Adhesion Prevention: What are my Options in Gynecological Surgery? (2024)

Adhesion Prevention: What are my Options in Gynecological Surgery? (1)

How Common are Adhesions?

Post-surgical adhesion formation is the most common complication of abdominal or pelvic surgery.1Adhesiolysis is currently the standard treatment approach, but in approximately 85% of patients, adhesions can reform.2,3Thus, optimal strategies are related to minimizing or preventing adhesion formation in the initial surgery.

Solutions for Adhesion Prevention

Adhesion Prevention: What are my Options in Gynecological Surgery? (2)

Meticulous Surgical Technique4,5

Minimize tissue damage5–7

Gentle tissue handling5–7

Optimal hemostasis5–7

Avoiding tissue desiccation5–7

Preventing thermal injury, foreign body reaction, and infection5–7

A systematic review and meta-analysis of the effect of surgical approach on the incidence of adhesion-related complications found no indication that minimally invasive techniques (e.g., laparoscopy) could improve outcomes5,8

Adhesion Prevention: What are my Options in Gynecological Surgery? (3)

Pharmacological Agents

Suppress inflammatory reactions and pathophysiological processes necessary for the formation of adhesions through the use of drugs targeting adhesion mechanisms4,5,9

Anticoagulants4

Fibrinolytics4

Anti-inflammatory agents4

Antibiotics for the prevention of infection4

Clinical use is limited by potential off target and adverse effects, such as uncontrolled bleeding5

Adhesion Prevention: What are my Options in Gynecological Surgery? (4)

Adhesion Barriers

Natural or synthetic physical separators between surfaces during the healing process can reduce the incidence and severity of post-surgical adhesions4,5,7,10,11

Solid barriers (membranes): SEPRAFILM Adhesion Barrier10

Solutions: ADEPT Adhesion Reduction Solution11

Please see the instructions for use for additional information10

Learn more about SEPRAFILM Learn more about ADEPT

Adhesion Prevention: What are my Options in Gynecological Surgery? (5)

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Surgical adhesions are pathological fibrotic connections that form between organ surfaces and the walls of surrounding body cavities following tissue trauma and ischemia.5, 12

Adhesions can negatively affect surgical outcomes as they occasionally cause complications that lead to readmission. An estimated 9% of patients present with adhesion-related conditions within the first year after abdominal surgery, rising to 19% at 4 years and 35% at 10 years.6

Post-surgical adhesion formation is a common complication of any type of surgery, affecting 50–95% of patients regardless of the type of procedure or anatomical location.5

Adhesions are especially common after abdominopelvic procedures, developing after 93% of major abdominal and up to 97% of open gynecologic pelvic operations.13

All patients undergoing surgery are at risk of developing adhesions. However, data suggest that various factors directly or indirectly increase the likelihood of adhesion formation.14

Directly predisposing factors: genetic polymorphisms in the interleukin-I receptor antagonist, increased estrogen exposure, and endometriosis.14

Indirectly predisposing factors: insufficient fibrinolytic activity has been shown to favor adhesion formation.14, 15 Thus, factors affecting the fibrinolytic system can indirectly put a patient at increased risk of post-surgical adhesions. These determinants include certain genetic polymorphisms (plasminogen activator inhibitor-1, thrombin-activatable fibrinolysis inhibitor), underlying conditions (diabetes mellitus, metabolic syndrome, hyperglycemia, obesity, depression, cancer), medication (anti-Parkinsonian or oral hormone therapy), pregnancy, and high alcohol consumption.14

Although many adhesions go unnoticed and do not cause any symptoms, some patients develop severe complications such as small bowel obstruction, chronic pain, and infertility.1, 16

Adhesions can also lead to difficulties in subsequent operations – even if the patient is asymptomatic – as they change the normal anatomy. Obliterated dissection planes and abnormally conjoined organs can increase operation time and complication rates.3, 6 For instance, laparoscopic adhesiolysis carries a 10–25% risk of bowel injury.6

Some women undergoing gynecological procedures develop adhesions that affect their reproductive health, with symptoms ranging from menstrual abnormalities to infertility.17, 18 Indeed, adhesions account for 20–40% of cases of female infertility and can cause severe pregnancy complications such as miscarriages, premature rupture of membrane, premature delivery, or placenta accreta.17, 18

Currently, no effective targeted pharmacotherapies are available to counter existing adhesions.16 If intervention is necessary, the standard approach is surgical adhesiolysis.2 However, reoperation can perpetuate the problem by causing new adhesions or reformation of the existing bands due to the traumatic disruption.2,6,9,19 Thus, the best strategy against adhesive disease is preventing adhesion formation in the initial surgery.

