Major Complications of Operative Gynecologic Laparoscopy in Southern Taiwan

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1 Major Complications of Operative Gynecologic Laparoscopy in Southern Taiwan Ming-Ping Wu, M.D., Yue-Shan Lin, M.D., and Cheng-Yang Chou, M.D. Abstract Study Objective. To describe our experience with major complications in gynecologic laparoscopy compared with literature reports. Design. Retrospective study (Canadian Task Force classification II-3). Setting. Two regional teaching hospitals in southern Taiwan. Patients. One thousand five hundred seven women. Intervention. Gynecologic laparoscopy. Measurements and Main Results. The overall number of major complications in 1507 laparoscopies was 24 (1.6%): 6 bladder injuries, 5 bowel injuries, 4 ureteral injuries, 3 cases of delayed vaginal stump bleeding, 2 cases of postoperative ileus, 2 abscesses, 1 vessel injury, and 1 umbilical hernia. Complication rates were analyzed by type of surgery laparoscopic-assisted vaginal hysterectomy (LAVH) versus non-lavh. We correlated clinical outcome with time of recognition and treatment of complications. Our complication rates were similar to those reported in the literature and were not significantly different between LAVH and non-lavh. Conclusion. Early recognition of injuries, preferably intraoperatively, with immediate appropriate treatment is crucial. It is also important to be alert to early manifestations of complications in the postoperative observation period. (J Am Assoc Gynecol Laparosc 8(1):61 67, 2001) Operative laparoscopy is widely accepted as an efficacious technique in the treatment of the reproductive and gynecologic lesions. 1 An increasing tendency is for more complex gynecologic procedures to be performed laparoscopically, which may account for an increased rate of injuries to organs such as urinary bladder, ureter, intestine, and blood vessels. 2 The overall laparoscopic complication rate was reported to be as high as 9.8% (23/234 patients). 3 In a Finnish study 2 major complication rates in gynecologic laparosocopies were 0.4% (130/32,205 patients) among total procedures and 1.26% (118/9337 patients) for operative laparoscopies. In Taiwan, based mainly on data from patients undergoing laparoscopic-assisted vaginal hysterectomy (LAVH) in university hospitals, the major complication rate was 1.7% (12/722 patients). 4 Bladder and ureteral injuries are relatively common in the gynecologic field, especially when LAVH is performed. 4,5 Serious urinary complications were 16/1000 (15/953 patients), 6 8.5/1000 (79/9337 patients), 2 and 8/1000 (6/722 patients). 4 Bowel injury, although not common, is one of the most serious complications when not detected and managed promptly. 7 The reported rates in laparoscopy range from 1.6/1000 (15/9337 patients) 2 to 2.8/1000 (2/722 patients). 4 Such complications occur more frequently in small local hospitals where laparoscopic expertise is not as extensive as in university hospitals. 2 With increasing performance and increasing complexity of From the Institute of Clinical Medicine, Medical College, National Cheng Kung University (Dr. Wu); Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital (Drs. Wu and Lin); and National Cheng Kung University Hospital (Dr. Chou), Tainan, Taiwan. Address reprint requests to Yue-Shan Lin, M.D., Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital, No. 901, Chung Hwa Road, Yung Kang City, Tainan, Taiwan; fax Accepted for publication September 22,

2 Major Complications of Operative Gynecologic Laparoscopy in Southern Taiwan Wu et al attempted cases, evaluation of safety of these procedures is an important and continuing task. This evaluation should be done not only in university hospitals but also in regional and local hospitals. Accordingly, the goal of our study was to document the frequency of complications during gynecologic laparoscopies, based on 1507 operative laparoscopies performed in two regional teaching hospitals in southern Taiwan. Materials and Methods This retrospective study was based on review of medical records. Periods of study were from December 