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Sacrohysteropexy without mesh for apical prolapse versus a vaginal approach: a randomized-controlled trial

Maarouf, Taiseer

Journal of Evidence-Based Women’s Health Journal Society: August 2012 - Volume 2 - Issue 3 - p 80–83
doi: 10.1097/01.EBX.0000415773.10023.64
Original articles

Objective To evaluate the use of abdominal sacrohysteropexy for the treatment of uterine prolapse without using a mesh versus vaginal sacrospinous fixation in the treatment of uterovaginal prolapse.

Design Randomized-controlled trial.

Setting Tertiary referral center.

Participants and methods Women were randomized into two groups: group I included 20 women who had undergone abdominal sacrohysteropexy with no mesh for the treatment of uterine prolapse. Group II included 20 women who had undergone vaginal sacrospinous fixation. All women were diagnosed as having third-degree or fourth-degree uterovaginal prolapse.

Results There was no significant difference between both the groups in the intraoperative or postoperative complications. At the 1-year follow-up postoperatively, there was no statistically significant difference between both the groups in the anatomical results. There were two apical prolapse recurrences of grade two in both the groups with abdominal and vaginal operations.

Conclusion Sacrohysteropexy without a mesh is safe, easy, low cost, and effective, with the benefits of uterine preservation in comparison with vaginal operations.

Department of Obstetrics & Gynecology, Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt

Correspondence to Taiseer Maarouf, MD, Department of Obstetrics & Gynecology, Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt Tel: +20 122 366 0078; e-mail: taiseer.maarouf@gmail.com

Received December 21, 2011

Accepted January 14, 2012

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Introduction

Correction of apical support of pelvic prolapse is considered to be the foundation of prolapse surgery. The sacral colpopexy is an abdominal procedure that resuspends the vaginal apex to the anterior longitudinal ligament overlying the sacrum using graft material, and has often been cited as the ‘gold standard’ surgery for pelvic organ prolapse 1.

There has been huge concerns over mesh-related complications such as infection and erosion after the implantation of a foreign material in the human body. The rate of mesh erosion following the use of a synthetic mesh to provide apical support in abdominal repair has been reported to be 3.4–16%, although the mesh type and placement method were different 2,3.

Randomized-controlled trials are required for assessment of the safety and efficacy of fixation of the uterus or vaginal vault without the use of a mesh, using validated tools to measure anatomic and functional outcomes including quality of life 4. The present study aims to evaluate the use of abdominal sacrohysteropexy for the treatment of uterine prolapse without using a mesh versus vaginal operations in the treatment of uterovaginal prolapse.

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Patients and methods

The present study is a randomized-controlled study of women with uterine prolapse carried out in Al-Zahraa University Hospital. Forty women were randomized into two groups: group I included 20 who had undergone abdominal sacrohysteropexy with no mesh for the treatment of uterine prolapse and group II included 20 women who had undergone a vaginal operation: sacrospinous fixation. All women were diagnosed as having third-degree or fourth-degree uterovaginal prolapse. Written informed consent was obtained from all patients. Sample size was calculated using Epi Info version 6 (Atlanta, Georgia, USA). The power of the test was 80%. The confidence interval was 95%. The α error was 5%.

Every patient was assessed in terms of a history of diabetes mellitus, liver disease, ascites, chronic cough, constipation, difficulty in micturition, or a history of previous operations, especially operations for genital prolapse and abdominal masses.

All women were examined and pelvic floor defects were evaluated using POP-Q; the genital hiatus and perineal body were identified during the valsalva maneuver. The total vaginal length was then measured by placing marked ring forceps at the vaginal apex and noting the distance to the hymen. A bivalve speculum was inserted into the vaginal apex. It displaced the anterior and posterior vaginal walls, and points C and D were then measured. The speculum was then slowly withdrawn to assess descent of the apex. A split speculum was then used to displace the posterior vaginal wall and allow for visualization of the anterior vaginal wall and measurement of points Aa and Bb. The split speculum was then rotated 180° to displace the anterior vaginal wall and allow examination of the posterior vaginal wall. Points Ap and Bp were measured. If the posterior wall descended, we determine whether rectocele or enterocele was present. Enterocele can only definitively be diagnosed by the sensation of small bowel peristalsis behind the vaginal wall.

The pelvic organs were outlined by bimanual examination of pelvic organs for size and mobility. Rectal and rectovaginal examination was then performed for rectal pathology, rectal prolapse, and differentiation of enterocele and rectocele. The patient was then asked to cough or strain with the bladder full to detect stress incontinence.

Uroflowmetry was performed for all our patients before the procedure. Postvoid residual (PVR) was measured in our patients before the operation by ultrasound (PVR=0.52 [anteroposterior dimension (cm)+transverse dimension (cm)+midsagittal dimension) (cm)].

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Procedures performed

Abdominal sacrohysteropexy group

Twenty patients underwent abdominal sacrohysteropexy with uterine preservation. One stitch was fixed transversally to the anterior longitudinal ligament of the sacrum reaching the periosteum about 1 cm below the promontorium using nonabsorbable silk suture size 1 or 2 with a small but strong half-circle needle or using a mersilene tape. The prolapsed uterus was replaced in its proper position by inserting a vaginal pack.

