Adhesion Prevention: What are my Options in Colorectal/General Surgery?

How Common are Adhesions?

Post-surgical adhesion formation is the most common complication of abdominal or pelvic surgery.1 Adhesiolysis is currently the standard treatment approach, but surgical adhesiolysis causes further disruption and adhesion reformation in approximately 97% of patients.2 To further compound this issue, adhesive tissue contains higher levels of growth factors than unaffected peritoneal tissue, suggesting a greater proclivity for adhesion reformation, thus creating a vicious cycle of adhesion formation for patients.3 Therefore, optimal strategies are related to minimizing or preventing adhesion formation in the initial surgery.

97%

Approximate percentage of patients that experience further disruption and adhesion reformation following adhesiolysis.2

Solutions for Adhesion Prevention

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

Surgeons operating on a patient

Pharmacological Agents

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

  • Anticoagulants4
  • Anti-inflammatory agents4
  • Antibiotics for the prevention of infection4

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

Pills spilling out of a pill bottle

Adhesion Barriers

Hyaluronate carboxymethylcellulose [Seprafilm Adhesion Barrier] reduces adhesion formation and the risk of subsequent reoperations for adhesive small bowel obstruction7,8

  • The use of a solid barrier [Seprafilm Adhesion Barrier] seems cost effective in open colorectal surgery7

There are some restrictions on use – for example, the use of barrier membranes should be avoided on fresh anastomotic suture or staple lines as it can increase risk of anastomotic leak and related events8,9

Seprafilm adhesion barrier being held by a pair of surgical tweezers

Adhesion Prevention

Frequently Asked Questions

What are adhesions, and how do they affect surgical outcomes?

Surgical adhesions are pathological fibrotic connections that form between organ surfaces and the walls of surrounding body cavities following tissue trauma and ischemia.5,10

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

How common are post-surgical adhesions?

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 operations.11

Which patients are most at risk of developing adhesions?

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.12

Directly predisposing factors: genetic polymorphisms in the interleukin-I receptor antagonist, increased estrogen exposure, and endometriosis.12

Indirectly predisposing factors: insufficient fibrinolytic activity has been shown to favor adhesion formation.12,13 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.12

What are the main consequences of adhesion formation?

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.1,14

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.6,15 For instance, laparoscopic adhesiolysis carries a 10–25% risk of bowel injury.6

How are adhesions related to small bowel obstruction?

Adhesions are the most common etiology for small bowel obstruction in developed world countries and account for approximately 60% of all episodes.16 In addition, small bowel obstruction is one of the most severe of adhesion-related complications, with a 30-day mortality rate of up to 10%.17

How are adhesions typically treated?

Currently, no effective targeted pharmacotherapies are available to counter existing adhesions.16 If intervention is necessary, the standard approach is surgical adhesiolysis.18 However, reoperation can perpetuate the problem by causing new adhesions or reformation of the existing bands due to the traumatic disruption.6,18-20 Thus, the best strategy against adhesive disease is preventing adhesion formation in the initial surgery.

How can adhesion formation be prevented?

Current anti-adhesion measures can be classified into the following categories4:

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

Can meticulous surgical technique prevent adhesions?

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.11,25

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.5,6,19

How can adhesion barriers help reduce post-surgical adhesions?

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.19

What types of barrier products are available?

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

How effective are adhesion barriers?

Adhesion barriers have been tested extensively in clinical trials. Several studies have shown that Seprafilm Adhesion Barrier, a sodium hyaluronate and carboxymethylcellulose bioresorbable membrane, can reduce the incidence and severity of post-surgical adhesions.8,11

For instance, a pivotal study compared adhesion formation following colectomy and ileal pouch-anal anastomosis with diverting-loop ileostomy with or without the use of Seprafilm.11 Forty-three of 85 patients (51%) in the intervention group were free of adhesions 8–12 weeks after the procedure versus 6% (5/90) of those who underwent surgery without adhesion barrier (p<0.00000000001). Dense adhesions were reported in only 13 patients (15%) who received Seprafilm compared with 52 patients (58%) in the control group (p<0.0001).11

How is the safety profile of adhesion barriers?

The safety of Seprafilm was evaluated in a prospective, randomized, double-blind multicenter study in patients undergoing abdominopelvic surgery for benign diseases of the colon and rectum or small intestinal obstruction.9 There were 981 operative procedures performed on the 882 patients who received Seprafilm, and 1,003 procedures performed in 909 patients in the control group.9 Patients in the Seprafilm group (n=882) received an average of 4.4 sheets (range: less than 3 and up to 10 sheets).9  The incidence of complications between study groups was comparable with 249 (28%) and 223 (25%) of patients experiencing adverse events in the Seprafilm group and control cohort, respectively. No patients had a foreign body reaction.9 Likewise, additional clinical trials of Seprafilm in patients undergoing abdominal or pelvic surgery have detected no significant differences between barrier and control groups.8

Seprafilm Indications and Important Risk Information

SEPRAFILM Indications for Use

Seprafilm Adhesion 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 underlying 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. Seprafilm Adhesion 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). Seprafilm Adhesion Barrier must be used according to the instructions for use. Seprafilm Adhesion Barrier is for single use only, supplied sterile and must not be re-sterilized. Every opened and unused Seprafilm pouch 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, Seprafilm use 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 Seprafilm Adhesion 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 Seprafilm placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with Seprafilm Adhesion Barrier. 

The safety and effectiveness of Seprafilm Adhesion 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 Seprafilm Adhesion 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 Seprafilm Adhesion 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. 

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  8. SEPRAFILM Adhesion Barrier Instructions for Use.
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  18. DeWilde RL, et al. Gynecol Surg. 2012;9:365–368.
  19. DeWilde RL,et al. Gynecol Surg. 2007;4:161–168.
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  21. ten Broek RPG, et al. Hum Reprod Update. 2012;19:12–25.
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