Mechanical bowel preparation before gynecologic laparoscopy: a randomized, single-blind, controlled trial

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1 REPRODUCTIVE SURGERY Mechanical bowel preparation before gynecologic laparoscopy: a randomized, single-blind, controlled trial Ludovico Muzii, M.D., a Filippo Bellati, M.D., b Marzio Angelo Zullo, M.D., a Natalina Manci, M.D., b Roberto Angioli, M.D., a and Pierluigi Benedetti Panici, M.D. b a Department of Obstetrics and Gynecology, Campus Bio Medico University of Rome; and b Department of Gynecology and Obstetrics, University of Rome La Sapienza, Rome, Italy Objective: To evaluate the use of mechanical bowel preparation () before gynecologic laparoscopy, using as the primary endpoint the appropriateness of the surgical field as judged by the surgeon. Design: Prospective, randomized, single-blind clinical trial. Setting: Academic department specializing in gynecologic surgery. Patient(s): One-hundred sixty-two patients scheduled for laparoscopy. Intervention(s): The evening before laparoscopy, patients were randomized to either with 90 ml of oral sodium phosphate (NaP) or no bowel preparation. Main Outcome Measure(s): Patient discomfort was evaluated with a visual analogue scale. Bowel preparation was evaluated by a surgeon (blind to bowel-preparation status) using a 5-point scale. Surgical difficulty, operating times, and postoperative complications were recorded. Result(s): Preoperative discomfort was significantly greater in the group. No significant difference in the evaluation of the surgical field, operative difficulty, operative time, and postoperative complications was present between the two groups. Conclusion(s): Bowel preparation with oral NaP does not offer any significant advantage in patients undergoing laparoscopy for benign gynecologic conditions. In addition, significantly increases preoperative discomfort. (Fertil Steril 2006;85: by American Society for Reproductive Medicine.) Key Words: Mechanical bowel preparation, gynecology, laparoscopy Received March 17, 2005; revised and accepted August 31, Reprint requests: Ludovico Muzii, M.D., Campus Bio Medico University of Rome, Department of Obstetrics and Gynecology, Via Longoni 83, Rome 00155, Italy (FAX: ; l.muzii@unicampus.it). Mechanical bowel preparation () with hyperosmotic laxatives is routinely used by many surgeons before gynecologic procedures, both for benign and malignant conditions. The rationale for the use of is to decrease peritoneal contamination in case of bowel injury and to empty the bowel of its contents to improve the surgical field and handling of the bowel itself (1). Bowel complications with unexpected bowel opening, although relatively rare during benign gynecologic surgery (2 4), nonetheless represent one of the reasons behind routine administration of. In gynecology, improved field visualization and bowel handling is probably the most important issue: because of the small size of the pelvis and its relatively unexpandable boundaries composed mostly of bones, surgical field has always been perceived as a major problem. The belief that the bowel must be emptied before surgery would seem to be true especially for gynecologic laparoscopy. During this procedure, the bowel competes with the insufflated CO 2 for the same intra-abdominal space, and an empty bowel would be expected to be more easily handled compared with a bowel that contains a gross fecal load (1). Recently, the necessity of routine use of has been questioned in several surgical specialties, including urologic (5) and colorectal surgery (6), but to date no trial has been conducted in gynecologic surgery. The objective of the present trial was to evaluate the role of in laparoscopic benign gynecologic surgery. The primary endpoint of this trial was the effect of bowel preparation on the surgical field. Secondary endpoints were operative time, intraoperative and postoperative complications, postoperative stay, and patient discomfort. MATERIALS AND METHODS This prospective, randomized, single-blind clinical trial was conducted in an academic department specializing in gynecologic surgery. All surgical procedures were carried out by senior surgeons. Institutional review board approval was obtained. Participants were given oral and written informa /06/$32.00 Fertility and Sterility Vol. 85, No. 3, March 2006 doi: /j.fertnstert Copyright 2006 American Society for Reproductive Medicine, Published by Elsevier Inc. 689

