Outcomes Comparative Studies Complicationsand Costs Outcomes

When examining outcomes of Burch colposuspension procedures, a differentiation between procedures done with the true Burch-Tanagho technique and those utilizing multiple modifications in surgical techniques is important. The confusingly varied outcomes reported for the laparoscopic "Burch" result, in part, from a failure to make this differentiation between techniques.

We will delineate the outcomes from laparoscopic classical Burch technique verses "modified Burch" procedures. As stated earlier, the laparoscopic Burch will refer only to procedures utilizing the Burch-Tanagho technique and all other procedures will be called laparoscopic colposuspensions.

In their initial report, Vancaillie and Schuessler (4) duplicated the Marshall-Marchetti-Krantz laparoscopically. Subsequently, the same group (5) reported 10 laparoscopic Burch colposuspensions, utilizing one suture per side. Several series reported laparoscopic Burch success rates of 89% to 100% with one to two-year follow-up (Table 3) (6,7,8,32,34-38). Liu (6) reported on 107 cases with 97% subjective cure rate over a follow-up of 3 to 27 months. He had a 10% complication rate including four cystotomies and one kinked ureter. He reported high patient satisfaction.

Extracting data from six different studies (8,10,12,33,39,41), we demonstrated an objective cure rate of 91% at one year in 178 patients. The majority of these patients showed objective cure by multichannel urodynamic testing. In most of these studies, patients with detrusor instability and intrinsic sphincter deficiency were excluded. The de novo detrusor instability rate was less than 9% with one to two years of follow-up, which is lower than that reported in most open Burch colposuspension studies (42-45). On urodynamic testing, there was a significant increase in pressure transmission ratio, functional urethral length, and maximum bladder capacity. There was no significant change in maximal flow rate. Multiple laparoscopic procedures for total vaginal vault prolapse and genuine stress incontinence were performed (33), including the first reported laparoscopic paravaginal repair. With the laparoscopic Burch alone, 97% of the patients were discharged in less than 24 hours and 93% voided spontaneously prior to

TABLE S ■ Comparison of Laparoscopic versus Open Burch Colposuspension

Months follow-up:

Author (yr)

Study type

LSC

Open

Mean (range)

Objective cure (%)

Subjective cure (%)

LSC

Open

LSC

Open

p value

LSC

Open

p value

Burton (BB, B7)

P

3O

3O

12/3B

12/3B

73/BO

97/93

<0.05/<0.05

NR

NR

Ross (B)

R

32

3O

12

12

94

93

NS

NR

NR

Polascik (73)

R

12

1O

2O.B (B-29)

35.B (11-50)

B3

70

NS

NR

NR

Su (71)

P

4B

4B

>\12

>\12

B0a

9B

0.04

NR

NR

Lavin (70)

R

11B

52

B

B

73

77

B1

73

Miannay(B9)

R

3B

3B

12/24

12/24

NR

NR

79/BBa

B9/B4

NS/NS

Saidi (22)

R

7O

B7

12.9 (2-24)

1B.3 (B-30)

NR

NR

91.4

91.9

NS

Summitt (B9)

P

2B

34

12

12

93

BB

NS

NR

NR

Carey (BB)

P

9B

1O4

B

B

B9

B0

0.1

100

95

0.12

Fatthy (72)

P

34

4O

1B

1B

BBa

B5a

NS

NR

NR

Huang(74)

R

B2

75

12

12

NR

NR

B4

B9

0.49

aModified Burch with one suture per side.

Abbreviations: Study type: P prospecitve; R, retrospective; NR, not reported; NS, not significant.

aModified Burch with one suture per side.

Abbreviations: Study type: P prospecitve; R, retrospective; NR, not reported; NS, not significant.

There are numerous reports of modified laparoscopic colposuspensions with varying results. The majority of these modifications are attempts to minimize intracorporeal laparoscopic suturing in order to simplify the procedure.

We performed a randomized controlled study comparing laparoscopic suture Burch (35 patients) and laparoscopic staple-mesh colposuspensions (34 patients). At one year, the objective cure rates were 91% and 94%, respectively.

discharge. When combined with multiple repairs including laparoscopic hysterectomy, posterior vaginal repair, apical vault repair, and sacrocolpopexy, 91% of the patients were discharged in less than 48 hours. The few patients who experienced delayed voiding had substantial posterior repairs or preoperative maximum flow rates of <15 cc per second. In the absence of these two factors, it was uncommon for a patient to not be able to void on the first postoperative day.

Cooper et al. (38) reported on 113 women in a retrospective study, with a mean follow-up of eight months. A combination of transperitoneal (94) and extraperitoneal (21) approaches were used. There was an 87% subjective cure rate. Fourteen percent of these patients had mixed incontinence. There were 10 cystotomies, one inferior epigastric vessel injury, one vaginal tear, one suture in the bladder, and one possible enterotomy. Papasakelariou and Papasakelariou (32) reported a subjective cure of 91% at two years. Flax (46) used gasless laparoscopy to perform Burch colposuspensions in 47 patients. A balloon was used to open the retropubic space and then a laparolift system was used for exposure in placing four Burch sutures. Forty-four of 47 patients—a 90% cure rate— needed no pads with a mean follow-up of 8.2 months. Persson and Wolner-Hanssen (47), in a randomized controlled study of 161 patients, demonstrated the importance of two sutures per side in the laparoscopic Burch colposuspension. One group of 78 had one double-bite and the other group of 83 had two single-bite sutures on each side. At one year, the objective cure rate was 58% and 83%, respectively (p = 0.001). These findings support the necessity of two sutures per side for optimum results and give a possible explanation for the high failure rate reported by many with a single suture per side. Persson stopped this study before he reached adequate numbers of patients required to power the study, because of poor outcomes in patients with one suture per side.

