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Prospective Trial of Gasless Laparoscopic Burch Colposuspension Using Conventional Surgical Instruments
May 2004, Vol. 11, No. 2
The Journal of the American Association of Gynecologic Laparoscopists
Prospective Trial of Gasless Laparoscopic Burch Colposuspension Using Conventional Surgical Instruments G. Willy Davila, M.D., Edward Stanford, M.D., and Abner Korn, M.D.
Abstract
(J Am Assoc Gynecol Laparosc 2004, 11(2):197–203)
Study Objective. To prospectively evaluate the use of gasless laparoscopy techniques in the performance of a traditional Burch colposuspension in women with urodynamically-demonstrated genuine stress incontinence and urethral hypermobility. Design. Multicenter, prospective, single-intervention series (Canadian Task Force Classification II-2). Setting. Three urogynecologic referral centers. Patients. Fifty-eight women. Intervention. Traditional Burch colposuspension performed utilizing gasless laparoscopic access and conventional surgical instruments. Measurements and Main Results. Follow-up was 12 to 38 months. On pad testing, urine loss was significantly reduced, from 6.0 g (CI: 0.55–11.45) to 0.3 g (CI: 0–1.53). Average daily incontinence episodes based on 7-day voiding diaries decreased from 4.7 (CI: 0.87–8.53) to 0.3 (CI: 0–1.58). Q-tip angles were normalized: 49.8 degrees (CI: 40.86–58.74) to 10 degrees (CI: 1.49–18.51). Ninety-five percent of subjects reported resolution of stress incontinence. Three subjects (5%) reported recurrent/persistent genuine stress incontinence: one was operated on during the postpartum period while breastfeeding, and two developed intrinsic sphincteric deficiency postoperatively. Fifty-five percent of subjects underwent other pelvic reconstructive surgery including posterior wall repairs. Average operative time was 60.8 minutes (range, 40–92). The ideal candidate has an unscarred abdominal wall. Conclusion. Gasless laparoscopic access was used to effectively perform traditional Burch colposuspension using conventional open surgical instruments. Bladder neck hypermobility was normalized in all subjects, and 95% of subjects reported no further stress incontinence.
ing utilizing surgical staples and synthetic mesh.5,6 These laparoscopic approaches have been popularized, although long-term outcome data are not available, and should not be equated to that of traditional Burch procedures. Using conventional surgical instruments may help reduce the learning curve for performance of a laparoscopic Burch procedure. The purpose of this prospective study was to evaluate the performance of a traditional Burch procedure, with the same suture materials and suturing techniques, using gasless laparoscopic equipment. Gasless laparoscopy allows for use of routine open operating instruments, sutures, and needles, thus simplifying the actual surgical approach.
Surgical approaches to stress incontinence have been based on reducing bladder neck mobility by suspension of para-urethral fascia to a strong pelvic or abdominal structure. Outcome studies have identified the Burch colposuspension as the technique with the best long-term success rates.1,2 Since this procedure traditionally requires a laparotomy incision, there have been multiple reported attempts at performing the same procedure laparoscopically. Using gas laparoscopy and laparoscopic instruments, Burch procedures have been reported with satisfactory objective short-term results.3 A prospective study comparing open to laparoscopic procedures demonstrated similar short-term success rates.4 Performance of laparoscopic Burch procedures using the same suturing techniques and placement as during an open procedure has challenged even the best gynecologic surgeon. Alternative laparoscopic approaches to bladder neck suspension procedures have been developed, includ-
Materials and Methods Women with stress urinary incontinence with associated urethral hypermobility who were candidates for traditional Burch colposuspensions were offered enrollment
From the Cleveland Clinic Florida, Weston, Florida (Dr. Davila); St. Mary’s/Good Samaritan, Centralia/Mt. Vernon, Illinois (Dr. Stanford); and the University of California, San Francisco, California (Dr. Korn). Corresponding author G. Willy Davila, M.D., Cleveland Clinic Florida, 2950 Cleveland Clinic Boulevard, Weston, FL 33331. Supported in part by Origin Medsystems, Menlo Park, California. Submitted June 18, 2003. Accepted for publication January 7, 2004. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, May 2004, Vol. 11 No. 2 © 2004 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.