2 tion, and each signed a consent form. All data collection was performed within the department. Eligible patients were women scheduled to undergo diagnostic or operative laparoscopy. To achieve a homogeneous sample of patients, women with high-risk factors for adhesions and/or obesity were excluded. Eligibility criteria were age years, no clinically significant present or past (not under chronic pharmacologic treatment) systemic disease, body mass index of kg/m 2, and no history of previous abdominal surgery. Preoperatively, all candidates were subjected to a detailed general and gynecologic history, complete physical examination, urine pregnancy test, and transvaginal ultrasonography. Exclusion criteria were previous abdominal surgery, suspicion of malignancy, necessity to perform associated nongynecologic procedures, and hysterectomy. The night before surgery, patients were randomized to either bowel preparation with 90 ml of oral sodium phosphate (NaP) or no preparation. Randomization assignment according to a computer-generated sequence was performed in the ward with sealed, opaque envelopes. The next morning patients were asked to evaluate with a visual analogue scale (VAS) the intensity of different symptoms (insomnia, weakness, abdominal distention, nausea, thirst) with standardized questions. Patients in the bowel preparation group were asked an additional question regarding the difficulty in drinking the solution. Finally, patients were asked to give a VAS score for the overall discomfort experienced during the preceding night. After induction of general anesthesia, a 10-mm laparoscope was introduced through the umbilicus, whereas one to three accessory 5-mm trocars were used for the introduction of ancillary instruments. Diagnostic laparoscopy was performed, and the surgeon was asked to evaluate the degree of the small and large bowel preparation and the overall appropriateness of the surgical field. A 5-point scale (poor, sufficient, medium, good, excellent) was used for this evaluation (7). At the end of surgery, the surgeon expressed an evaluation of surgical difficulty using a VAS scale. Operative time and intraoperative and postoperative complications were recorded. Twenty-four hours postoperatively, the patient was asked to evaluate with a VAS scale the degree of nausea, pain, and abdominal swelling. The duration of postoperative ileus (evaluated by first passage of flatus) and postoperative stay were recorded. The sample used (70 vs. 70 observations) was selected to detect, with 80% power at the.05 level, a difference of 20% in the outcome measure, given a reference rate of 87% for appropriately prepared bowel as reported by Oliviera et al. (7). Parametric tests were used after evaluation of the normal distribution of the data to be analyzed. Student s t-test was used for continuous parametric variables, and the 2 test was used for categorical variables. The Mann-Whitney test was used for nonparametric data. Statistical significance was set at a P value of.05. RESULTS From January 1999 to March 2002, 267 patients were evaluated for enrollment in this trial; 162 patients entered the trial, with 81 enrolled in each arm. After diagnostic laparoscopy, 22 randomized patients (12 and 10 patients from the bowel preparation and the control arm, respectively) were converted to laparotomy. In the arm, 6 patients were FIGURE 1 Flow diagram of the phases of the trial. 690 Muzii et al. Bowel preparation before laparoscopy Vol. 85, No. 3, March 2006

3 TABLE 1 Patients characteristics and surgical procedures carried out. Parameter (n 81) No (n 81) P Patients characteristics Median age (range) (y) 32 (18 65) 34 (18 65) Mean body mass index ( SD) (kg/m 2 ) Surgical procedure carried out with laparoscopy (n) Ovarian cystectomy Diagnostic procedure/minor adhesiolysis Adnexectomy 8 12 Myomectomy 0 2 Surgical procedure carried out with minilaparotomy (n) Myomectomy 6 4 Hysterectomy 6 6 Note: nonsignificant. subjected to hysterectomy, and 6 patients were subjected to multiple myomectomy with minilaparotomy. In the control arm, 6 patients were subjected to hysterectomy and 4 were subjected to multiple myomectomy with minilaparotomy. In no case was conversion from laparoscopy to laparotomy because of surgical complications necessary. All patients who were subjected to laparotomy were affected by myomas. The flow of participants is shown in Figure 1. FIGURE 2 Preoperative side effects reported with a VAS. All symptoms were significantly more severe in patients subjected to. Fertility and Sterility 691