The stitch was then inserted into the posterior surface of the uterus at the level of the uterosacral ligament. The uterus as then approximated to the sacrum until there was no space and then the suture was tied, ensuring that there was no space between the cervix and the sacrum. Round ligament plication was performed in all our patients to provide anterior support and prevent retroversion of the uterus.

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Sacrospinous ligament fixation

For proper suture placement, a window through the descending rectal septum over the ischial spine was created. Once established, the window was gently enlarged in the axis of the vagina. At a point 2–3 cm medial to the ischial spine, the sacrospinous ligament–coccygeus muscle complex was pierced by a full length of polypropylene suture (size 1) using a long needle holder and a conventional needle. These permanent sutures were placed submucosally in the vagina so that they were buried in the fibromuscular wall. The long colpopexy stitches were then held in hemostats to be tied later in the operation. The vagina was brought to the ligament by the pulley stitch. The vaginal suture end was tied to itself, making the posterior apex a fixed point. Using traction on the posterior limb of the suture, the vaginal apex was pulled directly onto the sacrospinous ligament. A square knot was used to fix it in place. Posterior colporrhaphy was then completed.

For all patients, the following data were collected: duration of surgery, amount of blood loss, complications during surgery, complications during hospital stay, duration of hospital stay, and later complications because of surgery. Patients in the two groups were followed up after 1 and 6 months. Data were analyzed statistically and compared between both the groups.

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Results

The patients recruited in this study had some risk factors of pelvic organ prolapse, such as high parity (3.650±1.531 and 3.100±1.682, respectively) and high BMI (32.5±4.9 and 30.9±4.5 kg/m2, respectively). At the 1-year follow-up postoperatively, there was no statistically significant difference between both the groups in terms of the anatomical results. There were two apical prolapse recurrences of grade two in both the groups that underwent abdominal and vaginal operations. The average operating time was 48 min for the vaginal operations group (group I) compared with 26 min for the abdominal sacrohysteropexy group (group II), which was statistically significant. Intraoperative blood loss was greater in the vaginal operation group but when compared with the sacrohysteropexy group, there was no statistically significant difference. Comparison of perioperative complications also did not show statistically significant differences between both the groups. Review of symptoms in both the groups during follow-up showed an association with dyspareunia in the vaginal operations group (Tables 1–4).

Table 1

Table 1

Table 2

Table 2

Table 3

Table 3

Table 4

Table 4

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Discussion

In the current study, half of the patients recruited underwent abdominal sacrohysteropexy. However, we performed fixation of the uterus at the level of the uterosacral ligament to the anterior longitudinal ligament without using a mesh; and the rest of the patients were managed by vaginal sacrospinous fixation.

The patients recruited in the present study had some of the risk factors of pelvic organ prolapse, such as high parity (3.650±1.531 and 3.100±1.682, respectively) and high BMI (32.5±4.9 and 30.9±4.5 kg/m2, respectively). About 25% of these patients were postmenopausal (six in the vaginal surgery group and four in the abdominal sacropexy group). None of the patients could recall the weights of their babies at birth. Two patients in the vaginal surgery group had undergone instrumental delivery. Less than half of the patients had been treated previously for repairs of pelvic organ prolapse and stress urinary incontinence in the form of classical repairs.

Most of the patients in this study were in grade III according to the POP-Q system for the evaluation of prolapse. Almost all the patients had similar complaints, among which mass protrusion, pelvic discomfort, and pelvic and back pain were the most distressing and were the main symptoms for which they sought medical attention and intervention; among sexually active women, most of them had sexual complaints.

In our study, it was found that abdominal sacropexy was a safe operation, with no reported cases of rectal injury or massive bleeding, and a shorter operative time (26.750±10.915) in relation to vaginal surgery (48.750±15.379) as the technique of fixation is easy and rapid, involving only one tight suture that fixed the uterus to the sacrum.

There are three major controversies associated with a uterus-sparing surgery for POP. First, many surgeons believe that hysterectomy prevents prolapse recurrence, because the presence of the uterus might subject pelvic reconstruction to undue stress. However, hysterectomy-associated pelvic floor dissection might increase the risk of pelvic neuropathy and disrupt natural support structures, such as the uterosacral cardinal ligament complex 5. Second, uterus preservation may expose the patient to potential pathologies (such as cancer) in what might be considered an almost useless organ. However, after subtotal abdominal hysterectomy, the risk of cervical cancer is less than 0.1%, whereas the incidence of endometrial cancer is 0.2% 6. The third point is related to the complications that are associated with hysterectomy. Some studies have reported that abdominal or vaginal hysterectomy may be associated with de novo or worsening symptoms of urinary incontinence 7.

In the present study, in terms of concomitant posterior repair, about 25% of the patients did it with no difference in outcome between who did or not. Our study showed that apical support was adequate to support the posterior compartment; hence, there was no need for concomitant posterior repair with abdominal sacropexy. However, 65% of patients had undergone posterior repair in the vaginal operation group as a complementary technique in the operation.

