NCT04592289

Brief Summary

The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

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

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

October 12, 2020

Last Update Submit

November 16, 2023

Conditions

Rectal Cancer

Keywords

rectal cancerbowel preparationMBPOral antibiotics

Outcome Measures

Primary Outcomes (1)

  • Incisional surgical site infection (SSI) rate

    Rate of incisional SSI in patients after rectal resections

    30 days

Secondary Outcomes (7)

  • Anastomotic leak rate

    30 days

  • Intraabdominal and or pelvic abscess rate

    30 days

  • Overall morbidity

    30 days

  • Rate of intraoperative complications

    Duration of surgical procedure

  • Surgery duration in minutes

    Duration of surgical procedure

  • +2 more secondary outcomes

Study Arms (2)

Full bowel preparation (MBP+OA)

EXPERIMENTAL

Rifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml

Procedure: Full bowel preparation

Mechanical bowel preparation only

ACTIVE COMPARATOR

Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml

Procedure: Mechanical bowel preparation only

Interventions

Full bowel preparationPROCEDURE

MBP+OA

Full bowel preparation (MBP+OA)
Mechanical bowel preparation onlyPROCEDURE

MBP

Mechanical bowel preparation only

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction
  • clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
  • indications for surgical rectal resection
  • ECOG status 0-2
  • At least 18 years of age
  • Written informed consent

You may not qualify if:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
  • Pregnancy or breast feeding
  • Medical contraindications for surgical treatment
  • Functioning stoma
  • Contraindications for use of MBP or OA drugs or their components
  • Indications for obstructive resection or abdominoperineal excision
  • Acute bowel obstruction, bleeding or perforation
  • Other malignancies not in remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GBUZ Moscow Clinical Scientific Center named after Loginov MHD

Moscow, Russia

RECRUITING

I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery

Moscow, Russia

RECRUITING

Lomonosov Moscow State University Medical Research and Educational Center

Moscow, Russia

RECRUITING

Ryazan State Clinical Hospital

Ryazan, Russia

RECRUITING

Scientific-Research institute of Oncology named after N.N. Petrov

Saint Petersburg, 197758, Russia

RECRUITING

Tomsk Regional Oncology Hospital

Tomsk, Russia

RECRUITING

Volgograd State Medical University, Ministry of Health of Russia

Volgograd, Russia

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Aleksei Karachun

    National Medical Research Centre of Oncology named after N.N. Petrov

    STUDY CHAIR

Central Study Contacts

Aleksei Karachun

CONTACT

+79219462123dr.a.karachun@gmail.com

Aleksei Petrov

CONTACT

+79214117866alexpetrov@doctor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 30, 2020

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

We are not planning to share individual participant data

Locations

RU(7)