Table 1 Characteristics of the included randomised controlled trials on the efficacy of 4 % icodextrin solution on the prevention of adhesion formation in gynaecological surgery
Study | Brown et al. [1] | diZerega et al. [3] | Trew et al. [5] |
|---|---|---|---|
Patients analysed (n) | 402 | 53 | 330 |
Indication for surgery | Planned laparoscopic gynaecological surgery which included adhesiolysis | Planned laparoscopic gynaecological surgery for pelvic pain and/or infertility problems | Planned laparoscopic gynaecological surgery for primary removal of myomas or endometriotic cysts. (≤4 myomas and largest myoma 2–8 cm in diameter, endometriotic cysts 3–7 cm in diameter) |
Inclusion criteria | All participants were ≥18 years old, in good general health and undergoing laparoscopic gynaecological surgery only. SLL performed 4–16 weeks after initial procedure | ||
Exclusion criteria (common) | Pregnancy, active pelvic/abdominal infection, known allergy to study materials, non-gynaecological procedures to be performed during surgery, cancer, and concomitant use of steroids/antineoplastics/radiation | ||
Exclusion criteria (unique) | <3 available anatomical study sites with adhesions, or <3 sites lysed. | More than half available anatomical study sites contained adhesions. | Conversion to laparotomy, mAFS adhesion score moderate or severe, AFS endometriosis class III or IV (excluding cysts), or adhesions which required lysing |
Time of SLL after initial procedure (weeks) | 4–8 | 6–12 | 4–16 |
Timing of randomisation | Intraoperatively | Recruitment | 24 h prior to surgery |
Method of randomisation | Computer generated | Envelope used, no more information given | Telephone randomisation |
Single or multicentre (n) | Multicentre (16) | Multicentre (not known) | Multicentre (25) |
Presence of blinding | Double-blinded (patient and assessor) | Single-blinded (surgeon) | Double-blinded (patient and assessor) |
Use of independent blinded assessor | Yes | Yes | Yes |
Presence of power calculation | No | No | Yes |
Was analysis intention to treat? | Yes | Yes | Yes |
Timing and location of trial | July 2001-March 2004 USA | Not known USA | September 2003-August 2005 Europe |
Sources of funding | Innovata Ltd, Vectura Group | No sources of funding stated | Shire Pharmaceutical Development Ltd, Baxter BioSurgery |