197
Gasless Laparoscopic Burch Colposuspension Davila et al
at three urogynecologic clinical centers. This study received approval by the institutional review board at each institution, and all subjects signed an informed consent document. All terminology used was in accordance with International Continence Society standards except where noted. Before enrollment, subjects underwent full urogynecologic evaluation in order to diagnose genuine stress incontinence and document urethral hypermobility. The evaluation consisted of a complete history and physical examination including a pelvic examination to assess pelvic supports. Urethral mobility was evaluated with a cotton swab stress test. Laboratory testing included a urinalysis and pregnancy test for women of childbearing potential. Multichannel urodynamic evaluation included uroflowmetry, resting-empty and full-bladder urethral pressure profilometry, medium fill subtracted water cystometry, and stress cough urethral pressure profilometry. Catheterized postvoid residual urine was measured to rule out urinary retention. Cystometry was performed using room temperature sterile water at a fill rate of 80 mL/min with the subjects standing and performing multiple provocative maneuvers. Urethral pressure profiles (UPP) were performed with the patient supine and a double transducer microtip catheter withdrawn by a puller arm. A cough urethral profile pressure transmission ratio was calculated as an average of the cough-induced pressure changes in the proximal half of the urethra. Cystourethroscopy was performed in order to identify any abnormality of lower urinary tract anatomy and evaluate bladder neck mobility. Following urodynamic testing, all subjects received antibiotic prophylaxis for 24–48 hours. For enrollment, subjects
had to be symptomatic of stress incontinence and have a urodynamic diagnosis of genuine stress incontinence with urethral hypermobility. Patients with maximum UPP <20 cm H2O were excluded. We chose not to enroll patients with previous bladder neck suspensions due to the likelihood of significant retropubic scarring. Incontinence severity was assessed utilizing a standardized pad test and a 7-day bladder diary. This assessment was performed preoperatively as well as at 12-weeks and 1-year postoperatively. Outcome measures included changes in severity parameters as well as changes in Q-tip angle from the preoperative measured angle. Surgical Technique The operation is performed with the patient in low lithotomy position. A Foley catheter is placed for bladder drainage. The Laparolift gasless laparoscopy system (Origin Medsystems, Menlo Park, California) was used for all the surgical procedures. This system uses a mechanical lifter to elevate the anterior abdominal wall. The lifting arm is attached to the operating table at the level of the patient’s right shoulder, with the abdominal wall being elevated at the level of the umbilicus (Figure 1). For this series, a preperitoneal approach was used. A small subumbilical incision is made, and the dissecting balloon is placed subfascially in the preperitoneal space. The balloon is advanced to the level of the pubic bone, and the balloon is filled using a manual pump, with simultaneous laparoscopic visualization from within the balloon. Once the balloon is fully distended and the space of Retzius is satisfactorily dissected open (Figure 2), the balloon is deflated and removed. A fan-shaped attachment is placed such that the arms are
FIGURE 1. The Laparolift mechanical arm in position for gasless laparoscopic surgery.
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The Journal of the American Association of Gynecologic Laparoscopists
A
B
Figure 2. Laparoscopic view of the space of Retzius through the dissecting balloon with ample expansion of the operative field. (A) Lateral view with balloon in place. (B) View of dissected retropubic space through laparoscope.
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Gasless Laparoscopic Burch Colposuspension Davila et al
Results Fifty-eight women were enrolled and underwent the laparoscopic Burch colposuspensions, with follow-up visits at 12–38 months. Average age was 49 years (range 30–80). Preoperative pad testing showed an average urine loss of 6.0 g (CI: 0.55–11.45). This decreased to 0.3 g (CI: 0–1.53) postoperatively (p < .05). Average daily incontinence episodes decreased from 4.7 (CI: 0.87–8.53) preoperatively to 0.3 (CI: 0–1.58) postoperatively (p < .05). Additionally, Q-tip angles were normalized (normal = <30 degrees from horizontal plane), decreasing from 49.8 degrees (CI: 40.86–58.74) preoperatively to 10 degrees (CI: 1.49–18.51) postoperatively (p < .05). Three (5%) subjects reported recurrent stress incontinence during follow-up. One had undergone surgery during the postpartum period while breastfeeding. Her vaginal mucosa was markedly atrophic, and it was thought that her endopelvic fascia was likely still weak from her pregnancy and lactational hypoestrogenism. The remaining two women were noted to have intrinsic sphincteric deficiency on postoperative urodynamics. Both had negative Q-tip angles and underwent collagen injections with a successful outcome. Fifty-five percent of the women underwent other pelvic reconstructive procedures including posterior wall repairs. Operative time for the laparoscopic procedure averaged 60.8 minutes (range, 40–92) from umbilical incision to closure of all incisions. No bladder or ureteral trauma was noted. No infectious complications were noted. Estimated blood loss in all cases was less than 400 mL for the laparoscopic Burch, and no transfusions were required.
