Suturing Techniques on Perineal Pain

NCT05264194 | Completed

• 1 other identifier: 12411
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perineal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient satisfaction

  2 weeks

• Perineal pain complications

  3 months

• Perineal pain complications

  3 months

Study Arms (2)

Patients receiving subcuticular suturing

ACTIVE COMPARATOR

Sutures will be hidden underneath skin

Other: Suturing technique

Patients receiving transcutaneous suturing

ACTIVE COMPARATOR

Sutures will be on your skin

Other: Suturing technique

Interventions

Suturing technique OTHER

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

Patients receiving subcuticular suturing; Patients receiving transcutaneous suturing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: This study involves those undergoing a pelvic reconstructive surgery, more common for women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years or greater planning pelvic floor surgery reconstruction
• Genital hiatus on POP-Q exam of ≥4 cm

You may not qualify if:

• History of pelvic radiation
• History of chronic perineal pain or pudendal neuralgia
• Planning on having an obliterative vaginal procedure.
• Concomitant hemorrhoidectomy or colorectal procedure
• Concomitant mesh removal procedure
• Allergy to polyglycolic acid sutures
• History of connective tissue disorder.
• Chronic immunosuppression

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Suture Techniques

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative

Study Officials

• Lieschen Quiroz, MD

  University of Oklahoma HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the suturing techniques, it would be impossible to blind the study to the investigators and the participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 3, 2022
• Study Start: October 10, 2020
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)