Current anti-adhesion measures can be classified into the following categories.4

1. Surgical technique optimized to minimize tissue damage

2. Adhesion barriers that block physical contact between two injured tissues or organ surfaces

3. Pharmacological agents that counteract inflammation reactions and interfere with adhesion neogenesis

However, although pharmacological agents have shown potential to reduce adhesion formation in clinical studies, off-target and adverse effects limit their use in clinical practice.5

Some groups have suggested that the overall risk of post-surgical adhesions should decrease in the wake of the introduction of laparoscopic surgery.5 However, although some preclinical and clinical data support this hypothesis, conclusive proof that this is the case in clinical practice is currently lacking. A systematic review and meta-analysis of the effect of surgical approach on the incidence of adhesion-related complications found no indication that minimally invasive techniques (e.g., laparoscopy) could improve outcomes.2,8

Despite its limited impact on adhesion-related outcomes, meticulous surgical technique is central to an effective adhesion reduction strategy. Measures include gentle tissue handling, optimal hemostasis, avoiding tissue desiccation, and preventing thermal injury, foreign body reaction, and infection.5,6,9

The key requirement of any adhesion barrier is that it should effectively separate traumatized peritoneal surfaces during the critical period of adhesion development in the 3–5 days after surgery, during which, peritoneal healing occurs.9

Barrier products range from natural to synthetic and can broadly be classified into solid barriers (membranes), gels, or solutions.5

Adhesion barriers have been tested extensively in clinical trials. Several studies have shown that SEPRAFILM Adhesion Barrier, a sodium hyaluronate and carboxymethylcellulose bioresorbable membrane, and ADEPT Adhesion Reduction Solution, a 4% icodextrin solution, reduce the incidence and severity of post-surgical adhesions.10,11,18,20

For instance, a pivotal study assessed the efficacy of SEPRAFILM to reduce the incidence severity, extent and area of adhesion after myomectomy in 127 women at 19 institutions in the United States. The incidence of adhesions to the uterus (number of abdominopelvic locations adherent to the uterus) in patients treated with SEPRAFILM was 4.98 (n=49) compared to control values of 7.88 (n=48) (p<0.0001). The severity of adhesions was reduced from 2.43 (n=65) in the control group to 1.94 (n=54) in the SEPRAFILM group (p<0.01). Reduction in extent scores from 1.68 (n=65) to 1.23 (n=54) (p<0.01) were also demonstrated in the control and SEPRAFILM groups, respectively. The area of the uterus associated with adhesions was reduced from 18.72 (n=54) to 13.23 (n=65) in the patients treated with SEPRAFILM versus control patients (p<0.02). The portion of patients with adnexal adhesions to the posterior uterus was reduced from 69% (n=45) to 52% (n=28) in patients with SEPRAFILM compared to control patients (p<0.01).10,20

Another trial compared the efficacy of ADEPT versus lactated Ringer’s solution (LRS) in reducing adhesion formation following laparoscopy. The study included 402 patients undergoing laparoscopic gynecological surgery with adhesiolysis followed by a second laparoscopy 4–8 weeks later. Significantly more patients in the ADEPT group achieved clinical success – defined as a decrease in adhesions of at least three or 30% between the first and second procedure – versus the LRS group (49% vs. 38%; p=0.018).11,18

Several studies have shown that adhesion barriers have a favorable safety profile.10,11,21,22 A systematic review and meta-analysis of the safety of adhesion barriers for abdominal surgery found that none of the assessed barriers were associated with an increased risk of serious adverse events.21 Likewise, clinical trials of SEPRAFILM and ADEPT used in patients undergoing abdominal or pelvic surgery detected no significant differences between barrier and control groups.18,20,22