located under the belly of each rectus muscle, directed toward each inguinal area. The fan is then attached to the Laparolift, and the preperitoneal abdominal wall is elevated. A zero degree laparoscope is then inserted immediately below the fan, allowing visualization of the operating field. Two 2-cm operating instrument access ports are then sharply created, approximately 3 cm above each Cooper’s ligament. These ports are kept open by using a small Deaver or “S” retractor. No trocars are necessary as the operating space does not require a pneumatic seal. Standard operating instruments are then inserted through the operating ports (Figure 3). Sponge sticks can be placed to aid in dissection of the bladder and connective tissue off of the peri-urethral fascia for placement of the suspensory sutures. If bleeding occurs at anytime during the operation, a standard wall suction cannula or hand-held electrocautery unit can be used. Once the bladder has been satisfactorily mobilized, a standard needle driver and suture can be inserted. For this series, we used CV-2 Gore-Tex sutures on THX-26 or THX-25 needles—standard suture and needles that are used for open Burch procedures. Two figure-of-eight sutures were placed on either side of the urethra, at 2- and 4-cm lateral to the urethrovesical junction (Figure 4). They were then passed through the ipsilateral Cooper’s ligament, in a manner analogous to the open procedure. Cystoscopy was performed to confirm bladder integrity and ureteral function. The knots are then tied digitally (i.e., without a knot pusher) to normalize bladder neck support (Figure 5). The skin incisions were closed. Additional pelvic procedures were then performed as required for each individual patient.
FIGURE 3. Conventional open operating instruments.
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FIGURE 4. Two stitches bilaterally in completed gasless Burch procedure.
FIGURE 5. Knots being pushed digitally.
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Discussion Gasless laparoscopy allows for the usage of conventional open surgery instruments in the performance of laparoscopic surgery, making it unnecessary to modify suture placement techniques. In this series, a traditional Burch colposuspension was performed using laparoscopic access. Suture type and placement was identical to that used during an open procedure. According to our short-term efficacy evaluation of this procedure, the success appears to be equivalent to that of the open procedure. Two subjects were noted to have de novo intrinsic sphincteric deficiency (maximal urethral closure pressure <20 cm water) as a cause of their surgical failure. This is likely not technique-dependent, as this can occur following open Burch procedures performed with similar suture placement. Significant advantages of this procedure include the usage of instruments with which the surgeon is likely to be familiar, ability to obtain tissue bites of similar thickness to the open procedure, and ability to tie knots digitally rather than using a knot pusher. Thus, some commonly encountered problems of laparoscopic surgery, such as long and cumbersome instruments and suboptimal tissue bites, are avoided. Previous reviews have suggested that laparoscopic Burch procedures may be associated with a poorer outcome than open procedures.7 Utilizing instruments and technique traditionally used for open procedures may thus improve laparoscopic Burch success rates. Many modifications of the traditional Burch procedure have been reported. The challenges of laparoscopic surgery have led to further procedural modifications that may affect long-term outcomes. Single bilateral tissue bites, usage of staples and mesh, and usage of sutures of lesser thickness have been reported for laparoscopic “Burch” procedures.5,6,8–10 Unless the procedure is performed as described for the open technique, it cannot be called a “Burch” procedure, and similar outcomes may not be realistic. Experienced laparoscopic surgeons have reported successful laparoscopic Burch procedures with gas laparoscopy.11–13 They may not benefit from a gasless approach. However, in the hands of a practicing obstetrician/ gynecologist or urologist novice at laparoscopic surgery, those results may be not be replicated. Each participating surgeon performed at least three gasless laparoscopic Burch procedures before enrolling subjects in this study. The purpose of performing procedures before study initiation was to reduce the learning curve for a new procedure. Each of the surgeons found the technique simple to learn and analogous to the open procedure, thus facilitating learning of the technique. Whether the learning curve with gasless laparoscopy is indeed shorter than with gas procedures should be a subject of future study. Shortcomings of this study include the small number of subjects, lack of a comparative group, and lack of qualityof-life (QOL) assessment before and after surgery. This was intended to be a pilot study to demonstrate the ease of performance of the procedure by various surgeons. A
