Suturing Techniques on Perineal Pain
Condition: Perineal Pain
Study type: Interventional

Summary: 
      Perineorrhaphy, sometimes referred to as perineoplasty, is a common procedure in pelvic
      reconstructive surgery that entails surgical repair of the perineum. Indications may include:
      prevention of recurrent prolapse, treatment of pain, and improved sexual function and
      cosmesis, as well as to treat the sensation of a "wide vagina." Differences in postoperative
      pain by suturing technique and standard use of suture type are not well established. Patient
      satisfaction can be influenced by patient perceptions regarding postoperative pain, therefore
      reducing postoperative pain scores remains a priority. It is unclear whether suturing
      technique is associated with less pain after this procedure. Based on studies on repair of
      obstetric lacerations, we hypothesize that a subcuticular skin closure will be associated
      with less postoperative perineal pain compared to interrupted transcutaneous sutures.
    

Detailed description: 
      Recruitment will be carried out at OU Medical Center within a 12-month period either at OU
      Women's Pelvic and Bladder Health Clinic or OU Women's Health Clinic. Women who are planning
      pelvic organ prolapse repair and who are found to have genital hiatus of ≥4 cm on the pelvic
      organ prolapse quantification exam will be approached for study inclusion. A 4-cm or greater
      dimension of genital hiatus is associated with greater risk of prolapse recurrence, and
      researchers anticipate patients with this measurement prior to surgery will require a
      perineorrhaphy. These surgeries will be performed by one of two board certified female pelvic
      medicine and reconstructive surgery specialists. Given the nature of the suturing techniques,
      it would be impossible to blind the study to both the investigators and the participants.

      Randomization will be completed prior to the procedure and contained within opaque sealed
      envelopes until a decision is made to proceed with a perineorrhaphy intraoperatively.

      To standardize the procedure, an instructional video will be made to describe the
      subcuticular and transcutaneous interrupted techniques. This will serve as reference for
      investigators to adhere to the standard procedure. An educational webinar will be performed
      at the onset of the study and this instructional video will be available for review at any
      additional point during the study. Participants will be asked to complete a baseline SPS
      questionnaire prior to surgery. Perineorrhaphy will be carried out in our standard fashion
      and finalized with interrupted stitches of delayed absorbable monofilament sutures for
      reconstruction of the perineal body. The perineal skin closure will be randomized to
      continuous subcuticular or interrupted transcutaneous stitches of 3-0 polyglactin-910
      (Vicryl). Researchers will follow the standard Enhanced Recovery After Anesthesia (ERAS)
      protocol for postoperative oral analgesia. Participants will be asked to complete daily SPS
      questionnaires in the first two weeks postoperatively. Patients are routinely scheduled for a
      2- week and 3- month postoperative visit. Participants will complete a questionnaire to
      assess pain (SPS) and patient satisfaction at both visits. A pelvic exam is not routinely
      performed at the 2-week visit unless indicated otherwise by patient or provider concerns. At
      the 3-month postoperative visit, a sexual function questionnaire and a pelvic exam will be
      completed in addition to the pain and patient satisfaction survey. These surveys can be
      administered in person or remotely (by telephone or virtually), depending on the nature of
      the postoperative visits.
    

Intervention name(s): Suturing technique
Intervention type(s): Other
Intervention description(s): The technique (subcuticular or transcutaneous) that will be used to close skin post-surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to receive sutures that will either be hidden underneath their skin (subcuticular) or on your skin (transcutaneous) at the time of skin closure post-surgery.
Masking: None (Open Label)
Primary purpose: Supportive Care