NCT05745909

Brief Summary

The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

February 4, 2023

Last Update Submit

September 14, 2024

Conditions

Rectal NeoplasmsOstomyNeoplasms

Keywords

Rectal cancerLow anterior resectionLoop transverse colostomyLoop ileostomyStoma site infections

Outcome Measures

Primary Outcomes (2)

  • SSI

    incidence of stoma site infections

    60 days after surgery

  • Ileus

    incidence of stoma dysfunction

    60 days after surgery

Secondary Outcomes (6)

  • Readmission rate

    within the first 60 days after surgery

  • Length of hospital stay

    From date of surgery until the date of discharge, assessed up to 60 days

  • Time to stoma closure

    within the first 6 months days after surgery

  • Time to first stool

    60 days after surgery

  • Time to adjuvant postoperative chemotherapy

    within the first 2 months days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Loop transverse colostomy

ACTIVE COMPARATOR

Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop transverse colostomy

Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomy

Loop ileostomy

EXPERIMENTAL

Laparoscopic or open low-anterior resection of the rectum with total mesorectal excision and created loop ileostomy

Procedure: Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomy

Interventions

Laparoscopic or open low-anterior resection of the rectum with TME and created loop transverse colostomyPROCEDURE

The loop transverse colostomy is matured without torsion using a plastic retainer. The stoma protrudes 2-3 cm. The loop of the transverse colon is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

Loop transverse colostomy
Laparoscopic or open low-anterior resection of the rectum with TME and created loop ileostomyPROCEDURE

The loop ileostomy is matured 25-30 cm from the ileocecal angle without torsion and without a retainer, so that stoma protrudes 2-3 cm. The loop of the ileum is sutured with interrupted sutures using an absorbable 3/0 polyglactin suture without piercing the intestinal wall. The intestinal lumen is opened through a transverse incision on the antimesenteric border.

Loop ileostomy

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
  • ECOG status 0-2,
  • ASA≤3.
  • At least 18 years of age
  • Written informed consent

You may not qualify if:

  • Emergency surgery;
  • Previously formed stoma;
  • Stage 4 disease;
  • Obstructive resection of the rectum;
  • Patients older than 79 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Republican clinical oncological dispencery

Ufa, Bashkortostan Republic, 450054, Russia

Location

MeSH Terms

Conditions

Rectal NeoplasmsNeoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

May 31, 2024

Study Completion

July 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

RU(1)