Trial · NCT07900711
Suture Choice for Ostomy Creation
NCT07900711, Not applicable, Not yet recruiting, University of Southern California
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Suture Choice for Ostomy Creation. Trials, record NCT07900711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suture Choice for Ostomy Creation
- NCT number
- NCT07900711
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 66 participants, estimated
- Lead sponsor
- University of Southern California
- Conditions
Ostomy - Ileostomy or Colostomy, Stoma Complications, Stoma Site Dermatitis, Stoma Site Infection, Peristomal Wound Infection, Peristomal Skin Complication, Stomal Bleeding, Stoma Site Incisional Hernia, Retraction of Colostomy, Retraction of Ileostomy, Stoma Malfunction
- Interventions
- Chromic Gut Suture, Polyglactin 910 Suture
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early Local Stoma Complications | From enrollment up to 90 days post operatively. | Our primary endpoint will be the number of local complications within 45 days. We will assess mucocutaneous separation, skin, irritation, ischemia, prolapse, retraction, bleeding, and peristomal infection. The evaluations will be conducted by study members while inpatient, at clinic follow up, and/or by assessment of patient photographs sent through HIPPA-encrypted email. Evaluations will be completed, and photos will be taken immediately post operatively, during admission, and at two subsequent follow up appointments after discharge from index operation. |
| Secondary | Post-operative Pain After Enterostomy Creation | From enrollment up to 90 days post operatively. | Assess patient-reported peristomal pain using the Visual Analog Scale (VAS) on each side of the enterostomy. The scale is 0 to 10 with 0 indicating "No Pain" and 10 indicating "Worst Pain." The higher the score, the worse the patient's reported pain. |
| Secondary | Adjusted Odds of Stoma Complications by Patient and Stoma Characteristics (Age, Sex, BMI, ASA Class, Comorbidities, Stoma Type) | From enrollment up to 90 days post operatively. | Patient factors will be abstracted from the medical record at enrollment: age (years), sex, BMI (kg/m2, calculated from measured height and weight), ASA physical status class (I-V), smoking status (current/former/never), and presence (yes/no) of diabetes, active malignancy, steroid use, history of chemotherapy or radiation, cardiac disease, and renal disease. Stoma type (end colostomy, end ileostomy, loop colostomy, loop ileostomy) will be recorded in the peri-operative period. The outcome is occurrence of any stoma complication as defined in "Outcome 1" with multivariable logistic regression to estimate the adjusted odds ratio for each factor, with suture type (Chromic vs. Vicryl) as a covariate. |
| Secondary | Surgeon-Reported Suture Handling Score (5-Point Likert Scale Questionnaire) | Immediately following stoma creation (Day 0) | Surgeon experience for each suture type will be measured with a study-specific, 5-point Likert questionnaire. The operating surgeon will complete one for Vicryl suture and one for Chromic suture immediately after stoma maturation. Items included in the questionnaire will be rated from 1 (strongly disagree) to 5 (strongly agree). Items scores will be summed into a total score per suture type with higher scores indicating a better surgeon experience. Mean total scores will be compared between the two sutures. The questionnaire also includes a free-text field for observed intra-operative differences; these will be summarized descriptively and are not part of the score. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900711
GET https://conductscience.org/api/trials/v1/NCT07900711/registered