4 TABLE 2 Surgeon evaluation of the surgical field. Surgical field evaluation (n 81) No (n 81) P Overall evaluation Poor 9 11 Sufficient Medium Good Excellent 2 5 Small bowel evaluation Poor Sufficient Medium Good Excellent 4 6 Large bowel evaluation Poor Sufficient Medium Good Excellent 2 4 Patients characteristics are reported in Table 1. Briefly, the mean ( SD) age was years, and mean body mass index was kg/m 2. Adnexal fluid cysts were the most frequent indication (60%), followed by myomas (12%). Less frequently encountered indications were infertility and endometriosis. Patient discomfort due to was significant. All preoperative symptoms investigated were significantly more severe in the bowel preparation group. In particular, the difference in VAS scores for insomnia, weakness, abdominal distension, hunger/thirst, and nausea/vomiting were all highly significant (Fig. 2). Evaluation of the small and large intestine preparation by the operating surgeon was not significantly different between the two groups (Table 2). The overall evaluation of the surgical field was graded as good or excellent in 22% of the patients in the group and 30% in the control group (P not significant). Surgical difficulty was similar in the two groups ( and for the and control group, respectively). Surgical time was also similar in the two groups (47 25 minutes and minutes for the and control group, respectively). Postoperatively, no difference was found between the two groups. Postoperative nausea was equally present in both groups, and postoperative pain and abdominal swelling were equally intense. No difference in duration of postoperative ileus or postoperative stay was identified (Table 3). DISCUSSION Since the introduction of evidence-based medicine in routine clinical practice, several traditional dicta have been abandoned in gynecology in favor of more validated clinical behaviors (8 10). Mechanical bowel preparation has traditionally been used to obtain two main goals: removal of bulky intraluminal contents to improve surgical field visualization and handling of the bowel; and decrease of peritoneal and wound contamination by intraluminal content in case of bowel opening (1). Regarding reduction in contamination in the case of bowel injury, data can be extrapolated from colorectal surgery. Several randomized controlled trials have failed to identify a benefit of before elective colorectal surgery (1, 5 7, 11 13). In addition, a recent meta-analysis (6) of 1,454 patients enrolled in seven randomized trials has disputed the belief that reduces the risk of anastomotic leakage and other septic and nonseptic complications. Compared with the no-preparation regimen, significantly more anastomotic leakage occurred after (5.6% vs. 3.2%; odds ratio 1.75, 95% confidence interval , P.032). In addition, infections and other septic and nonseptic complications were more common in patients subjected to, although in a nonsignificant way. These data suggest that might actually be detrimental. TABLE 3 Postoperative data: patients subjected to diagnostic or operative laparoscopy. Side effect (n 69) No (n 71) P Postoperative pain (VAS scale) (mean SD) Presence of nausea/vomiting, n (%) 12 (17) 11 (15) Abdominal swelling (VAS scale) (mean SD) Median postoperative ileus (range) (days) 1 (1 2) 1 (1 2) Median postoperative stay (range) (days) 1 (1 3) 1 (1 3) 692 Muzii et al. Bowel preparation before laparoscopy Vol. 85, No. 3, March 2006

5 As for improvement of the surgical field and handling of the bowel, could theoretically offer a benefit, especially in gynecologic laparoscopic surgery. In these cases, the pelvis represents the only available space in which the surgeon can work. Furthermore, the bowel can only be handled with blunt instruments, and a decrease in visibility might oblige the surgeon to increase the number of maneuvers, thereby possibly increasing surgical time and incidence of surgical complications. In the present series, however, seems to offer no advantage as to appropriateness of the surgical field and handling of the bowel with laparoscopic instruments. Consistently, operating times, complications, and subjective evaluation of the difficulty of the procedure as judged by the surgeon were comparable in patients who received and patients who did not. These data support the idea that before laparoscopy does not make surgery easier. In the present