1992 through November 1999 in the Chi Mei Foundation Hospital and from July 1994 through November 1999 in the Tainan Municipal Hospital. These are classified as regional teaching hospitals in southern Taiwan. The main surgeons were qualified as instructors of the Taiwan Association of Obstetric and Gynecologic Endoscopists. All laparoscopic procedures were evaluated starting with surgeons first year as attending physicians. Patients were informed of risks and possible complications of laparoscopic procedures, including conversion to laparotomy. Informed consent was obtained from all patients. Operative Procedure Patients were placed in 30-degree Trendelenburg position, and laparoscopic procedures were performed as described elsewhere. 8 For LAVH, uterine vessels were desiccated with bipolar Kleppinger forceps and cut with scissors at the level of the internal cervix. Anterior and posterior colpotomy was performed with monopolar electrosurgery. 9 For myomectomy, posterior colpotomy was done in the same way to remove specimens. After a specimen was removed, colpotomy was sutured vaginally. Complications and Data Analysis All complications during and after laparoscopy were recorded. Major operative complications were defined as injuries to the bowel, bladder, or ureter; vascular injuries; significant ileus; and bleeding from abdominal wall or intraperitoneally. We used χ2 tests to determine the relationship between nominal variables, with probability below 0.05 considered statistically significant. Results During the study period, 1561 women underwent laparoscopic procedures. Diagnostic laparoscopies for chronic pelvic pain or infertility in 54 women were excluded, leaving 1507 patients (mean age 41.1 yrs, range yrs) undergoing operative gynecologic laparoscopy (Table 1). Miscellaneous procedures were pelvic tumor excision (2), salpingostomy (4), secondlook laparoscopy for ovarian cancer (2), lymphadenectomy (1), appendectomy (1), ovarian drilling for polycystic ovary disease (3), paravaginal repair (3), and drainage of pelvic abscess (4). Some patients had more than one procedure. Eight major complications occurred in 24 women, for an overall major complication rate of 1.6%. Types of injuries, time of recognition, and methods of treatment are summarized in Table 2. Among them, urinary bladder injuries occurred in six women (4.0/1000), all undergoing LAVH for uterine leiomyoma or carcinoma in situ of the cervix. Dense adhesions between urinary bladder and vagina due to previous cesarean section or fibrosis after conization were found. Five injuries were detected intraoperatively and were successfully repaired with 3-0 chromic catgut double-layer sutures laparoscopically. In one case, the injury was recognized by the appearance of bladder mucosa. In two others, injection of methylene blue dye into the urinary bladder was done before starting TABLE 1. Main Procedures in 1507 Operative Gynecologic Laparoscopies Main Procedure Number % LAVH Oophorectomy and/or salpingectomy Ovarian cystectomy LUNA Burch colposuspension Myomectomy Adhesiolysis Ablation of pelvic endometriosis Tubal ligation Uterine suspension Fimbroplasty Other LAVH = laparoscopic-assisted vaginal hysterectomy; LUNA = laparoscopic uterosacral nerve ablation. 62

3 TABLE 2. Injuries, Time of Recognition, and Treatment Injury (no.) Time of Recognition Surgery Performed (no.) Treatment and Outcomes Bladder (6) Intraoperative LAVH (5) Repair at laparoscopy 14 days LAVH (1) Laparotomy repair Ureter (4) Intraoperative, Oophorectomy (1) Insertion of double J or 2, 7 days LAVH (2) ureteral catheter 3 wks LAVH (1) Laparotomy repair Bowel (5) Intraoperative Burch a (1) Repair at laparoscopy 1 2 days Enterolysis (1), oophorectomy (1), Laparotomy repair adhesiolysis (1) 10 days LUNA (1) Transphincteric repair failed, laparotomy with colostomy Ileus (2) Within 24 hrs LAVH b (1) Conservative 2 days Adhesiolysis (1) Conservative Stump or colpotomy 2 days Myomectomy (1) Vaginal resuturing wound bleeding (3) 1 wk LAVH (2) Vaginal resuturing Reopened and drained vaginally Abscess (2) 4 days Salpingectomy (1) Secondary laparoscopic