Suturing Techniques on Perineal Pain

Perineal Pain Clinical Trial

— PNO  

Official title:

The Effect of Continuous Versus Interrupted Suturing Technique on Perineal Pain After Perineorrhaphy: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264194
• Other study ID #: 12411
• Status: Completed
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: January 9, 2023

Study information

• Verified date: June 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Women 18 years or greater planning pelvic floor surgery reconstruction

2. Genital hiatus on POP-Q exam of =4 cm

Exclusion Criteria:

1. History of pelvic radiation

2. History of chronic perineal pain or pudendal neuralgia

3. Planning on having an obliterative vaginal procedure.

4. Concomitant hemorrhoidectomy or colorectal procedure

5. Concomitant mesh removal procedure

6. Allergy to polyglycolic acid sutures

7. History of connective tissue disorder.

8. Chronic immunosuppression

Related Conditions & MeSH terms

• Perineal Pain

Intervention

Other:
• Suturing technique
The technique (subcuticular or transcutaneous) that will be used to close skin post-surgery.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Participants will complete a Situational Pain Scale (SPS) questionnaire. Pain on the SPS is measured from 0 (no pain sensation) to 10 (most intense pain imaginable).	2 weeks
Secondary	Patient satisfaction	Measured using a questionnaire from 1 (very unsatisfied) to 5 (very satisfied).	2 weeks
Secondary	Perineal pain complications	Measured using pelvic exam.	3 months
Secondary	Perineal pain complications	Measured using patient complaints.	3 months