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ORIGINAL RESEARCH |
From the *Department of Obstetrics and Gynecology and Department of Biometry and Medical Documentation, University of Ulm, Ulm, Germany.
Address reprint requests to: Felix Flock, MD, Department of Obstetrics and Gynecology, University of Ulm, Prittwitzstr. 43, 89075 Ulm, Germany; e-mail: felix.flock{at}medizin.uni-ulm.de.
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ABSTRACT |
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METHODS: Over a 5-year period the clinical course of all 336 consecutive patients undergoing TVT procedure in our hospital was recorded, including diagnostic approaches and management strategies for both increased intraoperative blood loss and clinically relevant hematoma.
RESULTS: In 87 patients (26%), TVT procedure was combined with other gynecologic surgeries, and 249 patients (74%) underwent TVT alone. In 7 cases (2.1%), increased intraoperative blood loss (250–400 mL) was managed by electro-coagulation, manual compression, tamponade, and/or insertion of a drain. The postoperative course in these patients was uncomplicated. In 14 women (4.1%) who did not show increased bleeding during the operation, retropubic hematoma developed, the volume of which exceeded 300 mL in 4 cases (1.2%). These required surgical intervention. In the first case we performed open laparotomy, whereas in the following cases the hematoma could be successfully drained by endoscopy. Postoperative development of a hematoma did not lead to recurrence of stress incontinence.
CONCLUSION: Bleeding complications during or after TVT procedure are rare events. Increased intraoperative bleeding can usually be managed with electro-coagulation, compression, and drainage.
LEVEL OF EVIDENCE: II-3
A low rate of complications is an important advantage of the TVT procedure. Bladder injury and postoperative urinary retention have been reported. Bleeding complications were mentioned infrequently and have not been described in detail.7–13 In the present study we investigated the incidence, short-term and long-term sequelae, as well as the clinical management of bleeding complications associated with TVT procedure in a large series of patients.
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METHODS |
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The use of drugs that affect platelet function, such as aspirin, was stopped at least 1 week before the procedure. Preoperative thrombosis prophylaxis was not used routinely. If needed, low-molecular-weight heparin (Certoparin 3000 IE anti-Xa, Novartis, Germany) was given 24 hours before the operation. Preoperative complete blood count and coagulation studies were performed routinely.
The TVT procedure performed in our department is a modification of the method described by Ulmsten et al.2 Xylocaine (0.5%) is used for local anesthesia, together with continuous intravenous application of remifentanil 150–250 µg/h. No epinephrine is added for local infiltration. After insertion of the tape, cystoscopy is performed. The procedures were carried out by one of the authors (F.F. or A.R). When combined with other surgery, the TVT procedure was performed last.
About 6 hours after surgery, low-molecular-weight heparin was given routinely. Patients were discharged on the second postoperative day. Every patient underwent a standard pelvic examination, including inspection of the anterior vaginal wall and bimanual palpation. In case of postoperative problems, such as excessive pain, skin hematoma, a palpable mass above the symphysis, or signs of circulatory failure, this evaluation was performed immediately. If a mass was palpable behind or above the pubic bone or if there was significant tenderness, an abdominal and transvaginal ultrasonography was carried out. A hematoma was characterized by an echo-free or hypoechogenic, nonhomogeneous structure beside the urinary bladder (Fig. 1, A and B). The volume of the hematoma was calculated by the formula, D1 x D2 x D3 x 0.6, with D1, D2, and D3 being orthogonal diameters. If the diagnosis of a hematoma was made, a complete blood count and coagulation studies were drawn.
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Checking for possible risk factors for bleeding complications was performed by 
2 test. Absolute numbers, percentages, and 95% confidence intervals (CI) are reported. P < .05 was considered significant.
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RESULTS |
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An increased intraoperative blood loss of more than 200 mL, based on subjective assessment of the surgeon, was observed in 7 patients (2.1%). In 3 of these cases, a bleeding artery at the incision site could be electro-coagulated. Additionally, manual compression of the paraurethral and retropubic region was applied for 5–10 minutes. As the increased bleeding tendency was generally evident before the plastic sheath covering the tape was removed, we inserted redon drains (10 Ch; PFM-AG, Cologne, Germany) into the vaginal end of the sheath at both sides. After the drains became visible at the skin incision, they were positioned within the paraurethral and retropubic region. The tape was then adjusted and the plastic sheaths carefully removed from the tape and drains by an assistant. Thus, the drains were located in intimate proximity to the potential bleeding site. In addition, vaginal packing was performed for 24 hours. The drains were removed after 24–48 hours. The postoperative course in these patients was uncomplicated. Maximal blood loss through the drains was 80 mL.