drainage 1 wk LAVH (1) Reopened and drained stump vaginally Vessel injury (1) Intraoperative Oophorectomy (1) Laparotomy repair Umbilical hernia (1) 1 wk Oophorectomy (1) Resuturing a The patient had genuine stress incontinence and vaginal stump prolapse, and underwent laparoscopic Burch colposuspension, enterolysis, and sacropexy. b The patient had uterine prolapse and genuine stress incontinence, and underwent LAVH, modified Halban colpopexy, and Burch colposuspension. laparoscopic procedures due to suspected intraperitoneal adhesions. Spillage of dye was seen, and the cystotomy was repaired. In the other two cases, substantial amount of gas was present in the Foley bag, leading us to suspect injury to the urinary bladder. The diagnosis was confirmed by injection of methylene blue, and the injuries were repaired uneventfully. All five women recovered uneventfully. The only patient with unrecognized bladder injury developed leakage of urine from vagina about 2 weeks after laparoscopy. Vesicovaginal fistula was confirmed by cystography. Laparotomy for fistulectomy was performed without incident. Ureteral injuries occurred in four women (2.7/ 1000). One was detected intraoperatively, and the other three were detected postoperatively on days 2, 7, and 21, respectively. The first three patients were successfully treated with ureteral catheter placement. The fourth had urine leaking into the intraperitoneal cavity 3 weeks after laparoscopy. After failed ureteral catheterization, she underwent laparotomy for end-toend ureteral anastomosis. Bowel injuries occurred in five women (3.3/1000), only one of which was recognized intraoperatively; it was successfully repaired during laparoscopy. Three women experienced symptoms of abdominal distention or peritoneal rebounding pain 1 to 2 days after laparoscopy. Repairs by laparotomy with or without colostomy were performed uneventfully. The fourth patient, a 25-year-old woman with endometriosis, had a bloody stool 10 days after laparoscopic uterosacral nerve ablation. Colonoscopy revealed a rectal ulcer. Transphincteric repair was attempted but failed, and the patient underwent colostomy for definitive treatment. Two women (1.3/1000) experienced postoperative ileus, which improved with conservative treatment. One was a 65-year-old woman undergoing LAVH, Burch colposuspension, and modified Halban colpopexy for uterine prolapse, genuine stress incontinence, 63

4 Major Complications of Operative Gynecologic Laparoscopy in Southern Taiwan Wu et al and enterocele. 8 The other was an 18-year-old girl who underwent adhesiolysis. These two patients were carefully monitored and recovered without surgical intervention. They were discharged to home 10 and 7 days later, respectively, without sequelae. Delayed bleeding from vaginal stump or colpotomy wound occurred in three patients (2.6/1000) and ceased after resuturing or drainage transvaginally. Of two pelvic abscess (1.3/1000); one required secondary laparoscopy for drainage, and the other was treated with vaginal incision and drainage. The only injury to a major vessel (0.7/1000) occurred in a 29-year-old multiparous woman undergoing oophorectomy for ovarian tumor. During introduction of a 10-mm cannula by a resident physician, blood gushed out of the cannula. The abdomen was opened immediately and a laceration of the right common iliac artery was found. The laceration site was immediately repaired by continuous sutures with 6-0 polypropylene. The single umbilical herniation of omentum (1.7/1000) required repair of abdominal fascia. We compared our results with the literature regarding complication rates of laparoscopic surgery (Table 3). 