Suturing Techniques on Perineal Pain (PNO)

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

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.

Study Overview

• Status: Completed
• Conditions: Perineal Pain
• Intervention / Treatment: Other: Suturing technique

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients receiving subcuticular suturing; Sutures will be hidden underneath skin	Other: Suturing technique; The technique (subcuticular or transcutaneous) that will be used to close skin post-surgery.
Active Comparator: Patients receiving transcutaneous suturing; Sutures will be on your skin	Other: Suturing technique; The technique (subcuticular or transcutaneous) that will be used to close skin post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Measured using a questionnaire from 1 (very unsatisfied) to 5 (very satisfied).	2 weeks
Perineal pain complications	Measured using pelvic exam.	3 months
Perineal pain complications	Measured using patient complaints.	3 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Lieschen Quiroz, MD, University of Oklahoma HSC

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 12411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No