larger, prospective, randomized study would be necessary to prove its efficacy compared to the open procedure. In future studies, it will be important to assess QOL impact changes. As with any surgical procedure, technical problems can be encountered. The main problem encountered with this technique was difficulty exposing the space of Retzius in patients with previous abdominal surgery. Although the balloon dissector readily opened the retropubic space in most subjects, when scarring from previous surgeries was present additional dissection either bluntly or with surgical instruments was required. Our experiences with other subjects outside of this study have demonstrated the technical difficulties in performing the procedure in patients with previous retropubic operations. As such, the risk of bleeding and bladder trauma during dissection may make a previous bladder neck suspension a relative contraindication to this approach. Our blood loss was somewhat higher than reported for gas laparoscopic procedures. This may be due either to the larger needles used or the absence of the tamponading effect of increased intraabdominal pressure with gas laparoscopy. Although there is a reduced postoperative healing phase with laparoscopic surgery, it should not be assumed that the actual recuperation time after this procedure is shorter. Long-term success of anti-incontinence surgery is dependent on unstressed healing. At least 6 weeks of limited physical activity is crucial to the long-term success of reconstructive pelvic surgery. Thus, for this study, we requested that subjects limit their exertion to lifting no more than 5 lbs for at least 6 weeks. With the advent of new tension-free suburethral slings, the use of open and laparoscopic procedures has decreased. Greater simplicity, shorter operating times, and similar success rates to open procedures are attractive features of the new vaginal approaches.14 However, postoperative voiding dysfunction remains an important factor.15 As surgical experience expands, and techniques undergo the natural test of time, laparoscopic Burch procedures will find their niche among our available surgical treatments. Gasless laparoscopy appears to offer a viable alternative to laparotomy or gas laparoscopy in the performance of a traditional Burch colposuspension. References 1. Bergman A, Elia G: Three surgical procedures for genuine stress incontinence: Five-year follow-up of a prospective randomized study. Am J Obstet Gynecol 1995, 173:66–71. 2. Herbertsson G, Iosif CS: Surgical results and urodynamic studies 10 years after retropubic colpourethrocystopexy. Acta Obstet Gynecol Scand 1993, 72:298–301. 3. Liu CY: Laparoscopic retropubic colposuspension (Burch procedure). A review of 58 cases. J Reprod Med 1993, 38: 526–30. 4. Ross J: Laparoscopic Burch repair compared to laparotomy Burch for cure of urinary stress incontinence. Int Urogynecol J 1995, 6:323–8.
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5. Ou CS, Presthus J, Beadle E: Laparoscopic bladder neck suspension using hernia mesh and surgical staples. J Laparoendosc Surg 1993, 3:563–6.
11. Kung RC, Lie K, Lee P, et al: The cost-effectiveness of laparoscopic versus abdominal Burch procedures in women with urinary stress incontinence. J Am Assoc Gynecol Laparosc 1996, 3:537–44.
6. Hanna SL, Chin A: Laparoscopic retropubic urethropexy. J Am Assoc Gynecol Laparosc 1996, 4:47–52.
12. Ross JW: Multichannel urodynamic evaluation of laparoscopic Burch colposuspension for genuine stress incontinence. Obstet Gynecol 1998, 91:55–9.
7. Moehrer B, Ellis G, Carey M, et al: Laparoscopic colposuspension for urinary incontinence in women (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software. CD002239. 8. Flax S: The gasless laparoscopic Burch bladder neck suspension: Early experience. J Urol 1996, 156:1105–7.