2,11 Our overall major complication rate of 1.6% was comparable with these two studies (p = 0.30 and p = 0.58, χ2 test, respectively). Furthermore, our complication rates were not significantly different from those studies in terms of urinary bladder, ureteral, and bowel injuries (p >0.05, χ2 test). However, our rate of miscellaneous complications was significantly higher than that of the former study (p = 0.01, χ2 test), which may attributed to heterogeneous types of surgery by that group. We also compared complication rates between LAVH and non-lavh to test the effects of surgical complexity on the rate. The rate for LAVH was 1.8%, compared with 1.3% for non-lavh (p = 0.60, χ2 test). The difference in rates between hospitals was compared to determine interpersonal differences. The rate at Chi May Hospital was 1.38% and that at Tainan Municipal Hospital was 2.76% (p = 0.12, χ2 test). Discussion The major complication rate for gynecologic laparoscopies performed in regional teaching hospitals in southern Taiwan compares with those reported in the literature. Specifically, our data are not significantly different from either the study with one of the lowest rates reported (p = 0.297, χ2 test) 2 or the one from the TABLE 3. Major Complications and Comparison with Two Studies This Study First Study 2 Second Study 11 (N = 1507) (N = 9337) (N = 843) Proportion 95% CI Proportion 95% CI Proportion 95% CI Complication No. (/1000) (/1000) No. (/1000) (/1000) p No. (/1000) (/1000) p Bladder injury Ureteral injury Bowel injury Major vessel injury Hernia Others Vaginal stump bleeding Postoperative ileus Pelvic abscess Abdominal bleeding Totals χ 2 test: total complication rate in this study versus the first study, p=0.30; this study versus the second study, p=0.58 (NS). This study versus the first study: not significant in bladder (p=0.25), bowel (p=0.15), and ureteral injuries (p=0.10); significant in others (p=0.01). This study versus the second study: not significant in bladder injuries (p=0.52), bowel injuries (p=0.59), ureteral injuries (p=0.46), and others (p=0.16). 64

5 university hospital in northern Taiwan (p = 0.883, χ2 test). 4 In our series, 54.2% (13/24 patients) of complications occurred in the LAVH group, which reflects the large proportion of LAVH performed. However, the major complication rate was not significantly different between LAVH and non-lavh. According to one report, more complex laparoscopic procedures resulted in proportionately greater rates of operative complications that required postoperative admission to the hospital; however, there were only 40 LAVH operations in that report. 11 In contrast, the complication rate for advanced laparoscopic procedures, including laparoscopic hysterectomies performed by highly experienced physicians was not higher than that for standard operative laparoscopies. 12 It is possible that the surgeon s experience is a significant predictor of complications. In fact, once a surgeon has performed approximately 60 procedures, the frequency of complications plateaus. 13 Urinary bladder injuries were the most common major complication in our series, and occurred in women undergoing LAVH. Owing to the closeness of the uterus to the cervix, and in women with a history of cesarean sections, urinary bladder injury is one of the most common complications in LAVH. Fortunately, all bladder injuries but one were recognized intraoperatively and repaired laparoscopically. When these injuries occur, early recognition with immediate repair enables them to be managed easily. 6 It was suggested the vesicocervical space can be recognized by fluid remaining in the urinary bladder while pushing the urinary bladder away from the vagina. 1 Our present report further indicates that maneuvers such as instilling dye into the urinary bladder or observing gas leakage into the Foley bag preoperatively or intraoperatively in patients at high risk for organ injury can aid in recognizing these injuries. Three patients in whom ureteral injuries were detected intraoperatively or shortly after surgery were treated successfully by conservative management such as ureteral catheterization. In contrast, delayed detection in one woman required end-to-end ureteral anastomosis. Together with cases of bladder injuries, this emphasizes the importance of early recognition of injuries, followed by immediate treatment to reduce surgical morbidity. Ureteral injuries secondary to operative laparoscopy usually are not recognized during the intervention. The diagnosis is usually made radiologically in the postoperative period, when the patient has signs and symptoms (persistent abdominal and/or flank pain, abdominal distention, fever) suggestive of the injury. When recognized, prompt repair is suggested, instead of delaying repair with the aim of increasing the viability of the ischemic segment of ureter. 