Single Versus Double Stapling and Two Purse-String Techniques in Rectal Cancer Surgery
NCT07929415, Not applicable, Recruiting, Alexandria University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Single Versus Double Stapling and Two Purse-String Techniques in Rectal Cancer Surgery | ClinicalTrials.gov |
| NCT number | NCT07929415 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 124 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Alexandria University | ClinicalTrials.gov |
| Conditions | Rectal Cancer | ClinicalTrials.gov |
| Interventions | Double-Stapled Anastomosis, Single-Stapled Anastomosis With Intracorporeal Purse-String, Single-Stapled Anastomosis With Transanal Purse-String | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Clinically Significant Anastomotic Leak Within 30 Days | Within 30 days after surgery | Percentage of participants with an anastomotic leak classified as Grade B or Grade C according to the International Study Group of Rectal Cancer classification. Grade B requires active treatment without relaparotomy, and Grade C requires relaparotomy. The primary comparison will be between the combined single-stapling group and the double-stapling group. | ClinicalTrials.gov |
| Secondary | Postoperative Complications According to the Clavien-Dindo Classification | Within 30 and 90 days after surgery | Percentage of participants experiencing postoperative complications, with severity classified using the Clavien-Dindo system. Complications will be assessed cumulatively at 30 and 90 days after surgery, and the highest complication grade experienced by each participant will be recorded at each assessment. | ClinicalTrials.gov |
| Secondary | Operative Time | During the index operation | Duration of the surgical procedure, measured in minutes. | ClinicalTrials.gov |
| Secondary | Estimated Intraoperative Blood Loss | During the index operation | Estimated volume of blood lost during the surgical procedure, measured in milliliters. | ClinicalTrials.gov |
| Secondary | Conversion From Minimally Invasive to Open Surgery | During the index operation | Percentage of participants whose planned minimally invasive procedure is converted to open surgery. The denominator will include participants in whom a minimally invasive approach was initially attempted. | ClinicalTrials.gov |
| Secondary | Postoperative Length of Hospital Stay | From surgery to up to 10 weeks | Number of days from the index operation to discharge from the index hospital admission. | ClinicalTrials.gov |
| Secondary | Bowel Function Assessed Using the Low Anterior Resection Syndrome Score | At 6 and 12 months after surgery | Bowel function will be assessed using the five-item Low Anterior Resection Syndrome (LARS) score. Total scores range from 0 to 42, with higher scores indicating worse bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS. Scores will be evaluated separately at each assessment. | ClinicalTrials.gov |
| Secondary | Fecal Incontinence Assessed Using the Wexner Incontinence Score | At 6 and 12 months after surgery | Fecal incontinence will be assessed using the Wexner (Cleveland Clinic) Incontinence Score. The five-item score evaluates incontinence to solid stool, liquid stool, and gas, pad use, and lifestyle alteration. Total scores range from 0 to 20, with 0 indicating no incontinence and higher scores indicating more severe incontinence. Scores will be evaluated separately at each assessment. | ClinicalTrials.gov |
| Secondary | Health-Related Quality of Life Assessed Using the EORTC QLQ-C30 | At 6 and 12 months after surgery | Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Global health status/quality of life, functional scales, and symptom scales and items will be scored separately according to the scoring manual. Scores range from 0 to 100. Higher global health and functional scores indicate better quality of life or functioning; higher symptom scores indicate worse symptoms. Scores will be evaluated separately at each assessment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)