13. Lyons TL: Minimally invasive treatment of urinary stress incontinence and laparoscopically directed repair of pelvic floor defects. Clin Obstet Gynecol 1995, 38:380–91.
9. Carter JE: Laparoscopic Burch procedure for stress urinary incontinence: The Carter modification. Keio J Med 1996, 45:168–71.
14. Ulmsten U, Henriksson L, Johnson P, et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996, 7:81–5.
10. Gunn GC, Cooper RP, Gordon NS, et al: Use of a new device for endoscopic suturing in the laparoscopic Burch procedure. J Am Assoc Gynecol Laparosc 1994, 2:65–70.
15. Wang KH, Neimark M, Davila GW: Voiding dysfunction following TVT procedure. Int Urogynecol J 2002, 13:353–7.
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The Journal of the American Association of Gynecologic Laparoscopists
Prospective Trial of Gasless Laparoscopic Burch Colposuspension Using Conventional Surgical Instruments G. Willy Davila, M.D., Edward Stanford, M.D., and Abner Korn, M.D.
Abstract
(J Am Assoc Gynecol Laparosc 2004, 11(2):197–203)
Study Objective. To prospectively evaluate the use of gasless laparoscopy techniques in the performance of a traditional Burch colposuspension in women with urodynamically-demonstrated genuine stress incontinence and urethral hypermobility. Design. Multicenter, prospective, single-intervention series (Canadian Task Force Classification II-2). Setting. Three urogynecologic referral centers. Patients. Fifty-eight women. Intervention. Traditional Burch colposuspension performed utilizing gasless laparoscopic access and conventional surgical instruments. Measurements and Main Results. Follow-up was 12 to 38 months. On pad testing, urine loss was significantly reduced, from 6.0 g (CI: 0.55–11.45) to 0.3 g (CI: 0–1.53). Average daily incontinence episodes based on 7-day voiding diaries decreased from 4.7 (CI: 0.87–8.53) to 0.3 (CI: 0–1.58). Q-tip angles were normalized: 49.8 degrees (CI: 40.86–58.74) to 10 degrees (CI: 1.49–18.51). Ninety-five percent of subjects reported resolution of stress incontinence. Three subjects (5%) reported recurrent/persistent genuine stress incontinence: one was operated on during the postpartum period while breastfeeding, and two developed intrinsic sphincteric deficiency postoperatively. Fifty-five percent of subjects underwent other pelvic reconstructive surgery including posterior wall repairs. Average operative time was 60.8 minutes (range, 40–92). The ideal candidate has an unscarred abdominal wall. Conclusion. Gasless laparoscopic access was used to effectively perform traditional Burch colposuspension using conventional open surgical instruments. Bladder neck hypermobility was normalized in all subjects, and 95% of subjects reported no further stress incontinence.
ing utilizing surgical staples and synthetic mesh.5,6 These laparoscopic approaches have been popularized, although long-term outcome data are not available, and should not be equated to that of traditional Burch procedures. Using conventional surgical instruments may help reduce the learning curve for performance of a laparoscopic Burch procedure. The purpose of this prospective study was to evaluate the performance of a traditional Burch procedure, with the same suture materials and suturing techniques, using gasless laparoscopic equipment. Gasless laparoscopy allows for use of routine open operating instruments, sutures, and needles, thus simplifying the actual surgical approach.
