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Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Full bowel preparation
Mechanical bowel preparation only
Sponsored by
N.N. Petrov National Medical Research Center of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, bowel preparation, MBP, Oral antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any use of antibiotics 30 days prior to inclusion
  • 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

Sites / Locations

  • GBUZ Moscow Clinical Scientific Center named after Loginov MHDRecruiting
  • I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive SurgeryRecruiting
  • Lomonosov Moscow State University Medical Research and Educational CenterRecruiting
  • Ryazan State Clinical HospitalRecruiting
  • Scientific-Research institute of Oncology named after N.N. PetrovRecruiting
  • Tomsk Regional Oncology HospitalRecruiting
  • Volgograd State Medical University, Ministry of Health of RussiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full bowel preparation (MBP+OA)

Mechanical bowel preparation only

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incisional surgical site infection (SSI) rate
Rate of incisional SSI in patients after rectal resections

Secondary Outcome Measures

Anastomotic leak rate
Rate of clinical and/or radiological anastomotic leaks
Intraabdominal and or pelvic abscess rate
Overall morbidity
Rate of patients with any complications after surgery
Rate of intraoperative complications
Surgery duration in minutes
Quality of bowel preparation assessed by surgeon
Assessment of bowel preparation quality by surgeon (qualitative scale)
Bowel preparation compliance
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol

Full Information

First Posted
October 12, 2020
Last Updated
September 20, 2022
Sponsor
N.N. Petrov National Medical Research Center of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04592289
Brief Title
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Acronym
REPCA
Official Title
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal resection is performed in both groups. Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required. The intent-to-treat principle is used for the data analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, bowel preparation, MBP, Oral antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
622 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full bowel preparation (MBP+OA)
Arm Type
Experimental
Arm Description
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
Arm Title
Mechanical bowel preparation only
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Full bowel preparation
Intervention Description
MBP+OA
Intervention Type
Procedure
Intervention Name(s)
Mechanical bowel preparation only
Intervention Description
MBP
Primary Outcome Measure Information:
Title
Incisional surgical site infection (SSI) rate
Description
Rate of incisional SSI in patients after rectal resections
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Anastomotic leak rate
Description
Rate of clinical and/or radiological anastomotic leaks
Time Frame
30 days
Title
Intraabdominal and or pelvic abscess rate
Time Frame
30 days
Title
Overall morbidity
Description
Rate of patients with any complications after surgery
Time Frame
30 days
Title
Rate of intraoperative complications
Time Frame
Duration of surgical procedure
Title
Surgery duration in minutes
Time Frame
Duration of surgical procedure
Title
Quality of bowel preparation assessed by surgeon
Description
Assessment of bowel preparation quality by surgeon (qualitative scale)
Time Frame
Day of surgery
Title
Bowel preparation compliance
Description
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Time Frame
Day of surgery

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Any use of antibiotics 30 days prior to inclusion 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Karachun
Phone
+79219462123
Email
dr.a.karachun@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Petrov
Phone
+79214117866
Email
alexpetrov@doctor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksei Karachun
Organizational Affiliation
National Medical Research Centre of Oncology named after N.N. Petrov
Official's Role
Study Chair
Facility Information:
Facility Name
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgy Saakyan
Phone
+79629532211
Email
G.saakian@mknc.ru
First Name & Middle Initial & Last Name & Degree
Oleg Knyazev
First Name & Middle Initial & Last Name & Degree
Georgy Saakyan
Facility Name
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliya Polishchuk
Phone
+79166349069
Email
polishchuk13@gmail.com
First Name & Middle Initial & Last Name & Degree
Fedor Vetshev
First Name & Middle Initial & Last Name & Degree
Liliya Polishchuk
Facility Name
Lomonosov Moscow State University Medical Research and Educational Center
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Garmanova
Phone
+79773429249
Email
Tatianagarmanova@gmail.com
First Name & Middle Initial & Last Name & Degree
Mikhail Agapov
First Name & Middle Initial & Last Name & Degree
Tatiana Garmanova
Facility Name
Ryazan State Clinical Hospital
City
Ryazan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Ignatov
Phone
+79065440152
Email
ignatov.mac93@mail.ru
First Name & Middle Initial & Last Name & Degree
Ivan Ignatov
Facility Name
Scientific-Research institute of Oncology named after N.N. Petrov
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksei Petrov
Phone
+79214117866
Email
alexpetrov@doctor.com
First Name & Middle Initial & Last Name & Degree
Aleksei Karachun
First Name & Middle Initial & Last Name & Degree
Aleksei Petrov
Facility Name
Tomsk Regional Oncology Hospital
City
Tomsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeniy Drozdov
Phone
+79234186405
Email
e.s.drozdov@tomonco.ru
First Name & Middle Initial & Last Name & Degree
Evgeniy Drozdov
Facility Name
Volgograd State Medical University, Ministry of Health of Russia
City
Volgograd
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Postolov
Phone
+79093845833
Email
1postolov1@mail.ru
First Name & Middle Initial & Last Name & Degree
Victoriya Zhavoronkova
First Name & Middle Initial & Last Name & Degree
Mikhail Postolov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share individual participant data

Learn more about this trial

Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone

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