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. 2020 Mar 22;2020(3):CD000475. doi: 10.1002/14651858.CD000475.pub4

Franklin 1995.

Methods Unit of randomisation: ovary
 Method of randomisation: blocks of 2 with sealed envelopes
 Timing of randomisation: during surgery
 Blinding: yes
57 participants randomly assigned
 2 exclusions
 55 participants (110 ovaries) analysed
Trial supported by manufacturers of Interceed (Johnson & Johnson Medical, Inc.)
Participants Patients undergoing bilateral ovarian surgery by laparotomy (N = 55)
 Dropouts: not stated
 Indication for surgery: bilateral ovarian disease (adhesions 37; tubal occlusion 7; PID history 4; endometriosis 5; other 2); not exclusively participants with infertility
 Pre‐existing adhesions: some (39/55)
 Cause of adhesions: not stated (endometriosis included)
 Microsurgery at surgeon's discretion
Age, mean, years: 29.9 (range 22 to 41)
Location: 6 centres (Houston, Texas; Detroit, Michigan; Richmond, Virginia; Grand Rapids, Michigan ‐ USA; Sydney ‐ Australia; Danderyd ‐ Sweden)
 Timing and duration: 1990 to 1993
Interventions Oxidised regenerated cellulose on ovary vs uncovered opposite ovary
Other adjuvants used: none
Second‐look laparoscopy

  1. Timing: 10 to 98 days after initial surgery

  2. Surgeon unaware: not stated

  3. Adhesiolysis: yes
Outcomes Adhesions at second‐look laparoscopy: second or third week

  1. Incidence:

    1. Per pelvic sidewall

    2. Matched pair analysis

    3. According to diagnosis

  2. Extent:

    1. Area (measured with laparoscopic probe)

    2. Area differential

    3. % improvement

    4. According to diagnosis (area differential)

    5. According to time interval to SLL (area differential)

  3. Severity:

    1. Graded 0 to 3 (0 = no adhesions; 1 = filmy adhesions; 2 = organised adhesions; 3 = cohesive adhesions)

    2. Grade differential


Pregnancy outcomes: nil
 Adverse effects
Notes Power calculations: nil
 Preliminary report of this trial published as abstract in 1993 (see references)
 Documentation: video
 Sponsored by Johnson & Johnson
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear description of method of randomisation provided
Quote: "before beginning the study, a treatment randomisation scheme was generated. Patients were randomised in blocks of two to provide balance with respect to the left and right ovaries"
Allocation concealment (selection bias) Unclear risk Sealed envelopes used to conceal allocations; unclear but appear to have been created after randomisation already decided
Quote: "randomised treatment assignments were placed in sealed envelope for each patient, thereby blinding the surgeon to the treatment assignment during surgery"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unit of randomisation was by ovary, so each participant received both intervention and control
Surgeon was not blinded, but treatment assignment was revealed only intraoperatively: "randomized treatment assignments were placed in sealed envelopes for each patient, thereby blinding the surgeon to the treatment assignment during surgery. At that time, a sealed envelope was opened, disclosing the assignment of either the left or right ovary for wrapping with Interceed"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk It is not stated whether the surgeon performing SLL was blinded to which ovary received which intervention
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 exclusions (out of 57 participants): 1 due to complete lysis of adhesions, and the second due to severe adhesions of pelvic wall at SLL
Selective reporting (reporting bias) Unclear risk Data presented as numbers of cases; no data conversion. P values stated for outcomes. No omission of outcomes and no subsets of data. No pre‐published protocol identified
Other bias Low risk No other bias identified