Surgical approaches to stress incontinence have been based on reducing bladder neck mobility by suspension of para-urethral fascia to a strong pelvic or abdominal structure. Outcome studies have identified the Burch colposuspension as the technique with the best long-term success rates.1,2 Since this procedure traditionally requires a laparotomy incision, there have been multiple reported attempts at performing the same procedure laparoscopically. Using gas laparoscopy and laparoscopic instruments, Burch procedures have been reported with satisfactory objective short-term results.3 A prospective study comparing open to laparoscopic procedures demonstrated similar short-term success rates.4 Performance of laparoscopic Burch procedures using the same suturing techniques and placement as during an open procedure has challenged even the best gynecologic surgeon. Alternative laparoscopic approaches to bladder neck suspension procedures have been developed, includ-
Materials and Methods Women with stress urinary incontinence with associated urethral hypermobility who were candidates for traditional Burch colposuspensions were offered enrollment
From the Cleveland Clinic Florida, Weston, Florida (Dr. Davila); St. Mary’s/Good Samaritan, Centralia/Mt. Vernon, Illinois (Dr. Stanford); and the University of California, San Francisco, California (Dr. Korn). Corresponding author G. Willy Davila, M.D., Cleveland Clinic Florida, 2950 Cleveland Clinic Boulevard, Weston, FL 33331. Supported in part by Origin Medsystems, Menlo Park, California. Submitted June 18, 2003. Accepted for publication January 7, 2004. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, May 2004, Vol. 11 No. 2 © 2004 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.
197
Gasless Laparoscopic Burch Colposuspension Davila et al
at three urogynecologic clinical centers. This study received approval by the institutional review board at each institution, and all subjects signed an informed consent document. All terminology used was in accordance with International Continence Society standards except where noted. Before enrollment, subjects underwent full urogynecologic evaluation in order to diagnose genuine stress incontinence and document urethral hypermobility. The evaluation consisted of a complete history and physical examination including a pelvic examination to assess pelvic supports. Urethral mobility was evaluated with a cotton swab stress test. Laboratory testing included a urinalysis and pregnancy test for women of childbearing potential. Multichannel urodynamic evaluation included uroflowmetry, resting-empty and full-bladder urethral pressure profilometry, medium fill subtracted water cystometry, and stress cough urethral pressure profilometry. Catheterized postvoid residual urine was measured to rule out urinary retention. Cystometry was performed using room temperature sterile water at a fill rate of 80 mL/min with the subjects standing and performing multiple provocative maneuvers. Urethral pressure profiles (UPP) were performed with the patient supine and a double transducer microtip catheter withdrawn by a puller arm. A cough urethral profile pressure transmission ratio was calculated as an average of the cough-induced pressure changes in the proximal half of the urethra. Cystourethroscopy was performed in order to identify any abnormality of lower urinary tract anatomy and evaluate bladder neck mobility. Following urodynamic testing, all subjects received antibiotic prophylaxis for 24–48 hours. For enrollment, subjects
had to be symptomatic of stress incontinence and have a urodynamic diagnosis of genuine stress incontinence with urethral hypermobility. Patients with maximum UPP <20 cm H2O were excluded. We chose not to enroll patients with previous bladder neck suspensions due to the likelihood of significant retropubic scarring. Incontinence severity was assessed utilizing a standardized pad test and a 7-day bladder diary. This assessment was performed preoperatively as well as at 12-weeks and 1-year postoperatively. Outcome measures included changes in severity parameters as well as changes in Q-tip angle from the preoperative measured angle. Surgical Technique The operation is performed with the patient in low lithotomy position. A Foley catheter is placed for bladder drainage. The Laparolift gasless laparoscopy system (Origin Medsystems, Menlo Park, California) was used for all the surgical procedures. This system uses a mechanical lifter to elevate the anterior abdominal wall. The lifting arm is attached to the operating table at the level of the patient’s right shoulder, with the abdominal wall being elevated at the level of the umbilicus (Figure 1). For this series, a preperitoneal approach was used. A small subumbilical incision is made, and the dissecting balloon is placed subfascially in the preperitoneal space. The balloon is advanced to the level of the pubic bone, and the balloon is filled using a manual pump, with simultaneous laparoscopic visualization from within the balloon. Once the balloon is fully distended and the space of Retzius is satisfactorily dissected open (Figure 2), the balloon is deflated and removed. A fan-shaped attachment is placed such that the arms are
FIGURE 1. The Laparolift mechanical arm in position for gasless laparoscopic surgery.
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A
B
Figure 2. Laparoscopic view of the space of Retzius through the dissecting balloon with ample expansion of the operative field. (A) Lateral view with balloon in place. (B) View of dissected retropubic space through laparoscope.
