more than 300 pa tients. Both studies filed to show any superiority of MBP. This prospective randomized study suggests that MBP is unnecessary for safe elective colonic and colorectal sr- ery, although itis recommended in selected eases whete palpation ofthe entire colon during surgery oF intraop- erative colonoscopy might be required. Accepted for Publication: December 1, 2004. Correspondence: Edward Ram, MD, Division of Gen- eral Surgery, Nazereth Hospital, PO Box 11, Nazereth 16100, Israel (eramadan@actcom.netil) —_ EES} Pal, Hall. Whatith oe of mechanil bol apron ings tn lrgig clr surge? 0 Colon Racum 1008: 275-883. 2 Sen Asal Ear, Wetman owl preparation: ‘say elope elon anaetamasie? an examen sy Di Coon Fest, 185 28740-754, 2 IningADSringtour 0. Maan bv papain faroiresecton an astm BS, 18774580 58, 4 Hae IM, lead liam The ett of oval prepara on oan surge. Word Sug 1082675-18, 65 Walt 86 ert RW, Doze Rta. Anew bon preprint Colonna etl surge: aprespeciveranéomeed cna al Ach Su 1988 ‘rea0s.00 6 Bu P Mea Kid, oye W, Tajo O, yan giana forse preparation in caret sua Br. Sur 19948807 910. 7 Mite. Linen ST, Mal, Paloen ME, Baw prepation vith ‘ol petyane ea ecto sciuin sno preparation elec open Color sug: prspecterandonized st. Dis Colm Fectum. 200 iene? (©2003 American Medical Association. AI rights reserved, Downloaded From: http:/jamanetwork.com/ on 09/25/2017ivr, Wane SO, Dan tl Mahan bow papsatn fran telat euge a prspecte, encamind. eugene tl comping Sedum phosphate pene ha/-ased orl lavge slurs. Dis Co lan Ratu 1097 AS5-591 Lteman DA Gham orator soi phosphate pepe ‘an on serum deca in patos wih oral sau caine. Gs Inet ndose 1a 468. Digna Say CE, Steward. stl. Compson can chaning eth din pep or colrascap.Gastoentraloy 1984 3686-960. an else, Fo S-Oon Neath Ll Compson tar lot au ery without mechanical Bows preparation. J Am Co Surg. 2002,19840 i Buck DE Mecha bovel cleansing for suge. Perspect aon Ret Sug, sau rar-e Sth, Conall, Gimor OTs! telling an clone ans- teat sing, Br Sug, 1083 7040.5. rownson Jn No O, 8 Mstanialbowlrparaton fare o- let suger esl of a respecte randomized al Br J Sr. 182; asta 0 21 2, Sanos 0 Bat, Snare MT, Guimaraes AS, eC. respective tame il of mechanical ove peparn in patents undergoing eine Cell super. BrdSg. BBE 6721676, ‘Zara O Mana XB Zk ta. Calon nd ret up wiht me ‘han! bel peparton. Aon Surg. 2008237 962367. igh MR, Ae. lander Wise J. Young, Burdon OV, Compa fen tse syste andl nimi popyemclarcl ugey inet 179:7 804897. Dison A, Mau W, Thon Haas J Crema ofthe run: a ee ‘patience Br Sug 1917808-31 ian He, Map a 6 et Ec of prophase artis on o- loiter, Am J Surg 1976134753, Caner $, Corel CU, Clie ME Sl, lane WA, Anan RP. Hing of Ischemic cln raster oe of ano raparatn. Sore Sasori Fas VW, Tul RB, Gldnith MG, orc raster tect, Colon Rec 1075.1 07-114 Maal, Burk , Hyd Air esactn witout detuconing colo any: questions sey BJ Surg. 100279205307 hae Archives of Surgery wll give priority review and. catly publication to seminal works. This policy will include basi seience advancements in surgery and eiti= cally performed clinical research, (©2003 American Medical Assoc Downloaded From: http:/jamanetwork.com/ on 09/25/2017 om. A rights reserved,