Perineal PainPNONCT05264194
Suturing Techniques on Perineal Pain
A study testing Suturing technique in people with Perineal Pain, run by University of Oklahoma at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Perineal Pain
- What is being tested?
- Suturing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or greater planning pelvic floor surgery reconstruction
- Genital hiatus on POP-Q exam of ≥4 cm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Perineal Pain
- Being tested
- Suturing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing techniqueOther
The technique (subcuticular or transcutaneous) that will be used to close skin post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving subcuticular suturing | Active comparator | Sutures will be hidden underneath skin Receives: Other: Suturing technique |
| Patients receiving transcutaneous suturing | Active comparator | Sutures will be on your skin Receives: Other: Suturing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (3)
Patient satisfaction
Measured using a questionnaire from 1 (very unsatisfied) to 5 (very satisfied).
Measured: 2 weeks
Perineal pain complications
Measured using pelvic exam.
Measured: 3 months
Perineal pain complications
Measured using patient complaints.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start10 Oct 2020
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieschen Quiroz, MD, Principal investigator, University of Oklahoma HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264194
- Sponsor's protocol ID
- 12411
- Acronym
- PNO
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Versus Interrupted Suturing Technique on Perineal Pain After Perineorrhaphy: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05264194
- Acronym / sponsor ID
- PNO / 12411
- Conditions
- Perineal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving subcuticular suturing | Active comparator | Other: Suturing techniqueSutures will be hidden underneath skin |
| Patients receiving transcutaneous suturing | Active comparator | Other: Suturing techniqueSutures will be on your skin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women 18 years or greater planning pelvic floor surgery reconstruction
- Genital hiatus on POP-Q exam of ≥4 cm
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suturing techniqueThe technique (subcuticular or transcutaneous) that will be used to close skin post-surgery. | Other | Patients receiving subcuticular suturing, Patients receiving transcutaneous suturing |
Primary outcome
Pain level
Time frame: 2 weeks
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).
3 secondary outcomes
Patient satisfaction
Time frame: 2 weeks
Perineal pain complications
Time frame: 3 months
Perineal pain complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieschen Quiroz, MD principal investigator
University of Oklahoma HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing technique in people with Perineal Pain, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.