INDICATIONS AND IMPORTANT SAFETY INFORMATION

SEPRAFILM Indications for Use

SEPRAFILMAdhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the under-lying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

SEPRAFILM Important Risk Information

SEPRAFILM Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of SEPRAFILM. SEPRAFILMAdhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). SEPRAFILMAdhesion Barrier must be used according to the instructions for use. SEPRAFILMAdhesion Barrier is for single use only, supplied sterile and must not be re-sterilized. Every opened and unused SEPRAFILMpouch must be discarded. Do not use product if pouch is damaged or opened. The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer.

In patients who have ovarian, primary peritoneal or fallopian tube malignancies, SEPRAFILMuse has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required.

The safety and effectiveness of SEPRAFILMAdhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of SEPRAFILMplacement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with SEPRAFILMAdhesion Barrier.

The safety and effectiveness of SEPRAFILMAdhesion Barrier in combination with other adhesion prevention products and/or in other surgical procedures not within the abdominopelvic cavity have not been established in clinical studies.

The safe and effective use of SEPRAFILMAdhesion Barrier in pregnancy and Cesarean section has not been evaluated. No clinical studies have been conducted in pregnant women or women who have become pregnant within the first month after exposure to SEPRAFILMAdhesion Barrier. Therefore, this product is not recommended for use during pregnancy and avoidance of conception should be considered during the first complete menstrual cycle after use of SEPRAFILM Adhesion Barrier.

Long term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies.

Rx Only.For safe and proper use of this device refer to the complete Instructions for Use.

SEPRAFILM Full Instructions For Use

ADEPT® Adhesion Reduction Solution [4% Icodextrin] Indications for Use

ADEPT® Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

ADEPT® Adhesion Reduction Solution [4% Icodextrin]Important Risk Information

ADEPT® Solution is for direct intraperitoneal administration only. NOT for intravenous (IV) administration.

ADEPT® is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease.

ADEPT® is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection. There have been rare reports of sterile peritonitis following the use of icodextrin.

Leakage of ADEPT® from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage through laparoscopic port sites postoperatively. There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia. Anaphylaxis has been reported in a few patients.

Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.

In the pivotal study, the most frequently occurring treatment related adverse events between surgeries were post procedural leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.

Rx Only. For safe and proper use of this device, please refer to full Instructions For Use.

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  2. DeWilde RL, et al. Gynecol Surg. 2012;9:365–368.

  3. Diamond MP, et al. Hum Reprod Update. 2001;7:567–576.

  4. Jeong JJ, et al. PLOS ONE. 2019;14(2):e0212583.

  5. Hassanabad A, et al. Biomolecules. 2021;11(7):1027.

  6. Rajab TK, et al. J R Soc Med. 2010;103:317–321.

  7. Practice Committee of the American Society of Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Fertil Steril. 2019;112:458-463.

  8. ten Broek RPG, et al. Hum Reprod Update. 2012;19:12–25.

  9. DeWilde RL,et al. Gynecol Surg. 2007;4:161–168.

  10. SEPRAFILM Adhesion Barrier Instructions for Use.

  11. ADEPT Adhesion Reduction Solution Instructions for Use.

  12. Sikirica V, et al. BMC Surg. 2011;11:13.

  13. Becker JM. et al. J Am Coll Surg. 1996;183(4):297–306.

  14. Fortin CN, et al. Hum Reprod Update. 2015;21(4):536–551.

  15. Hellebrekers BW, et al. Fertil Steril. 2005;83:122–129.

  16. Tabibian N, et al. Ann Med Surg (Lond). 2017;15 9–13.

  17. Sebbag L, et al. Front Surg. 2019;6:50.

  18. Brown CB, et al. Fertil Steril. 2007;88(5):1413–1426.

  19. Kavic SM, et al. JSLS. 2002;6:99–109.

  20. Diamond MP, et al. Fertil Steril. 1996;66:904-910.

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  22. Beck DE, et al. Dis Colon Rectum. 2003;46:1310–1319.

Adhesion Prevention: What are my Options in Gynecological Surgery? (2024)
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