Fourteen patients (4.1%) developed retropubic hematoma. In 10 cases the sonographically estimated volume was 40–200 mL and in 4 cases, 300–1000 mL. We were unable to identify any specific risk factor for this complication. No patient with hematoma had a history of an incontinence procedure. Obesity with a body mass index greater than 30 was not more common within this group (2/14 patients [14.3%, 95% CI 1.8–42.8%] versus 58/322 [18%, 95% CI 14–22.7%]; P = 1.0). Neither did combination of TVT with other procedures affect the incidence of hemorrhagic complications when compared with isolated TVT (5/87 patients [6%, 95% CI 1.9–12.9%] versus 9/249 [3.6%, 95% CI 1.7–6.8%]; P = .59). Preoperative use of low-molecular-weight heparin was associated with hematoma in one case.
Five patients (all with hematoma < 100 mL) had minor symptoms or none, whereas all the patients with hematomas greater than 100 mL complained of moderate (n = 6) to severe (n = 3) pain. Severe pain was associated with hematoma greater than 300 mL. There was one occurrence each of a fall in blood pressure and urgency/frequency, both in patients with a large hematoma. In the 4 patients with severe hematoma (volume 300–1000 mL), the hematocrit decreased from 36–41%, preoperatively, to 24–29%, postoperatively. All patients with hematoma less than 200 mL had hematocrit greater than 33%, postoperatively.
The 4 patients with a hematoma size of 300 mL or greater required surgical removal of the hematoma. In 3 cases this was performed on the first postoperative day. One patient refused early intervention, although the hematoma amounted 380 mL. Because of ongoing pain and severe urgency and frequency, surgical revision was performed 5 weeks later. At that time the size of the hematoma had increased to 500 mL.
The surgical revisions were done under spinal (n = 1) or general (n = 3) anesthesia. The first patient underwent laparotomy for removal of large blood clots within the space of Retzius and insertion of 2 soft drains (20 Ch; PFM-AG, Cologne, Germany). Only mild active bleeding was present at the os pubis next to the tape.
In the following 3 patients, we performed an endoscopic approach with laparoscopic instruments. A 1-cm trocar was inserted directly into the mass, which in these patients was easily palpable. After aspiration of the hematoma by an Olsen aspiration cannula (Karl Storz, Tuttlingen, Germany), the space of Retzius was insufflated with carbon dioxide. Under direct visual control, a second trocar was inserted into this cavity. A careful revision with removal of residuals of the hematoma and coagulation of bleeding sites was performed (Fig. 2), followed by insertion of soft drains. We were unable to identify significant active bleeding in all these patients. Two patients received blood transfusions. Postoperative ultrasound examination revealed residual hematoma of 80–120 mL in 3 cases, without any clinical symptoms. All patients were discharged from the hospital within 1 week.
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The patients with hematomas of 100–200 mL (n = 5) complained of moderate pain. Therefore, we attempted needle aspiration, but, in all but one case, this was unsuccessful because of clotting. With the patients’ consent, we did not proceed to further surgical steps.
Sonographic follow-up was performed in all patients with hematomas (both with and without surgical revision). In 5 patients who did not undergo revision, the hematoma was still present at the time of regular follow-up after 10 weeks, but declining in size (up to 40 mL). Complete resolution in all patients was confirmed after 2–5 months.
All but one of the patients with a hematoma were completely continent 10 weeks after surgery, and that did not change during the time of resolution of the hematoma. One patient, who preoperatively suffered from combined incontinence, complained of ongoing urge incontinence. To date, 10 patients have been followed-up for a period of 5–25 months (median 16 months), and their outcomes have not deteriorated.
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DISCUSSION |
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Increased intraoperative bleeding is mostly caused by injured vaginal or paraurethral vessels. This can usually be managed by electro-coagulation, manual compression, or vaginal packing. Because we often do not know the exact location of the bleeding—ie, retropubic space or the vaginal wall—we usually proceed to insert redon drains. This measure may reduce the risk for retropubic hematomas because we did not observe those in patients managed by redon drain insertion. In these cases the drains yielded only a little blood. This is probably due to the suction provided by this vacuum drainage system, which may lead to an occlusion of the wound cavity. Therefore, this easy-to-perform and inexpensive maneuver may be beneficial in patients with increased bleeding during TVT.