In our study of 20 patients, 90% of them were group I after the 6-month follow-up and 10% of them were group II prolapse, and this case of recurrence was because of an intraoperative technical fault, and the remaining 90% showed marked improvement in prolapse symptoms and quality of, also, sexual complaints markedly improved after the operation because of maintenance of vaginal length, in comparison with a 70% success rate in the vaginal surgery group, which record 20% group I and 10% group II in the form of vault prolapse and recurrent anterior wall prolapse. Patients who had undergone abdominal sacropexy had shorter hospital stay (46.200±10.501 h) in comparison with the vaginal group (62.400±12.063 h).

Most postoperative complications could be avoided by administration of prophylactic antibiotics, early ambulation, and careful postoperative observation. Two patients developed postoperative fever that was mild and did not exceed 38°C, and improved with antipyretics. Also, three patients complained of backache that was present more than 1 month after the operation, and in one patient, it was present after the 6-month follow-up. The condition was managed by an analgesic and an injection of vitamin B complex, and it was mostly because of a preoperative problem as some patients with backache showed marked improvement after the operation. One patient experienced delayed intestinal movement for 3 days, and investigations showed no evidence of intestinal obstruction, and she already had a history of constipation.

Complications associated with abdominal sacral hysteropexy seem to be comparable with those associated with sacral colpopexy. Other investigators have obtained a 7% rate for intraoperative complications and a 13% rate for minor postoperative complications. In this study, only one patient developed mesh erosion that was observed 2 years after surgery, and another patient developed a bowel obstruction secondary to occlusion by the mesh 4 years after surgery. In addition, postoperative pregnancy was reported in one study that indicated that six patients wished to conceive after surgery, with only three documented pregnancies occurring 3–6 years after the procedure 7.

Another question that requires answering is as follows: what are the definitions of success and cure in pelvic organ prolapse surgeries? The definition of surgical success after prolapse repair is not standardized. Subjective definitions of cure include patient satisfaction and symptomatic improvement, whereas objective definitions include functional and anatomic outcomes. Traditionally, outcomes have been reported in terms of anatomic results, that is reduction in the degree of prolapse. Unfortunately, because of multiple prolapse grading systems and varying definitions of recurrence used throughout the literature, there is no consensus on any one measurement outcome. Further, most studies have reported that perfect anatomy after repair is not a necessity for good outcomes. Clearly, the evaluation and determination of outcomes as well as the significance of those outcomes after prolapse repair are ill defined, leading to considerable difficulty in the comparison of studies and their results 8. In a recent study carried out by Barber et al. 9, 18 different definitions of surgical success were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. Treatment success varied widely (19.2–97.2%) depending on which definition was used. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient’s assessment of overall improvement, whereas anatomic success alone does not. This leads to the following question: ‘Are we curing anatomy or curing symptoms?’ In the current study, it was difficult to define cure or success anatomically, functionally, or subjectively because of the lack of long-term follow-up data of these patients.

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Conclusion

In conclusion, the use of our technique in sacrohysteropexy in the treatment of apical prolapse is safe, easy, low cost, and effective, with the benefits of uterine preservation. In comparison with a vaginal operation, almost the same anatomical results are obtained, with less operative hospital stay, fewer complications, and greater patient satisfaction because of preservation of the uterus and improvement in prolapse-induced urinary symptoms and sexual dysfunction. There is a need for large randomized-controlled trials evaluating the efficacy of this different technique, its applicability using laparoscopy, and the use of different types of suture materials.

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Acknowledgements

Conflicts of interest

There are no conflicts of interest.

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References

1. Brubaker L, Nygaard I, Richter HE, Visco AG, Weber A, Cundiff G, et al. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008;112:49–55
2. Brizzolara S, Pillai Allen A. Risk of mesh erosion with sacral colpopexy and concurrent hysterectomy. Obstet Gynecol. 2003;102:306–310
3. Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, et al. Risk factors for mesh/suture erosion following sacrocolpopexy. Am J Obstet Gynecol. 2008;199:688.e1–688.e5
4. Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, et al. Abdominal sacrocolpopexy with burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006;354:1557–1566
5. Dwyer PL, Fatton B. Bilateral extraperitoneal uterosacral suspension: a new approach to correct posthysterectomy vaginal vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:283–292
6. Slieker Ten Hove MCP, Pool Goudzwaard AL, Eijkemans MJC, Steegers Theunissen RPM, Burger CW, Vierhout ME. The prevalence of pelvic organ prolapse symptoms and signs and their relation with bladder and bowel disorders in a general female population. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:1037–1045
7. Costantini E, Lazzeri M, Porena M. Hysterectomy and stress urinary incontinence. Lancet. 2008;371:383
8. Kapoor DS, Sultan AH, Thakar R, Abulafi MA, Swift RI, Ness W. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118–123
9. Barber MD, Visco AG, Wyman JF, Fantl JA, Bump RC. Sexual function in women with urinary incontinence and pelvic organ prolapse. Obstet Gynecol. 2002;99:281–289
Keywords:

follow-up; prolapse; sacrohysteropexy; sacrospinal fixation

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