14 Most patients required laparotomy. Rarely, the injury is recognized and repaired by laparoscopic suture techniques intraoperatively. 15 The proximity of ureters to uterosacral ligaments must be considered when operating in this region. A high index of suspicion and visualization or retroperitoneal dissection of the ureter during the same procedure will help. 15 It was suggested that preoperative intravenous pyelogram may be performed in patients whose uterine size is 12 weeks or larger, or in whom an adnexal mass is 4 cm or larger. 16 To increase the safety of desiccation of uterine arteries by bipolar electrosurgery during LAVH, we developed a technique for hemostasis. Polydioxanone clips were placed at the uterine arteries located between the ureter and bifurcation of the hypogastric artery before uterine vessels were desiccated. 9 This prevents excessive bleeding from uterine vessels and thermal injury of ureters. Most electrical injuries are unrecognized when they occur, which may lead to long-term sequelae. The small bowel, especially the ileum, is most frequently involved, and the injury may not cause clear or rapid symptoms and abnormal laboratory values. 16 Reports of intestinal injuries described different clinical symptoms and histologic findings between electrothermal and traumatic injury. 17,18 Symptoms of bowel perforation after electrical injury usually arise 4 to 10 days after the procedures, whereas symptoms of traumatic perforation usually occur within 12 to 36 hours. 18,19 The degree of peritonitis depends on the amount of spillage and length of time between perforation and exploration. 4 Enterolysis and pelvic adhesiolysis have more risks associated with immediate bowel perforation and injury to the bowel wall that results in delayed perforation and peritonitis. Although repair by laparotomy may be the safest way to manage these injuries, single- or double-layer repairs that can be done by laparoscopic-assisted transvaginal approach or total laparoscopic intracorporeal technique followed by copious irrigation might be also satisfactory. 20 Postoperative intestinal obstruction occurred in two women. It is possible that Halban colpopexy as an adjuvant procedure precipitated the risk of this complication due to placement purse-string sutures involving serosa of colon. It is advised that 65

6 Major Complications of Operative Gynecologic Laparoscopy in Southern Taiwan Wu et al inappropriate use of electrosurgical instruments and pneumoperitoneum may impair bowel movement and result in intestinal obstruction. In such cases careful observation without surgical intervention is usually sufficient. 4 During the observation period, which may last 3 to 5 days, the laparoscopist should be alerted to early manifestations of peritonitis. Exploratory laparotomy is indicated for patients with persistent symptoms on the third or fourth postoperative day. Delayed bleeding of vaginal stump or colpotomy wound may be due to occlusion by pressure of pneumoperitoneum and steep Trendelenburg position. Underwater inspection with Ringer s lactate solution was proposed. 21 Pelvic abscess in our series may have been due to incomplete irrigation of preexisting infectious microorganisms in the pyosalpinx or subclinical pelvic inflammation. Major vessel injury may have resulted from inadequate pneumoperitoneum and/or mishandling of the cannula. In addition to terminal aorta, vena cava, iliac arteries, and veins, any intraperitoneal organ and associated vessels may be traumatized by laparoscopic manipulation. 4,22 Significant hypotension, tachycardia, and pooling of blood in the upper abdomen are signs of vascular injury. Full pneumoperitoneum, a functional safety shield, and skilled surgeons may limit the risk of major vascular injuries. 