We did not observe massive bleeding during surgery, although this has been reported occasionally in the literature.9,12 In these cases the excessive bleeding was caused by injury of an artery behind the symphysis or the external iliac vessels, and laparotomy was required. Muir et al16 in a cadaver study showed that the major vessels in the retropubic space and anterior abdominal wall lie 0.9–6.7 cm lateral to the TVT needles. However, if the needle is guided laterally, injury, especially of the external iliac vein, is imminent.
Together with other authors,9,12 we speculate that most postoperative hematomas after TVT procedure are caused by injury of the perivesical plexus. This speculation is supported by the fact that we could not identify any injury to major vessels in patients with massive hematomas. Similar complications are also known after other types of retropubic incontinence surgeries, with a frequency of 0.2–7%.17 Rates of vascular injury after TVT and colposuspension procedure did not differ significantly in a randomized controlled trial.8 The size of retropubic hematomas after TVT procedure ranges considerably, from a few milliliters up to more than a liter. Usually, a hematoma can be diagnosed by clinical examination and ultrasonography. However, the amount of blood loss is often underestimated because of spreading of the hematoma into the retroperitoneal space.9 Therefore, the clinical monitoring and management of patients with bleeding complications after TVT procedure should not only be based on results of the ultrasound examination, but also on careful clinical assessment of the patient's status, especially taking into account pain, circulatory disturbance, and the fall of hematocrit.
In our series one patient developed urgency and frequency after surgery because of a large mass in the cavum Retzius leading to bladder compression, requiring surgical revision 5 weeks later. Karram and colleagues9 reported a similar case, with spreading of the hematoma into the retroperitoneal space. Pain and discomfort led to surgical intervention after 6 weeks.
Most hematomas do not cause any, or only minor symptoms; thus, usually no intervention is necessary. In our experience a hematoma volume of more than 300 mL is usually associated with severe symptoms, and evacuation of the hematoma is indicated. As a first step, a puncture of the hematoma using at least an 18-gauge needle should be attempted.
However, most hematomas will be diagnosed only after some delay, so puncture and aspiration will often fail. For these cases we describe retziuscopy as a minimally invasive surgical intervention. In most patients this approach will lead to sufficient evacuation of the hematoma, and drains can be correctly placed. In addition, we are concerned that during a laparotomy the tape might be stretched by separating the rectus muscles. This could very well alter the tension of the tape and, therefore, lead to over-correction. Endoscopic management will likely avoid this complication.
In conclusion, retropubic hematomas are rare but typical complications during or after TVT procedure, occurring in 1–4% of cases. In cases of large masses, intervention is warranted because of significant discomfort. This can usually be achieved by retziuscopy. Open surgery is only required if the endoscopic approach should fail to control active bleeding.
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Footnotes |
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doi:10.1097/01.AOG.0000140680.30065.61
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REFERENCES |
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2. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol 1999;106:345–50.[Medline]
3. Nilsson CG, Kuuva N, Falconer C, Resapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):5–8.
4. Olsson I, Kroon U. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 1999;48:267–9.[Medline]
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6. Debodinance P, Delporte P, Engrand JB, Boulogne M. Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations. Eur J Obstet Gynecol Reprod Biol 2002;105:49–58.[Medline]
7. Meschia M, Pifarotti P, Bernasconi F, Guercio E, Maffiolini M, Magatti F, et al. Tension-free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(suppl 2):S24–7.
8. Ward K, Hilton P. Prospective multicenter randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67–73.
9. Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929–32.
10. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81:72–7.[Medline]
11. Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol 2001;98:732–6.
12. Vierhout ME. Severe hemorrhage complicating tension-free vaginal tape (TVT): a case report. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:139–40.[Medline]
13. Zilbert AW, Farrel SA. External iliac artery laceration during tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:141–3.[Medline]
14. Ingelman-Sundberg A, Ulmsten U. Surgical treatment of female urinary stress incontinence. Contrib Gynecol Obstet 1983;10:51–69.[Medline]
15. Zufferey P, Laporte S, Quenet S, Molliex S, Auboyer C, Decousus H, Mismetti P. Optimal low-molecular-weight heparin regimen in major orthopedic surgery: a meta-analysis of randomised trials. Thromb Haemost 2003;90:654–61.[Medline]
16. Muir TW, Tulikangas PK, Fidela Paraiso M, Walters MD. The relationship of tension-free vaginal tape insertion and the vascular anatomy. Obstet Gynecol 2003;101:933–6.
17. Chaliha C, Stanton SL. Complications of surgery for genuine stress incontinence. Br J Obstet Gynecol 1999;106:1238–45.[Medline]
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