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Gasless Laparoscopic Burch Colposuspension Davila et al
Results Fifty-eight women were enrolled and underwent the laparoscopic Burch colposuspensions, with follow-up visits at 12–38 months. Average age was 49 years (range 30–80). Preoperative pad testing showed an average urine loss of 6.0 g (CI: 0.55–11.45). This decreased to 0.3 g (CI: 0–1.53) postoperatively (p < .05). Average daily incontinence episodes decreased from 4.7 (CI: 0.87–8.53) preoperatively to 0.3 (CI: 0–1.58) postoperatively (p < .05). Additionally, Q-tip angles were normalized (normal = <30 degrees from horizontal plane), decreasing from 49.8 degrees (CI: 40.86–58.74) preoperatively to 10 degrees (CI: 1.49–18.51) postoperatively (p < .05). Three (5%) subjects reported recurrent stress incontinence during follow-up. One had undergone surgery during the postpartum period while breastfeeding. Her vaginal mucosa was markedly atrophic, and it was thought that her endopelvic fascia was likely still weak from her pregnancy and lactational hypoestrogenism. The remaining two women were noted to have intrinsic sphincteric deficiency on postoperative urodynamics. Both had negative Q-tip angles and underwent collagen injections with a successful outcome. Fifty-five percent of the women underwent other pelvic reconstructive procedures including posterior wall repairs. Operative time for the laparoscopic procedure averaged 60.8 minutes (range, 40–92) from umbilical incision to closure of all incisions. No bladder or ureteral trauma was noted. No infectious complications were noted. Estimated blood loss in all cases was less than 400 mL for the laparoscopic Burch, and no transfusions were required.
located under the belly of each rectus muscle, directed toward each inguinal area. The fan is then attached to the Laparolift, and the preperitoneal abdominal wall is elevated. A zero degree laparoscope is then inserted immediately below the fan, allowing visualization of the operating field. Two 2-cm operating instrument access ports are then sharply created, approximately 3 cm above each Cooper’s ligament. These ports are kept open by using a small Deaver or “S” retractor. No trocars are necessary as the operating space does not require a pneumatic seal. Standard operating instruments are then inserted through the operating ports (Figure 3). Sponge sticks can be placed to aid in dissection of the bladder and connective tissue off of the peri-urethral fascia for placement of the suspensory sutures. If bleeding occurs at anytime during the operation, a standard wall suction cannula or hand-held electrocautery unit can be used. Once the bladder has been satisfactorily mobilized, a standard needle driver and suture can be inserted. For this series, we used CV-2 Gore-Tex sutures on THX-26 or THX-25 needles—standard suture and needles that are used for open Burch procedures. Two figure-of-eight sutures were placed on either side of the urethra, at 2- and 4-cm lateral to the urethrovesical junction (Figure 4). They were then passed through the ipsilateral Cooper’s ligament, in a manner analogous to the open procedure. Cystoscopy was performed to confirm bladder integrity and ureteral function. The knots are then tied digitally (i.e., without a knot pusher) to normalize bladder neck support (Figure 5). The skin incisions were closed. Additional pelvic procedures were then performed as required for each individual patient.
FIGURE 3. Conventional open operating instruments.
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FIGURE 4. Two stitches bilaterally in completed gasless Burch procedure.
FIGURE 5. Knots being pushed digitally.