23 The occurrence of incisional hernia may not be related to the length of the surgeon s career, but relates significantly to the number of laparoscopies performed per year. 24 Hernias are most likely to occur through 10-mm or larger ports at both umbilical and extraumbilical sites. 25 Conclusion Complication rates in two regional hospitals in southern Taiwan were similar to those in the literature and were not significantly different between LAVH and non-lavh. Early recognition of injuries, preferably intraoperatively with the aid of preventive maneuvers, followed by immediate treatments is crucial to reduce catastrophic consequences. 26 It is important to be alert to the early manifestations of complications for several days after surgery. References 1. Lee CL, Lai YM, Soong YK: Management of urinary bladder injuries in laparoscopic assisted vaginal hysterectomy. Acta Obstet Gynecol Scand 75: , Harkki-Siren P, Sjoberg J, Kurki T: Major complications of laparoscopy: A follow-up Finnish study. Obstet Gynecol 94:94 98, Quasarano RT, Kashef M, Sherman SJ, et al: Complications of gynecologic laparoscopy. J Am Assoc Gynecol Laparosc 6(3): , Lee CL, Lai YM, Soong YK: Management of major complications in laparoscopically assisted vaginal hysterectomy. J Formosa Med Assoc 97(2): , Meikle SF, Nugent EW, Orleans M: Complications and recovery from laparoscopy-assisted vaginal hysterectomy with abdominal and vaginal hysterectomy. Obstet Gynecol 89: , Saide MH, Sadler RK, Vancaillie TG: Diagnosis and management of serious urinary complications after major operative laparoscopy. Obstet Gynecol 87: , Peterson HB, Ory HW, Greenspan JR, et al: Deaths associated with laparoscopic sterilization by unipolar electrocoagulating devices, 1978 and Am J Obstet Gynecol 139: , Wu MP: Laparoscopic modified Halban colpopexy associated with LAVH in treating uterine prolapse. J Gynecol Surg 13: , Lin YS, Chou CY: A modified procedure of laparoscopic hysterectomy: Preligating the uterine arteries with polydioxanone clips. J Gynecol Surg 12: , Wu MP: Laparoscopic uterine suspension for the treatment of uterovaginal prolapse. Int J Gynecol Obstet 59: , Mirhashemi R, Harlow BL, Ginsburg ES, et al: Predicting risk of complications with gynecologic laparoscopic surgery. Obstet Gynecol 92: , Querleu D, Chapron C: Complications of gynecologic laparoscopic surgery. Curr Opin Obstet Gynecol 7: , Tucker RD: Laparoscopic electrosurgical injuries: Survey results and their implications. Surg Laparosc Endosc 5(4): , Wang AC: Urinary bladder injuries in obstetric and gynecologic procedures. J Gynecol Surg 13:69 75, Gomel V, James C: Intraoperative management of ureteral injury during operative laparoscopy. Fertil Steril 55(2): ,

7 16. Piscitelli JT, Simel DL, Addison A: Who should have intravenous pyelograms before hysterectomy for benign disease? Obstet Gynecol 69: , Soderstrom RM: Bowel injury litigation after laparoscopy. J Am Assoc Gynecol Laparosc 1(1):74 77, Levy BS, Soderstrom RM, Dail DH: Bowel injuries during laparoscopy: Gross anatomy and histology. J Reprod Med 30(3): , Reich H: Laparoscopic bowel injury. Surg Laparosc Endosc 2(1):74 78, Reich H, McGlynn F, Budin R: Laparoscopic repair of full-thickness bowel injury. J Laparoendosc Surg 1: , Levy BS: Complications of laparoscopic surgery. In The Video Encyclopedia of Endoscopic Surgery for the Gynecologist. Edited by GJ Shirk. St. Louis, Medical Video Productions, 1994, pp Nordestgaard AG, Bodily KC, Osgorne RW, et al: Major vascular injuries during laparoscopic procedures. Am J Surg 169: , Chandler JG, Voyles CR, Floore TL, et al: Litigious consequences of open and laparoscopic biliary surgical mishaps. J Gastrointest Surg 1(2): , Monz FJ, Holschneider CH, Munro MG: Incisional hernia following laparoscopy: A survey of the American Association of Gynecologic Laparoscopists. Obstet Gynecol 84: , Boike GM, Miller CE, Spirtos NM, et al: Incisional bowel herniations after operative laparoscopy: A series of nineteen cases and reviews of the literature. Am J Obstet Gynecol 173: , Wu MP, Ou CS, Chen SL, et al: Electrosurgical safety in laparoscopy: Biophysics, mechanisms, and recommended practices. Am J Surg 179:67 73;