trial, NaP was used because it has been demonstrated by several randomized controlled trials to achieve similar bowel-cleansing results with fewer side effects when compared with polyethylene glycol (7, 14 17). However, in the present trial, patients suffered significant discomfort from. These side effects did not endure postoperatively. The most commonly experienced discomforts were insomnia and abdominal distension, although that which seemed mostly to be due to was nausea/ vomiting. Nosignificant difference in terms of postoperative discomfort and postoperative stay was present. Finally, no severe postoperative complications occurred in either of the two groups. The primary endpoint of the present trial was surgical field improvement, for which a formal sample size calculation was performed. The issue of complications, and in particular bowel complications, was not intended as a primary endpoint. A randomized trial addressing the issue of bowel complications would require a much larger sample size, owing to the relatively low incidence of bowel complications after laparoscopy for benign conditions (2 4). In conclusion, with NaP has demonstrated no influence on the surgical field, surgical difficulty, or on surgical times. In addition, significantly increased patient discomfort reported during the preoperative night. Although is used by the majority of surgeons, its routine use should be abandoned. REFERENCES 1. Muzii L, Angioli R, Zullo MA, Calcagno M, Panici PB. Bowel preparation for gynecological surgery. Crit Rev Oncol Hematol 2003;48: Makinen J, Johansson J, Tomas C, Tomas E, Heinonen PK, Laatikainen T, et al. Morbidity of hysterectomies by type of approach. Hum Reprod 2001;16: van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg 2004;91: Brosens I, Gordon A, Campo R, Gordts S. Bowel injury in gynecologic laparoscopy. J Am Assoc Gynecol Laparosc 2003;10: Shafii M, Murphy DM, Donovan MG, Hickey DP. Is mechanical bowel preparation necessary in patients undergoing cystectomy and urinary diversion? BJU Int 2002;89: Slim K, Vicaut E, Panis Y, Chipponi J. Meta-analysis of randomized clinical trials of colorectal surgery with or without mechanical bowel preparation. Br J Surg 2004;91: Oliveira L, Wexner SD, Daniel N, DeMarta D, Weiss EG, Nogueras JJ, et al. Mechanical bowel preparation for elective colorectal surgery. A prospective, randomized, surgeon-blinded trial comparing sodium phosphate and polyethylene glycol-based oral lavage solutions. Dis Colon Rectum 1997;40: Cutillo G, Maneschi F, Franchi M, Giannice R, Scambia G, Benedetti- Panici P. Early feeding compared with nasogastric decompression after major oncologic gynecologic surgery: a randomized study. Obstet Gynecol 1999;93: Benedetti-Panici P, Maneschi F, Cutillo G, D Andrea G, di Palumbo VS, Conte M, et al. A randomized study comparing retroperitoneal drainage with no drainage after lymphadenectomy in gynecologic malignancies. Gynecol Oncol 1997;65: Gupta JK, Dinas K, Khan KS. To peritonealize or not to peritonealize? A randomized trial at abdominal hysterectomy. Am J Obstet Gynecol 1998;178: Miettinen RP, Laitinen ST, Makela JT, Paakkonen ME. Bowel preparation with oral polyethylene glycol electrolyte solution vs. no preparation in elective open colorectal surgery: prospective, randomized study. Dis Colon Rectum 2000;43: Santos JC Jr, Batista J, Sirimarco MT, Guimaraes AS, Levy CE. Prospective randomized trial of mechanical bowel preparation in patients undergoing elective colorectal surgery. Br J Surg 1994;81: Zmora O, Mahajna A, Bar-Zakai B, Rosin D, Hershko D, Shabtai M, et al. Colon and rectal surgery without mechanical bowel preparation: a randomized prospective trial. Ann Surg 2003;237: Golub RW, Kerner BA, Wise WE Jr, Meesig DM, Hartmann RF, Khanduja KS, et al. Colonoscopic bowel preparations, which one? A blinded, prospective, randomized trial. Dis Colon Rectum 1995;38: Gremse DA, Sacks AI, Raines S. Comparison of oral sodium phosphate to polyethylene glycol-based solution for bowel preparation for colonoscopy in children. J Pediatr Gastroenterol Nutr 1996;23: Curran MP, Plosker GL. Oral sodium phosphate solution: a review of its use as a colorectal cleanser. Drugs 2004;64: Lapalus MG, Gaudin JL, Lemkecher T, Souquet JC, Wendehenne F, Peltrault C, et al. Prospective randomized single-blind trial comparing oral sodium phosphate with polyethylene glycol for colonoscopy preparation. Gastroenterol Clin Biol 2001;25: Fertility and Sterility 693