There are numerous reports of modified laparoscopic colposuspensions with varying results. The majority of these modifications are attempts to minimize intracor-poreal laparoscopic suturing in order to simplify the procedure.

The staple-mesh technique was first reported in 1993 (48). After opening the space of Retzius and removing the fat from the paraurethral area, the vaginal hand elevates the tissue 2 cm lateral to the bladder neck and a one by three centimeter strip of Prolene hernia mesh is attached with two to three staples. With the tissue still elevated, the other end of the mesh is stapled to Cooper's ligament. All 40 patients, with a mean follow-up of six months, reported improved voiding and resolution or improvement of symptoms. At five years (49), 27 patients were seen in the office and seven returned questionnaires. The five-year success rate, defined as no recurrent leaking by history, was 88% (30 of 34 confirmed outcomes). These authors recommend this procedure for the advantages of a shorter learning curve and good outcome, as reported by others (50,51).

We performed a randomized controlled study comparing laparoscopic suture Burch (35 patients) and laparoscopic staple-mesh colposuspensions (34 patients). At one year, the objective cure rates were 91% and 94%, respectively.

In a work in progress, the five-year follow-up showed a significant difference, with an 84% cure for the suture group and 57% cure for the staple mesh (p < 0.003) (Ross, unpublished data). Reentry into the space of Retzius was extremely difficult in the staple-mesh group, secondary to extreme scarification. The mesh had pulled away from the pubocervical fascia in the several patients who had repeat surgery. We no longer use this technique due to our high long-term failure rate and the difficulty in additional surgery. Others (52,53) have reported similarly poor long-term outcomes.

McDougall (54) compared modified laparoscopic colposuspension to a Raz procedure, reporting similar one-year outcomes. In the laparoscopic colposuspension, two braided sutures were placed in the endopelvic fascia on each side and tied intracorpo-really. The sutures were then passed through Cooper's ligament and secured with a polydioxanone clip. In a retrospective long-term review (54) (mean 45 months, range 17-71 months), only 15 of 50 patients with laparoscopic colposuspension and 10 of 29 patients who underwent Raz procedures were continent. In addition, there was a 28% rate of urge incontinence. The failure of delayed absorbable clips could possibly play a role in the early poor outcomes reported. Two more studies reporting poor long-term outcomes used different ways of suturing. At 36 months, laparoscopic colposuspen-sions done with bone screws had a 40% cure rate by patient questionnaires Das. Lobel and Davis (57) used a variety of suturing techniques utilizing curved needles, straight needles, and Stamey needles. Many of these patients had one suture per side and at 36 months, the cure rate was 69% and improved 11%. There are several reports utilizing different types of needle to incorporate transvaginal tissue, transfix Cooper's ligament, or to fix sutures to the abdominal wall with buttons to complete a laparoscopic colposuspension (58-61) Harewood, (62). It is difficult to compare these studies to studies utilizing the traditional Burch-Tanagho procedure.

Other variations in sutures include a staple-suture procedure (63), in which a hernia stapler is used to staple a Gore-Tex suture to the pubocervical fascia and then to Cooper's ligament. The free ends of the suture are then tied with an extracorporeal knot to help set the height of elevation. No outcome data for the 60 patients treated with this technique have been published. In the Nolan-Lyons procedure (64), the pubocervical tissue is pulled up through an endoloop, which is tightened down to hold the tissue. The endoloop is used to pull the tissue to the desired elevation and then stapled to Cooper's ligament. Lyons reported a 92% subjective cure rate at 12 months. No long-term data have been reported. Kiilholma et al. (65) performed a modified colposuspension on 17 patients by applying fibrin sealant glue to the urethrovesical junction on each side of the bladder neck. Then, placing the first and middle finger in the vagina, the urethrovesical junction was pressed to the retropubic periosteum and held there for five minutes. Twelve patients were followed for 12 months; 10 reported being completely dry and two were improved.

In 1999, we reported an 85% objective cure rate at five years in a prospective longitudinal study of 87 women who had undergone laparoscopic Burch (41). Objective cure was defined as no evidence of genuine stress incontinence, detrusor instability, or intrinsic sphincter deficiency on urodynamic testing or CST. In addition, bladder neck ultrasound at maximum cystometric capacity was used on many patients. The laparo-scopic technique duplicated the open Burch-Tanagho except for the mode of entry into the space of Retzius. All patients voided spontaneously before discharge at 24 hours, or 48 hours if they had a concomitant laparoscopic hysterectomy. All patients were on oral pain medication in less than 12 hours. Treatment failures were greatest in the first year after surgery. There were no additional failures in the fourth year and only one in the fifth year. There was a positive correlation between failure and severity of pelvic organ prolapse at the time of repair.

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