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Gasless Laparoscopic Burch Colposuspension Davila et al
Discussion Gasless laparoscopy allows for the usage of conventional open surgery instruments in the performance of laparoscopic surgery, making it unnecessary to modify suture placement techniques. In this series, a traditional Burch colposuspension was performed using laparoscopic access. Suture type and placement was identical to that used during an open procedure. According to our short-term efficacy evaluation of this procedure, the success appears to be equivalent to that of the open procedure. Two subjects were noted to have de novo intrinsic sphincteric deficiency (maximal urethral closure pressure <20 cm water) as a cause of their surgical failure. This is likely not technique-dependent, as this can occur following open Burch procedures performed with similar suture placement. Significant advantages of this procedure include the usage of instruments with which the surgeon is likely to be familiar, ability to obtain tissue bites of similar thickness to the open procedure, and ability to tie knots digitally rather than using a knot pusher. Thus, some commonly encountered problems of laparoscopic surgery, such as long and cumbersome instruments and suboptimal tissue bites, are avoided. Previous reviews have suggested that laparoscopic Burch procedures may be associated with a poorer outcome than open procedures.7 Utilizing instruments and technique traditionally used for open procedures may thus improve laparoscopic Burch success rates. Many modifications of the traditional Burch procedure have been reported. The challenges of laparoscopic surgery have led to further procedural modifications that may affect long-term outcomes. Single bilateral tissue bites, usage of staples and mesh, and usage of sutures of lesser thickness have been reported for laparoscopic “Burch” procedures.5,6,8–10 Unless the procedure is performed as described for the open technique, it cannot be called a “Burch” procedure, and similar outcomes may not be realistic. Experienced laparoscopic surgeons have reported successful laparoscopic Burch procedures with gas laparoscopy.11–13 They may not benefit from a gasless approach. However, in the hands of a practicing obstetrician/ gynecologist or urologist novice at laparoscopic surgery, those results may be not be replicated. Each participating surgeon performed at least three gasless laparoscopic Burch procedures before enrolling subjects in this study. The purpose of performing procedures before study initiation was to reduce the learning curve for a new procedure. Each of the surgeons found the technique simple to learn and analogous to the open procedure, thus facilitating learning of the technique. Whether the learning curve with gasless laparoscopy is indeed shorter than with gas procedures should be a subject of future study. Shortcomings of this study include the small number of subjects, lack of a comparative group, and lack of qualityof-life (QOL) assessment before and after surgery. This was intended to be a pilot study to demonstrate the ease of performance of the procedure by various surgeons. A
larger, prospective, randomized study would be necessary to prove its efficacy compared to the open procedure. In future studies, it will be important to assess QOL impact changes. As with any surgical procedure, technical problems can be encountered. The main problem encountered with this technique was difficulty exposing the space of Retzius in patients with previous abdominal surgery. Although the balloon dissector readily opened the retropubic space in most subjects, when scarring from previous surgeries was present additional dissection either bluntly or with surgical instruments was required. Our experiences with other subjects outside of this study have demonstrated the technical difficulties in performing the procedure in patients with previous retropubic operations. As such, the risk of bleeding and bladder trauma during dissection may make a previous bladder neck suspension a relative contraindication to this approach. Our blood loss was somewhat higher than reported for gas laparoscopic procedures. This may be due either to the larger needles used or the absence of the tamponading effect of increased intraabdominal pressure with gas laparoscopy. Although there is a reduced postoperative healing phase with laparoscopic surgery, it should not be assumed that the actual recuperation time after this procedure is shorter. Long-term success of anti-incontinence surgery is dependent on unstressed healing. At least 6 weeks of limited physical activity is crucial to the long-term success of reconstructive pelvic surgery. Thus, for this study, we requested that subjects limit their exertion to lifting no more than 5 lbs for at least 6 weeks. With the advent of new tension-free suburethral slings, the use of open and laparoscopic procedures has decreased. Greater simplicity, shorter operating times, and similar success rates to open procedures are attractive features of the new vaginal approaches.14 However, postoperative voiding dysfunction remains an important factor.15 As surgical experience expands, and techniques undergo the natural test of time, laparoscopic Burch procedures will find their niche among our available surgical treatments. Gasless laparoscopy appears to offer a viable alternative to laparotomy or gas laparoscopy in the performance of a traditional Burch colposuspension. References 1. Bergman A, Elia G: Three surgical procedures for genuine stress incontinence: Five-year follow-up of a prospective randomized study. Am J Obstet Gynecol 1995, 173:66–71. 2. Herbertsson G, Iosif CS: Surgical results and urodynamic studies 10 years after retropubic colpourethrocystopexy. Acta Obstet Gynecol Scand 1993, 72:298–301. 3. Liu CY: Laparoscopic retropubic colposuspension (Burch procedure). A review of 58 cases. J Reprod Med 1993, 38: 526–30. 4. Ross J: Laparoscopic Burch repair compared to laparotomy Burch for cure of urinary stress incontinence. Int Urogynecol J 1995, 6:323–8.
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15. Wang KH, Neimark M, Davila GW: Voiding dysfunction following TVT procedure. Int Urogynecol J 2002, 13:353–7.
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